Recommended Topic Related To:

Menactra

"A unique type of poster placed in exam rooms helped reduce unnecessary antibiotic prescriptions for respiratory infections during flu season. The approach could help reduce costs and extend the usefulness of these drugs.

Antibiotics a"...

Menactra

Menactra

SIDE EFFECTS

The safety of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine was evaluated in 8 clinical studies that enrolled 10,057 participants aged 2-55 years who received Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and 5266 participants who received Menomune-A/C/Y/W-135 vaccine. There were no substantive differences in demographic characteristics between the vaccine groups. Among Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine recipients of all ages, 24.0%, 16.2%, 40.4% and 19.4% were in the 2-10 year age range, 11-14, 15-25 and 26-55-year age groups, respectively. Among Menomune-A/C/Y/W-135 vaccine recipients of all ages, 42.3%, 9.3%, 30.0% and 18.5% were in the 2-10 year age range, 11-14, 15-25 and 26-55-year age groups, respectively.

The three primary safety studies were randomized, active-controlled trials that enrolled participants 2-10 years of age (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine, N=1713; Menomune-A/C/Y/W-135 vaccine, N=1519), 11-18 years of age (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine, N=2270; Menomune-A/C/Y/W-135 vaccine, N=972) and 18-55 years of age (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine, N=1384; Menomune-A/C/Y/W-135 vaccine, N=1170), respectively. Of the 3232 children 2-10 years old, 68% of participants (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine, n=1164; Menomune-A/C/Y/W-135 vaccine, n=1031) were enrolled at US sites, and 32% of participants at a Chilean site. The median ages in the Chilean and US subpopulations were 5 and 6 years old, respectively. All adolescents and adults were enrolled at US sites. As the route of administration differed for the two vaccines (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine given intramuscularly, Menomune-A/C/Y/W-135 vaccine given subcutaneously), study personnel collecting the safety data differed from personnel administering the vaccine. Solicited local and systemic reactions were monitored daily for 7 days post- vaccination using a diary card. Participants were monitored for 28 days for unsolicited adverse events and for 6 months post-vaccination for visits to an emergency room, unexpected visits to an office physician, and serious adverse events. Unsolicited adverse event information was obtained either by telephone interview or at an interim clinic visit. Information regarding adverse events that occurred in the 6-month post-vaccination time period was obtained via a scripted telephone interview. At least 94% of participants from the three primary studies completed the 6-month follow-up evaluation.

In the two concomitant vaccination studies with Menactra (polysaccharide diphtheria toxoid conjugate vaccine) and either Typhim Vi or Td vaccines, local and systemic adverse events were monitored for 7 days post-vaccination using a diary card. Serious adverse events occurring within 1 month after each vaccination were reported and recorded.

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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.

Serious Adverse Events in All Safety Studies

Serious adverse events reported within a 6-month time period following vaccination in children 2-10 years old occurred at a rate of 0.6% following Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and at a rate of 0.7% following Menomune-A/C/Y/W-135 vaccine. Serious adverse events reported within a 6-month time period following vaccination in adolescents and adults occurred at a rate of 1.0% following Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine and at a rate of 1.3% following Menomune-A/C/Y/W-135 vaccine.

Solicited Adverse Events in the Primary Safety Studies

The most frequently reported solicited local and systemic adverse reactions in US children aged 2-10 years (Table 7) were injection site pain and irritability. Diarrhea, drowsiness, and anorexia were also common.

The most commonly reported solicited local and systemic adverse reactions in adolescents, ages 11-18 years (Table 8), and adults, ages 18-55 years (Table 9), were injection site pain, headache and fatigue. Except for redness in adults, local reactions were more frequently reported after Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccination than after Menomune-A/C/Y/W-135 vaccination. The majority of local and systemic reactions following Menactra (polysaccharide diphtheria toxoid conjugate vaccine) or Menomune-A/C/Y/W-135 vaccination were reported as mild in intensity. Between the vaccine groups, differences in rates of malaise, diarrhea, anorexia, vomiting, or rash, including urticaria were not statistically significant.

Table 7:  Percentage of US Participants 2-10 Years of Age Reporting Solicited Adverse ReactionsWithin 7 Days Following Vaccine Administration

