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Menomune

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Menomune

Side Effects
Interactions

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

DRUG 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

Last reviewed on RxList: 9/18/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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