Drugs Details

Drugs Info of Menomune A/C/Y/W-135
Drugs Details
  • Drugs Type  : Multum
  • Date : 27th Feb 2015 04:21 am
  • Brand Name : Menomune A/C/Y/W-135
  • Generic Name : meningococcal polysaccharide vaccine (Pronunciation: me NIN je KOK al POL ee SAK a ride vax EEN)
Descriptions

Menomune - A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W- 135 Combined, is a vaccine for subcutaneous injection. Menomune - A/C/Y/W-135 vaccine consists of a sterile lyophilized preparation of the group-specific polysaccharide antigens from N meningitidis, Group A, Group C, Group Y, and Group W-135. Nmeningitidis are cultivated on Mueller Hinton casein agar7 and grown in Watson Scherp casamino acid media8. The purified polysaccharide is extracted from the N meningitidis cells and separated from the media by procedures which include centrifugation, detergent precipitation, alcohol precipitation, solvent or organic extraction, and diafiltration. No preservative is added during manufacture.

The diluent (0.6 mL) for the single dose presentation contains sterile, pyrogen-free distilled water without preservative. The diluent (6 mL) for the multidose presentation contains sterile, pyrogen-free distilled water andthimerosal, a mercury derivative, which is added as a preservative for the reconstituted vaccine. [See HOW SUPPLIED/Storage and Handling]

After reconstitution with diluent, the vaccine is a clear colorless liquid solution. Each 0.5 mL dose contains 50 mcg of polysaccharide from each of serogroups A, C, Y, and W-135. Reconstituted vaccine from a multidose vial also contains 25 mcg mercury per dose.

Each dose of vaccine contains 2.5 mg to 5 mg of lactose added as a stabilizer.9

Potency is evaluated by measuring the molecular size of each polysaccharide component using a column chromatography method as standardized by the US Food and Drug Administration (FDA) and the World Health Organization (WHO)10 for Meningococcal Polysaccharide Vaccine.

REFERENCES

7 Mueller H, et al. A protein-free medium for primary isolation of the gonococcus and meningococcus. Proc Soc Exp Biol Med 1941;48:330.

8 Watson RG, et al. The specific hapten of group C (group II a) meningococcus. II. Chemical nature. J Immunol. 1958;81:337.

9 Tiesjema RH, et al. Enhanced stability of meningococcal polysaccharidevaccines by using lactose as a menstruum for lyophilization. Bull WHO 1977;55:43-48.

10 WHO Technical Report Series, 1981;No.658.

 

What are the possible side effects of this vaccine (Menomune A/C/Y/W-135)?

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Developing meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic...

Read All Potential Side Effects and See Pictures of Menomune »

What are the precautions when taking meningococcal polysaccharide vaccine (Menomune)?

See also How to Use and Drug Interactions sections.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness or fever, immune system problems (e.g., due to cancer treatment, organ transplant, HIV).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more...

Read All Potential Precautions of Menomune »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

Menomune® - A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, is indicated for active immunizationfor the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menomune - A/C/Y/W-135 vaccine is approved for use in persons 2 years of age and older. Menomune - A/C/Y/W-135 vaccine does not prevent N meningitidis serogroup B disease.

Dosage Administration

Administration

The package contains a vial of lyophilized vaccine and a vial of diluent. The lyophilized vaccine should be a white or off-white color to a light beige color. The diluent used for reconstitution is a clear liquid.

After removing the “flip-off” caps, cleanse the vaccine and diluent vial stoppers with a suitable germicide. Do not remove the vial stoppers or metal seals holding them in place. Using a suitable sterile needle and syringe andaseptic technique, withdraw the supplied diluent (0.6 mL for single dose presentation and 6.0 mL for multidose presentation) (Refer to Figure 1) and inject into the vial containing the lyophilized vaccine (Refer to Figure 2). Swirl the vial until the vaccine is thoroughly dissolved (Refer to Figure 3). When reconstituted, the vaccine should be a clear, colorless liquid.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

Using a suitable sterile needle and syringe and aseptic technique, withdraw (Refer to Figure 4) and administer a 0.5 mL dose of Menomune - A/C/Y/W-135 vaccine by subcutaneous injection. Use a separate sterile needle and syringe and aseptic technique for each dose withdrawn from the multidose vial.