  Menactra vaccine
*N=1157
Menomune - A/C/Y/W-135 vaccine
*N=1027
Reaction Any Moderate Severe Any Moderate Severe
Redness 21.8 4.6 3.9 7.9 0.5 0.0
Swelling 17.4 3.9 1.9 2.8 0.3 0.0
Induration 18.9 3.4 1.4 4.2 0.6 0.0
Pain‡ 45.0 4.9 0.3 26.1 2.5 0.0
Drowsiness 10.8 2.7 0.3 11.2 2.5 0.5
Irritability|| 12.4 3.0 0.3 12.2 2.6 0.6
Arthralgia¶ 6.8 0.5 0.2 5.3 0.7 0.0
Diarrhea# 11.1 2.1 0.2 11.8 2.5 0.3
Anorexia** 8.2 1.7 0.4 8.7 1.3 0.8
Fever†† 5.2 1.7 0.3 5.2 1.7 0.2
Vomiting‡‡ 3.0 0.7 0.3 2.7 0.7 0.6
Rash§§ 3.4     3.0    
Seizure§§ 0.0     0.0    
*    N = The total number of subjects reporting at least one solicited reaction. The median age of participants was 6 years in both vaccine groups.
†  Moderate: 1.0-2.0 inches, Severe: > 2.0 inches.
‡ Moderate: interferes with normal activities, Severe: disabling, unwilling to move arm.
§ Moderate: interferes with normal activities, Severe: disabling, unwilling to engage in play or interact with others.
|| Moderate: 1-3 hours duration, Severe: > 3 hours duration.
¶ Moderate: Decreased range of motion due to pain or discomfort, Severe: unable to move major joints due to pain.
#    Moderate: 3-4 episodes, Severe: ≥ 5 episodes
.** Moderate: Skipped 2 meals, Severe: skipped =3 meals.
†† Oral equivalent temperature; Moderate: 38.4-39.4ºC, Severe: =39.5ºC.
‡‡ Moderate: 2 episodes, Severe: =3 episodes.
§§ These solicited adverse events were reported as present or absent only.

Table 8: Percentage of Participants 11-18 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration

  Menactra vaccine
N*=2264
Menomune - A/C/Y/W-135 vaccine
N*=970
Reaction Any Moderate Severe Any Moderate Severe
Redness‡ 10.9† 1.6† 0.6† 5.7 0.4 0.0
Swelling‡ 10.8† 1.9† 0.5† 3.6 0.3 0.0
Induration‡ 15.7† 2.5† 0.3 5.2 0.5 0.0
Pain§ 59.2† 12.8† 0.3 28.7 2.6 0.0
Headache|| 35.6† 9.6† 1.1 29.3 6.5 0.4
Fatigue|| 30.0† 7.5 1.1† 25.1 6.2 0.2
Malaise|| 21.9† 5.8† 1.1 16.8 3.4 0.4
Arthralgia|| 17.4† 3.6† 0.4 10.2 2.1 0.1
Diarrhea¶ 12.0 1.6 0.3 10.2 1.3 0.0
Anorexia# 10.7† 2.0 0.3 7.7 1.1 0.2
Chills|| 7.0† 1.7† 0.2 3.5 0.4 0.1
Fever** 5.1† 0.6 0.0 3.0 0.3 0.1
Vomiting†† 1.9 0.4 0.3 1.4 0.5 0.3
Rash‡‡ 1.6     1.4    
Seizure‡‡ 0.0     0.0    
*    N = The number of subjects with available data.
† Denotes p < 0.05 level of significance. The p values were calculated for each category and severity using Chi Square test.
‡ Moderate: 1.0-2.0 inches, Severe: > 2.0 inches.
§ Moderate: Interferes with or limits usual arm movement, Severe: Disabling, unable to move arm.
|| Moderate: Interferes with normal activities, Severe: Requiring bed rest.
¶ Moderate: 3-4 episodes, Severe: ≥ 5 episodes.
#   Moderate: Skipped 2 meals, Severe: Skipped ≥ 3 meals.
** Oral equivalent temperature; Moderate: 38.5-39.4ºC, Severe: ≥ 39.5ºC.
†† Moderate: 2 episodes, Severe: ≥ 3 episodes.
‡‡ These solicited adverse events were reported as present or absent only.

Table 9: Percentage of Participants 18-55 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration

  Menactra vaccine N*=1371   Menomune - A/C/Y/W-135 vaccine N*=1159
Reaction Any Moderate Severe Any Moderate Severe
Redness‡ 14.4 2.9 1.1† 16.0 1.9 0.1
Swelling‡ 12.6† 2.3† 0.9† 7.6 0.7 0.0
Induration‡ 17.1† 3.4† 0.7† 11.0 1.0 0.0
Pain§ 53.9† 11.3† 0.2 48.1 3.3 0.1
Headache|| 41.4 10.1 1.2 41.8 8.9 0.9
Fatigue|| 34.7 8.3 0.9 32.3 6.6 0.4
Malaise|| 23.6 6.6† 1.1 22.3 4.7 0.9
Arthralgia|| 19.8† 4.7† 0.3 16.0 2.6 0.1
Diarrhea¶ 16.0 2.6 0.4 14.0 2.9 0.3
Anorexia# 11.8 2.3 0.4 9.9 1.6 0.4
Chills|| 9.7† 2.1† 0.6† 5.6 1.0 0.0
Fever** 1.5† 0.3 0.0 0.5 0.1 0.0
Vomiting†† 2.3 0.4 0.2 1.5 0.2 0.4
Rash‡‡ 1.4     0.8    
Seizure‡‡ 0.0     0.0    
* N = The number of subjects with available data.
† Denotes . <0.05 level of significance. The p values were calculated for each category and severity using Chi Square test.
‡ Moderate: 1.0-2.0 inches, Severe: >2.0 inches.
§ Moderate: Interferes with or limits usual arm movement, Severe: Disabling, unable to move arm.
|| Moderate: Interferes with normal activities, Severe: Requiring bed rest.
¶ Moderate: 3-4 episodes, Severe: =5 episodes.
# Moderate, Skipped 2 meals, Severe: Skipped =3 meals.
** Oral equivalent temperature; Moderate: 39.0-39.9ºC, Severe: = 40.0ºC.
†† Moderate: 2 episodes, Severe: =3 episodes.
‡‡ These solicited adverse events were reported as present or absent only.

