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Vaccine Information: MENOMUNE – A/C/Y/W-135 COMBINED

MENOMUNE — A/C/Y/W-135 COMBINED- neisseria meningitidis group a capsular polysaccharide antigen, neisseria meningitidis group c capsular polysaccharide antigen, neisseria meningitidis group y capsular polysaccharide antigen, and neisseria meningitidis group w-135 capsular polysaccharide antigen
Sanofi Pasteur Inc.

1. INDICATIONS AND USAGE

Menomune® – A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, is indicated for active immunization for 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.

2. DOSAGE AND ADMINISTRATION

2.1. 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 and aseptic 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 Use a separate sterile needle and syringe and aseptic technique for each dose withdrawn from the multidose vial.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

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

Figure 1

Figure 2

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

Figure 2

Figure 3

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

Figure 3

Figure 4

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.

Figure 4

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 (16.2).]

2.2. 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)

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.

3. 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 (2.1)]. After reconstitution, each dose consists of a 0.5 mL solution for injection. See Description (11) for the complete listing of ingredients.

4. CONTRAINDICATIONS

4.1. 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 (11)].

5. WARNINGS AND PRECAUTIONS

5.1. 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.

5.2. Management of Acute Allergic Reactions

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

5.3. Moderate or Severe Acute Illness

To avoid diagnostic confusion between manifestations of an acute illness and 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)

5.4. Limitations of Vaccine Effectiveness

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

5.5. Altered Immunocompetence

Persons who are immunosuppressed, including persons receiving immunosuppressive therapy, may have a diminished immune response to Menomune – A/C/Y/W-135 vaccine [see Drug Interactions (7)].

6. ADVERSE REACTIONS

6.1. 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 2-10 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 Events 1

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
N=1019-1027*
Event Any Moderate Severe
% % %
*
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: 38.4-39.4ºC, Severe: ≥39.5ºC.
Moderate: Skipped 2 meals, Severe: skipped ≥3 meals.
#
Moderate: 2 episodes, Severe: ≥3 episodes.
Þ
Moderate: 3-4 episodes, Severe: ≥5 episodes.
ß
Moderate: Interferes with normal activities, Severe: disabling, unwilling to engage in play or interaction with others.
à
Moderate: 1-3 hours duration, Severe: >3 hours duration.
è
These solicited adverse events were reported as present or absent only.
ð
Moderate: Decreased range of motion due to pain or discomfort, Severe: unable to move major joints because of pain.
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 Þ 11.8 2.5 0.3
Nervous system disorders
Drowsiness ß 11.2 2.5 0.5
Irritability à 12.2 2.6 0.6
Seizures è 0.0 N/A N/A
Musculoskeletal and connective tissue disorders
Arthralgia ð 5.3 0.7 0.0
Skin and subcutaneous disorders
Rash è 3.0 N/A N/A
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
Study 1N *=970 Study 2N *=1159
Participants 11-18 years of age Participants 18-55 years of age
Event Any Moderate Severe Any Moderate Severe
*
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: 38.5-39.4ºC, Severe: ≥39.5ºC. Study 2: Moderate 39.0-39.9ºC, Severe: ≥40.0ºC.
#
Moderate: 3-4 episodes, Severe: ≥5 episodes.
Þ
Moderate: Skipped 2 meals, Severe: skipped ≥3 meals.
ß
Moderate: 2 episodes, Severe: ≥3 episodes.
à
Moderate: discomforting enough to interfere with activities, Severe: disabling requires bed rest and analgesics.
è
These solicited adverse events were reported as present or absent only.
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 Þ 7.7 1.1 0.2 9.9 1.6 0.4
Vomiting ß 1.4 0.5 0.3 1.5 0.2 0.4
Nervous system disorders
Headache à 29.3 6.5 0.4 41.8 8.9 0.9
Seizure è 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 è 1.4 N/A N/A 0.8 N/A N/A
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