Do not administer this product intravenously or intramuscularly.

The preferred site of administration is the deltoid region.

Menomune vaccine: Instructions for reconstitution

Figure 1

Withdraw 0.6 mL of the supplied diluent - Illustration

 

For the single-dose presentation, withdraw 0.6 mL of the supplied diluent; for the multidose presentation, withdraw 6.0 mL.

Figure 2

Insert the syringe needle through the stopper of the vial - Illustration

 

Insert the syringe needle through the stopper of the vial of lyophilized Menomune vaccine component and inject the diluent into the vial.

Figure 3

Swirl the vial - Illustration

 

Swirl the vial until the lyophilized vaccine component is thoroughly dissolved.

Figure 4

Withdraw 0.5 mL of Menomune vaccine -  Illustration

 

After reconstitution, withdraw 0.5 mL of Menomune vaccine and administer subcutaneously. Use the single-dose presentation immediately after reconstitution. The multidose presentation may be used for up to 35 days after reconstitution if stored at 2° to 8°C.

The vaccine should not be combined through reconstitution or mixed with any other vaccine.

Vaccine supplied in single dose vials should be used immediately after reconstitution. Vaccine supplied in multidose vials may be used for up to 35 days after reconstitution if stored at 2° to 8°C (35° to 46°F). [See HOW SUPPLIED/Storage and Handling]

Primary Immunization

Primary immunization with Menomune - A/C/Y/W-135 vaccine consists of a single 0.5 mL dose administered subcutaneously.

The ACIP (Advisory Committee on Immunization Practices) has specific recommendations for use of meningococcal vaccines.1,2,3

Revaccination

The ACIP has recommendations for revaccination against meningococcal disease for persons at high risk who were previously vaccinated with Menomune - A/C/Y/W-135 vaccine.1,3 If Menomune - A/C/Y/W-135 vaccine is used for revaccination, the dose is 0.5 mL administered subcutaneously.

How Supplied

Dosage Forms And Strengths

Menomune - A/C/Y/W-135 vaccine is supplied as a lyophilized vaccine, in a single dose or a multidose (10 dose) vial, with corresponding single dose or multidose vial of diluent. The lyophilized vaccine is reconstituted with the diluent [see DOSAGE AND ADMINISTRATION]. After reconstitution, each dose consists of a 0.5 mL solution for injection. See DESCRIPTION for the complete listing of ingredients.

Storage And Handling

One single dose vial of lyophilized vaccine (NDC 49281-487-58) with one 0.6 mL vial of diluents (NDC 49281-466-08) (contains no preservative). Supplied as package NDC 49281-489-01.

One 10 dose vial of lyophilized vaccine (NDC 49281-488-78) with one 6.0 mL vial of diluents (NDC 49281-466-91) (contains preservative). Supplied as package NDC 49281-489-91.

Storage

Store lyophilized vaccine, diluent, and reconstituted vaccine, when not in use, at 2° to 8°C (35° to 46°F). Do not freeze.

Do not use after the expiration date shown on the vial labels of the lyophilized vaccine and diluent.

Discard remainder of reconstituted vaccine from multidose vials within 35 days after reconstitution. Vaccine from single dose vials should be used immediately after reconstitution.

REFERENCES

1 Centers for Disease Control and Prevention. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2005;54 (No. RR - 7): 1-21.

2 Centers for Disease Control and Prevention. Revised recommendations of the Advisory Committee on Immunization Practices to vaccinate all persons aged 11-18 years with meningococcal conjugate vaccine. MMWR 2007;56:794-5.

3 Centers for Disease Control and Prevention. Recommendation from the Advisory Committee on Immunization Practices (ACIP) for use of quadrivalent meningococcal conjugate vaccine (MCV4) in children aged 2-10 years at increased risk for invasive meningococcal disease. MMWR 2007;56:1265-6.

Manufactured by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA. Revised: Apr 2013

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Data From Clinical Studies

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in clinical practice.

In three clinical trials primarily designed to assess the safety and immunogenicity of another vaccine, Menactra® [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine], participants were randomized to receive Menactra or Menomune - A/C/Y/W-135 vaccine, which was used as a control vaccine. In these three trials, 1519 children 2-10 years of age, 972 persons 11-18 years of age, and 1170 adults 18-55 years of age, respectively, received a dose of Menomune - A/C/Y/W-135 vaccine. Overall, of the children 210 years of age who received Menactra or Menomune - A/C/Y/W-135 vaccine, 68% were enrolled at US sites and 32% were enrolled at a Chilean site. The median ages of US and Chilean children were 6 and 5 years, respectively; overall, 50.5% were males and 92.0% were Caucasian. Among participants 11-55 years of age who received Menactra or Menomune - A/C/Y/W-135 vaccine, all were enrolled at US sites; 54.8% were female; 87.7% were Caucasian.

Solicited local and systemic reactions were monitored daily for 7 days post-vaccination using a diary card. Information on serious adverse events was collected at interim clinic visits and by telephone interview conducted 6 months post-vaccination. At least 94% of participants from the three studies completed the 6-month follow-up.

Serious Adverse Events

Across the three studies, serious adverse events within 6-months following Menomune - A/C/Y/W-135 vaccine were reported in 0.7% of 1519 children 2-10 years of age, 0.6% of 972 persons 11-18 years of age, and 1.7% of 1170 persons 18-55 years of age.

Solicited Adverse Eventsa

The most commonly reported solicited adverse events in US children 2-10 years of age were injection site pain, irritability, and diarrhea. (Table 1)

The most commonly reported solicited adverse events in adolescents, ages 11-18 years, and adults, ages 18-55 years, were injection site pain, headache, and fatigue. (Table 2)

Table 1: Percentage of US Participants 2-10 Years of Age Reporting Solicited Adverse Events Within 7 Days Following Administration of Menomune - A/C/Y/W-135 Vaccine

EVENT N=1019-1027*
ANY % MODERATE % SEVERE %
General disorders and administration site conditions
Injection site reaction
Pain† 26.1 2.5 0.0
Redness‡ 7.9 0.5 0.0
Induration‡ 4.2 0.6 0.0
Swelling‡ 2.8 0.3 0.0
Systemic events
Fever§ 5.2 1.7 0.2
Gastrointestinal disorders
Anorexia|| 8.7 1.3 0.8
Vomiting¶ 2.7 0.7 0.6
Diarrhea# 11.8 2.5 0.3
Nervous system disorders
Drowsiness** 11.2 2.5 0.5
Irritability†† 12.2 2.6 0.6
Seizures‡‡ 0.0 N/A N/A
Musculoskeletal and connective tissue disorders
Arthralgia§§ 5.3 0.7 0.0
Skin and subcutaneous disorders
Rash‡‡ 3.0 N/A N/A
* N = The total number of participants with reported data. The N is 1027 for all solicited events except fever (N=1019). The percentage is based on N.
† Moderate: Discomforting, interfered with or limited usual arm movement, Severe: Disabling, child unable to move arm.
‡ Moderate: 1.0-2.0 inches; Severe: > 2.0 inches.
§ Oral equivalent temperature; Moderate: 38.4-39.4°C, Severe: ≥ 39.5°C.
|| Moderate: Skipped 2 meals, Severe: skipped ≥ 3 meals.
Moderate: 2 episodes, Severe: ≥ 3 episodes.
# Moderate: 3-4 episodes, Severe: ≥ 5 episodes.
** Moderate: Interferes with normal activities, Severe: disabling, unwilling to engage in play or interaction with others.
†† Moderate: 1-3 hours duration, Severe: > 3 hours duration.
‡‡ These solicited adverse events were reported as present or absent only.
§§ Moderate: Decreased range of motion due to pain or discomfort, Severe: unable to move major joints because of pain.

 

Table 2: Percentage of Participants 11-55 Years of Age Reporting Solicited Adverse Events Within 7 Days Following Administration of Menomune - A/C/Y/W-135 Vaccine

EVENT STUDY 1 N*=970 STUDY 2 N*=1159
PARTICIPANTS 11-18 YEARS OF AGE PARTICIPANTS 18-55 YEARS OF AGE
ANY MODERATE SEVERE ANY MODERATE SEVERE
General disorders and administration site conditions
Injection site reaction
Pain† 28.7 2.6 0.0 48.1 3.3 0.1
Redness‡ 5.7 0.4 0.0 16.0 1.9 0.1
Induration‡ 5.2 0.5 0.0 11.0 1.0 0.0
Swelling‡ 3.6 0.3 0.0 7.6 0.7 0.0
Systemic events
Fatigue§ 25.1 6.2 0.2 32.3 6.6 0.4
Malaise§ 16.8 3.4 0.4 22.3 4.7 0.9
Chills§ 3.5 0.4 0.1 5.6 1.0 0.0
Fever|| 3.0 0.3 0.1 0.5 0.1 0.0
Gastrointestinal disorders
Diarrhea¶ 10.2 1.3 0.0 14.0 2.9 0.3
Anorexia# 7.7 1.1 0.2 9.9 1.6 0.4
Vomiting** 1.4 0.5 0.3 1.5 0.2 0.4
Nervous system disorders
Headache†† 29.3 6.5 0.4 41.8 8.9 0.9
Seizure‡‡ 0.0 N/A N/A 0.0 N/A N/A
             
Musculoskeletal and connective tissue disorders
Arthralgia§ 10.2 2.1 0.1 16.0 2.6 0.1
Skin and subcutaneous disorders
Rash‡‡ 1.4 N/A N/A 0.8 N/A N/A
* N=Total number of participants with data.
† Moderate: Discomforting, interfered with or limited usual arm movement, Severe: Disabling, unable to move arm.
‡ Moderate: 1.0-2.0 inches; Severe: > 2.0 inches.
§ Moderate: Interferes with normal activities, Severe: disabling, requires bed rest.
|| Oral equivalent temperature. Study 1: Moderate: 38.5-39.4°C, Severe: ≥ 39.5°C. Study 2: Moderate 39.0- 39.9°C, Severe: ≥ 40.0°C.
¶Moderate: 3-4 episodes, Severe: ≥ 5 episodes.
# Moderate: Skipped 2 meals, Severe: skipped ≥ 3 meals.
** Moderate: 2 episodes, Severe: ≥ 3 episodes.
†† Moderate: discomforting enough to interfere with activities, Severe: disabling requires bed rest and analgesics.
‡‡ These solicited adverse events were reported as present or absent only.

 

Data From Post-Marketing Experience

The following adverse events have been spontaneously reported during post-approval use of Menomune - A/C/Y/W-135 vaccine since 1993 through November 2008. Because these events were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to Menomune - A/C/Y/W-135 vaccine exposure.

The following adverse events were included based on severity, frequency of reporting or the strength of causal association to Menomune - A/C/Y/W-135 vaccine.

Immune System Disorders

Hypersensitivity, such as rash, urticaria, pruritus, dyspnea, angioedema

Nervous System Disorders

Headache, vasovagal syncope, dizziness, paresthesia, Guillain-Barre syndrome

Gastrointestinal Disorders

Nausea, vomiting, diarrhea

Musculoskeletal and Connective Tissue Disorders

Myalgia, arthralgia

General Disorders and Administration Site Conditions

Fever, injection site reaction, malaise, asthenia, chills, fatigue

Read the Menomune (meningococcal polysaccharide vaccine) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

Separate syringes and injection sites must be used in case of concomitant administration.

Do not mix Menomune - A/C/Y/W-135 vaccine with other vaccines in the same syringe or vial.

Immunosuppressive therapies may reduce the immune response to Menomune - A/C/Y/W-135 vaccine.

No safety and immunogenicity data are available on the concomitant administration of Menomune - A/C/Y/W-135 vaccine with other US licensed vaccines.

Read the Menomune Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Latex

The stoppers to the vials of lyophilized vaccine and diluent contain dry natural latex rubber that may cause allergic reactions in latex sensitive persons.

Management Of Acute Allergic Reactions

Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of the vaccine.

Moderate Or Severe Acute Illness

To avoid diagnostic confusion between manifestations of an acute illnessand possible vaccine adverse effects, vaccination with Menomune - A/C/Y/W-135 vaccine should be postponed in persons with moderate or severe acute illness.4

Limitations Of Vaccine Effectiveness

Menomune - A/C/Y/W-135 vaccine may not protect all recipients.

Altered Immunocompetence

Persons who are immunosuppressed, including persons receivingimmunosuppressive therapy, may have a diminished immune response to Menomune - A/C/Y/W-135 vaccine [see DRUG INTERACTIONS].

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Menomune -A/C/Y/W-135 vaccine. It is also not known whether Menomune - A/C/Y/W-135 vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Menomune - A/C/Y/W-135 vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Menomune - A/C/Y/W-135 vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Menomune - A/C/Y/W-135 vaccine is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Menomune - A/C/Y/W-135 vaccine in children below the age of 2 years have not been established.

During a meningococcal serogroup A epidemic in sub-Saharan Africa, children 3 months to 16 years of age were vaccinated with a high molecular weight serogroup A/C meningococcal polysaccharide vaccine. In case-control studies, after 1 year of observation, vaccine efficacy against meningococcal serogroup A disease was estimated to be 87% [90% Confidence Interval (CI), 52% to 96%], overall. After 3 years, efficacy was estimated to be 67% (90% CI, 40% to 82%) among children who were 4-16 years of age at the time of vaccination and 8% (90% CI, -102% to 58%) among children who were 1-3 years of age at the time of vaccination.5

The efficacy of a serogroup C meningococcal vaccine in infants and young children was evaluated in a placebo-controlled trial during a serogroup C epidemic in Brazil. Vaccine efficacy was estimated to be 12% (95% CI, -55% to 62%) among children 6 to 23 months of age and 55% (95% CI, -4% to 72%) among children 24 to 36 months of age.6

Geriatric Use

Clinical studies of Menomune - A/C/Y/W-135 vaccine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

REFERENCES

4 Recommendations of the Advisory Committee on Immunization Practices (ACIP) General Recommendations on Immunization. MMWR 2006 December 01;55(RR15):1-48.

5 Reingold AL, et al. Age-specific differences in duration of clinical protection after vaccination with meningococcal polysaccharide A vaccine. Lancet. 1985;No.8447:114-118.

6 Granoff DM, et al. Meningococcal vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008:399-434.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

Hypersensitivity

Do not administer to anyone with a history of a severe allergic reaction (e.g.,anaphylaxis) to Menomune - A/C/Y/W-135 vaccine or any component of the vaccine [see DESCRIPTION].

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

The presence of bactericidal anti-capsular meningococcal antibodies has been associated with protection from invasive meningococcal disease.11,12Menomune - A/C/Y/W-135 vaccine induces the production of bactericidal antibodies specific to the capsular polysaccharides of serogroups A, C, Y, and W-135.

Non-Clinical Toxicology

Carcinogenesis, mutagenesis, impairment Of fertility

Menomune - A/C/Y/W-135 vaccine has not been evaluated for carcinogenicor mutagenic potential or impairment of fertility.

Clinical Studies

Effectiveness of Menomune - A/C/Y/W-135 vaccine was inferred by evaluating the proportion of children 2-10 years of age achieving a pre-specified level of serum bactericidal antibody and the proportion of persons 11-55 years of age achieving a 4-fold increase from baseline in serum bactericidal antibody, for each serogroup. Evidence for clinical efficacy against serogroupspecific meningococcal disease in school-age children and adults has been obtained from historical field trials and observational studies with other high molecular weight polysaccharide vaccines containing meningococcal serogroup A and/or C components.6 No studies have been conducted to evaluate the efficacy of meningococcal polysaccharide vaccines against disease due to serogroups Y and W-135.

Menomune - A/C/Y/W-135 vaccine was used as the control vaccine in three US, multi-center, clinical trials designed primarily to evaluate the immunogenicity and safety of Menactra vaccine in children (2-10 years old), adolescents (11-18 years old), and adults (18-55 years old), respectively. In these trials, participants in the control arm received a dose of Menomune - A/C/Y/W-135 vaccine. Sera were obtained before and approximately 28 days after vaccination. The Serum Bactericidal Assay (SBA) used to test sera contained an exogenous complement source that was either human (SBA-H) or, when correlated to SBA-H, baby rabbit (SBA-BR).13

Data on immune responses, as measured by SBA-H, following Menomune - A/C/Y/W-135 vaccine in a subset of children 2-10 years old are presented in Table 3. Data on immune responses, as measured by SBA-BR, following Menomune - A/C/Y/W-135 vaccine in adolescents and adults are presented in Table 4.

Table 3: Bactericidal Antibody Responses* to Menomune - A/C/Y/W-135 Vaccine 28 Days After Vaccination for Subsets of Participants Aged 2-3 and 4-10 Years

MENOMUNE - A/C/Y/W-135 VACCINE AGED 2-3 YEARS 
N†=50-53
MENOMUNE - A/C/Y/W-135 VACCINE AGED 4-10 YEARS 
N†=84
SEROGROUP     (95% CI) ‡ SEROGROUP     (95% CI) J
A % ≥ 1:8 64 50,77 A % ≥ 1:8 55 44,66
GMT 10 7,12 GMT 7 6,9
C % ≥ 1:8 38 25,53 C % ≥ 1:8 48 37,59
GMT 11 5,21 GMT 12 7,18
Y % ≥ 1:8 73 59,84 Y % ≥ 1:8 92 84,97
GMT 18 11,27 GMT 46 33,66
W-135 % ≥ 1:8 33 20,47 W-135 % ≥ 1:8 79 68,87
GMT 5 3,6 GMT 20 14,27
The study was designed to show the safety and immunogenicity of Menactra vaccine are non-inferior to that of Menomune - A/C/Y/W-135 vaccine. The table shows the immune response in Menomune - A/C/Y /W-135 vaccine participants from this study.
* Serum Bactericidal Assay with an exogenous human complement (SBA-H) source.
† N = Number of subset participants with at least one valid serology result at Day 0 and Day 28.
‡ The 95% CI for the Geometric Mean Titer (GMT) was calculated based on an approximation to the normal distribution.

 

In participants 2-3 years of age with undetectable pre-vaccination SBA titers (ie, < 4 at Day 0), rates of seroconversion (defined as SBA titer ≥ 8 at Day 28) following Menomune - A/C/Y/W- 135 vaccine were 55%, serogroup A (n=16/29); 30%, serogroup C (n=13/43); 57%, serogroup Y (n=17/30); 26%, serogroup W-135 (n=11/43).

In participants 4-10 years of age with undetectable pre-vaccination SBA titers (ie, < 4 at Day 0), rates of seroconversion (defined as SBA titer ≥ 8 at Day 28) following Menomune - A/C/Y/W- 135 vaccine were 48%, serogroup A (n=10/21); 38%, serogroup C (n=19/50); 84%, serogroup Y (n=38/45); 68%, serogroup W-135 (n=26/38).

Table 4: Bactericidal Antibody Responses* to Menomune - A/C/Y/W-135 Vaccine 28 Days After Vaccination for Participants Aged 11-18 and 18-55 Years

View Enlarged Table

 

In participants 11-18 years of age with undetectable pre-vaccination SBA titers (ie, < 8 at Day 0), rates of seroconversion (defined as a ≥ 4-fold rise in Day 28 SBA titers) following Menomune - A/C/Y/W-135 vaccine were 100%, serogroup A (n=93/93); 99%, serogroup C (n=151/152); 100%, serogroup Y (n=47/47); 99%, serogroup W-135 (n=138/139).

In participants 18-55 years of age with undetectable pre-vaccination SBA titers (ie, < 8 at Day 0), rates of seroconversion (defined as a ≥ 4-fold rise in Day 28 SBA titers) following Menomune - A/C/Y/W-135 vaccine were 99%, serogroup A (n=143/144); 98%, serogroup C (n=297/304); 97%, serogroup Y (n=221/228); 99%, serogroup W-135 (n=325/328).

REFERENCES

6 Granoff DM, et al. Meningococcal vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008:399-434.

11 Makela PH, et al. Evolution of conjugate vaccines. Expert Rev Vaccines 2002;1(3):399- 410.

12 Goldschneider I, et al. Human immunity to the meningococcus. I. The Role of Humoral Antibodies. J Exp Med 1969;129:1307-1326.

13 Maslanka SE, et al. Standardization and a Multilaboratory Comparison of Neisseria meningitidis Serogroup A and C Serum Bactericidal Assays. Clin and Diag Lab Immunol 1997;156-167.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Before administration of Menomune - A/C/Y/W-135 vaccine, health-care providers should inform the patient, parent or guardian of the benefits and risks of the vaccine. The health-care provider should provide the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. Patients, parents, or guardians should be instructed to report adverse reactions to their health-care provider.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

MENINGOCOCCAL POLYSACCHARIDE VACCINE - SUBCUTANEOUS INJECTION

 

(men-in-JOE-coe-call paul-lee-SACK-car-ide)

 

COMMON BRAND NAME(S): Menomune

 

USES: This vaccine helps to protect high-risk patients against a certain type of serious bacterial infection that affects the brain and spinal cord (meningitis). This medication is also used to control an outbreak of this infection if it occurs. This vaccine does not protect you against all strains of this type of bacteria.

Vaccines work by causing the body to produce its own protection (antibodies). Enough antibodies to protect you are usually produced within 7-10 days after you receive this vaccine.

 

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

This vaccine is given by injection only under the skin (subcutaneously) by a healthcare professional.

You may need to have another dose of vaccine if you are still at high risk for infection 2-3 years after your last shot. Ask your doctor for more details.

This medication can be given at the same time as most other vaccines, using separate injection sites and separate syringes. However, it must not be given at the same time as whole-cell pertussis or typhoid vaccines.

Consumer Overview Side Effect

SIDE EFFECTS: Pain, redness, swelling, and tenderness at the injection site commonly occur and usually last 1-2 days. Headache and fever may also occur. Ask your doctor if you should take a fever/pain reducer (e.g., acetaminophen) to help treat these symptoms. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

 

Read the Menomune (meningococcal polysaccharide vaccine) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: See also How to Use and Drug Interactions sections.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the vial stopper), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: your vaccination/immunization history, recent illness or fever, immune system problems (e.g., due to cancer treatment, organ transplant, HIV).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more information.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used at the same time as whole-cell pertussis or typhoid vaccines because very serious interactions may occur.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cancer chemotherapy drugs, corticosteroids (e.g., dexamethasone, prednisone), drugs that weaken your immune system (e.g., cyclosporine, tacrolimus).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: It is important to understand the risks and benefits of vaccinations. Discuss this with your doctor.

 

MISSED DOSE: Not applicable.

 

STORAGE: Not applicable. This vaccine is given in a doctor's office and will not be stored at home.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Menomune A/C/Y/W-135

Generic Name: meningococcal polysaccharide vaccine (Pronunciation: me NIN je KOK al POL ee SAK a ride vax EEN)

  • What is meningococcal polysaccharide vaccine (Menomune)?
  • What are the possible side effects of this vaccine (Menomune)?
  • What is the most important information I should know about this vaccine (Menomune)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Menomune)?
  • How is this vaccine given (Menomune)?
  • What happens if I miss a dose (Menomune)?
  • What happens if I overdose (Menomune)?
  • What should I avoid before or after getting this vaccine (Menomune)?
  • What other drugs will affect this vaccine (Menomune)?
  • Where can I get more information?

What is meningococcal polysaccharide vaccine (Menomune)?

 

Meningococcal disease is a serious infection caused by a bacteria. Meningococcal bacteria can infect the blood, spinal cord, and brain. These conditions can be fatal.

Meningococcal disease can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The bacteria can also be passed through contact with objects the infected person has touched, such as a door handle, or other surface. The bacteria can also be passed through kissing, or sharing a drinking glass or eating utensil with an infected person.

Meningococcal polysaccharide vaccine is used to prevent infection caused by meningococcal bacteria. The vaccine contains four of the most common types of meningococcal bacteria.

Meningococcal polysaccharide vaccine works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes your body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Meningococcal polysaccharide vaccine is for use in adults and children who are at least 3 months of age.

Like any vaccine, meningococcal polysaccharide vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Menomune)?

 

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Developing meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
  • high fever; or
  • unusual bleeding.

Less serious side effects may include:

  • low fever, chills;
  • redness, pain, swelling, or a lump where the vaccine was injected;
  • headache; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the Menomune (meningococcal polysaccharide vaccine) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about this vaccine (Menomune)?

 

Developing meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another meningococcal vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Do not receive this vaccine if you have ever had an allergic reaction to a meningococcal vaccine, or if you are allergic to a preservative called thimerosol.

Before receiving meningococcal polysaccharide vaccine, tell your doctor if you have a weak immune system, if you are allergic to latex rubber, or if you are receiving steroids, chemotherapy, or radiation treatment. If you have any of these conditions, your vaccine may need to be postponed.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Like any vaccine, meningococcal polysaccharide vaccine may not provide protection from disease in every person.

Side Effects Centers
  • Menomune

Patient Detailed How Take

What should I discuss with my healthcare provider before receiving this vaccine (Menomune)?

 

You should not receive this vaccine if you have ever had an allergic reaction to a meningococcal vaccine, or if you are allergic to a preservative called thimerosol.

If you have any of these other conditions, your vaccine may need to be postponed or not given at all:

  • any condition that weakens the immune system (such as HIV, AIDS, or cancer);
  • if you are receiving steroids, chemotherapy, or radiation treatments; or
  • if you are allergic to latex rubber.

FDA pregnancy category C. It is not known whether meningococcal polysaccharide vaccine will harm an unborn baby. Tell your doctor if you are pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of this vaccine on the baby.

It is not known whether meningococcal polysaccharide vaccine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

This vaccine should not be given to anyone younger than 3 months old.

How is this vaccine given (Menomune)?

 

This vaccine is given as an injection under the skin. You will receive this injection in a doctor's office or clinic setting.

Meningococcal polysaccharide vaccine is usually given only once. Children and people who have higher risks of meningococcal infection may need a repeat dose of this vaccine 2 or 3 years after receiving the first shot.

Meningococcal polysaccharide vaccine is recommended in the following situations:

  • for people who do not have a spleen;
  • for laboratory workers who are routinely exposed to meningococcal bacteria;
  • for people who live in dormitories or other group housing; and
  • for people who travel or live among certain populations where meningococcal outbreak is common.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

Side Effects Centers
  • Menomune

Patient Detailed Avoid Taking

What happens if I miss a dose (Menomune)?

 

Since the meningococcal polysaccharide vaccine is usually given only once, you are not likely to miss a dose. Contact your doctor if you do not receive all recommended doses.

What happens if I overdose (Menomune)?

 

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after getting this vaccine (Menomune)?

 

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect this vaccine (Menomune)?

 

Before receiving this vaccine, tell your doctor if you are using a blood thinner (warfarin, Coumadin, Jantoven).

Tell your doctor about all other vaccines you have recently received. Meningococcal polysaccharide vaccine can be given at the same time as most other vaccinations, but should not be given together with a pertussis (whooping cough) or typhoid vaccine.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • azathioprine (Imuran);
  • basiliximab (Simulect);
  • cyclosporine (Sandimmune, Neoral, Gengraf);
  • etanercept (Enbrel);
  • leflunomide (Arava);
  • muromonab-CD3 (Orthoclone);
  • mycophenolate mofetil (CellCept);
  • sirolimus (Rapamune);
  • tacrolimus (Prograf);
  • chemotherapy or radiation treatment for cancer;
  • a steroid medicine such as betamethasone (Celestone), cortisone (Cortone), dexamethasone (Cortastat, Dexasone, Solurex), hydrocortisone (Cortef, Hydrocortone), methylprednisolone (Medrol), prednisolone (Orapred, Pediapred), prednisone (Meticorten, Sterapred), triamcinolone (Aristocort), and others; or
  • an inhaled or nasal steroid such as beclomethasone (Qvar, Beconase), budesonide (Pulmicort, Rhinocort, Symbicort), flunisolide (Aerobid, Nasarel), fluticasone (Advair, Flovent, Flonase, Veramyst), mometasone (Asmanex, Nasonex), or triamcinolone (Azmacort, Nasacort).

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete and other drugs may interact with meningococcal polysaccharide vaccine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.01. Revision date: 6/29/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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