Adverse Events in Concomitant Vaccine Studies

Local and Systemic Reactions when Given with Td Vaccine

See Concomitant Vaccine Administration section for a description of the study design and number of participants. The two vaccine groups reported similar frequencies of pain, induration, redness and swelling at the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) injection site, as well as, at the Td injection site. Pain was the most frequent local reaction reported at both the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) and Td injection sites. More participants experienced pain after Td vaccination than after Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccination (71% versus 53%). The majority (66%-77%) of local solicited reactions for both groups at either injection site were reported as mild and resolved within 3 days post-vaccination.

The overall rate of systemic adverse events was higher when Menactra (polysaccharide diphtheria toxoid conjugate vaccine) and Td vaccines were given concomitantly than when Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine was administered 28 days after Td. In both groups, the most common reactions were headache (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine + Td, 36%; Td + Placebo, 34%; Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine alone, 22%) and fatigue (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine + Td, 32%; Td + Placebo, 29%; Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine alone, 17%). Between the groups, differences in rates of malaise, diarrhea, anorexia, vomiting, or rash were not statistically significant. Fever ≥ 40.0ºC occurred at ≤ 0.5% in all groups. No seizures occurred in either group.

Local and Systemic Reactions when Given with Typhim Vi Vaccine

See Concomitant Vaccine Administration section for a description of the study design and number of participants. The two vaccine groups reported similar frequencies of pain, induration, redness and swelling at the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) injection site, as well as, at the Typhim Vi injection site. Pain was the most frequent local reaction reported at both the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) and Typhim Vi injection sites. More participants experienced pain after Typhim Vi vaccination than after Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccination (76% versus 47%). The majority (70%-77%) of local solicited reactions for both groups at either injection site were reported as mild and resolved within 3 days post-vaccination. In both groups, the most common systemic reaction was headache (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) + Typhim Vi vaccine, 41%; Typhim Vi vaccine + Placebo, 42%; Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine alone, 33%) and fatigue (Menactra (polysaccharide diphtheria toxoid conjugate vaccine) + Typhim Vi vaccine, 38%; Typhim Vi vaccine + Placebo, 35%; Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine alone, 27%). Between the groups, differences in rates of malaise, diarrhea, anorexia, or vomiting were not statistically significant. Fever ≥ 40.0ºC and seizures were not reported in either group.

Post-Marketing Reports

The following adverse events have been reported during post-approval use of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine. Because these events were reported voluntarily from a population of uncertain size, it is not always possible to reliably calculate their frequency or to establish a causal relationship to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine exposure.

Nervous system disorders - Guillain-Barre syndrome, vasovagal syncope, facial palsy, transverse myelitis, acute disseminated encephalomyelitis Skin and subcutaneous tissue disorders - Urticaria Musculoskeletal and connective tissue disorders - Myalgia

Reporting of Adverse Events

Vaccine Adverse Event Reporting System (VAERS) was established by the US Department of Health and Human Services to accept all reports of suspected adverse events after the administration of any vaccine. Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967 or through http://vaers.hhs.gov.18 Reporting to VAERS of all adverse events after vaccination by parents, guardians or adult patients should be encouraged.

Health-care providers should also report these events to Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1- 800-822-2463.

Read the Menactra (polysaccharide diphtheria toxoid conjugate vaccine) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

For information regarding concomitant administration of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine with other vaccines, refer to CLINICAL PHARMACOLOGY, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections.

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses) may reduce the immune response to vaccines.

REFERENCES

18. CDC. Vaccine Adverse Event Reporting System - United States. MMWR 1990;39:730-733.

Last reviewed on RxList: 10/30/2007
This monograph has been modified to include the generic and brand name in many instances.

A A A

Menactra - User Reviews

Menactra User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Menactra sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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.


Women's Health

Find out what women really need.

Related Drugs
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations