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Menactra

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Menactra

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SIDE EFFECTS

Clinical Trials Experience

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.

Children 9 Through 12 Months of Age

The safety of Menactra vaccine was evaluated in four clinical studies that enrolled 3721 participants who received Menactra vaccine at 9 and 12 months of age. At 12 months of age these children also received one or more other recommended vaccines [Measles, Mumps, Rubella and Varicella Virus Vaccine Live (MMRV) or Measles, Mumps, and Rubella Virus Vaccine (MMR) and Varicella Virus Vaccine Live (V) each manufactured by Merck & Co., Inc., Pneumococcal 7- valent Conjugate Vaccine (Diphtheria CRM197 Protein) manufactured by Wyeth Pharmaceuticals Inc. (PCV7), Hepatitis A Vaccine manufactured by Merck & Co., Inc. (HepA). A control group of 997 children was enrolled at 12 months of age and received two or more childhood vaccines [MMRV (or MMR + V), PCV7, HepA] at 12 months of age [see Concomitant Vaccine Administration]. Three percent of individuals received MMR and V, instead of MMRV, at 12 months of age.

The primary safety study was a controlled trial that enrolled 1256 children who received Menactra vaccine at 9 and 12 months of age. At 12 months of age these children received MMRV (or MMR + V), PCV7 and HepA. A control group of 522 children received MMRV, PCV7 and HepA. Of the 1778 children, 78% of participants (Menactra vaccine, N=1056; control group, N=322) were enrolled at United States (US) sites and 22% at a Chilean site. (Menactra vaccine, N=200; control group, N=200).

Individuals 2 Through 55 Years of Age

The safety of Menactra vaccine was evaluated in eight clinical studies that enrolled 10,057 participants aged 2-55 years who received Menactra vaccine and 5,266 participants who received Menomune® - A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W- 135 Combined. There were no substantive differences in demographic characteristics between the vaccine groups. Among Menactra vaccine recipients 2-55 years of age 24.0%, 16.2%, 40.4% and 19.4% were in the 2-10, 11-14, 15-25 and 26-55-year age groups, respectively. Among Menomune - A/C/Y/W-135 vaccine recipients 2-55 years of age 42.3%, 9.3%, 30.0% and 18.5% were in the 2-10, 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 vaccine, N=1713; Menomune - A/C/Y/W-135 vaccine, N=1519), 11-18 years of age (Menactra vaccine, N=2270; Menomune - A/C/Y/W-135 vaccine, N=972) and 18-55 years of age (Menactra vaccine, N=1384; Menomune - A/C/Y/W-135 vaccine, N=1170), respectively. Of the 3232 children 2-10 years of age, 68% of participants (Menactra vaccine, N=1164; Menomune - A/C/Y/W-135 vaccine, N=1031) were enrolled at US sites and 32% (Menactra vaccine, N=549; Menomune - A/C/Y/W-135 vaccine, N=488) of participants at a Chilean site. The median ages in the Chilean and US subpopulations were 5 and 6 years, respectively. All adolescents and adults were enrolled at US sites. As the route of administration differed for the two vaccines (Menactra vaccine given intramuscularly, Menomune - A/C/Y/W-135 vaccine given subcutaneously), study personnel collecting the safety data differed from personnel administering the vaccine.

Safety Evaluation

Participants were monitored after each vaccination for 30 minutes for immediate reactions. Solicited injection site and systemic reactions were recorded in a diary card for 7 consecutive days after each vaccination. Participants were monitored for 28 days (30 days for infants and toddlers) 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.

Serious Adverse Events in All Safety Studies

Serious adverse events (SAEs) were reported during a 6-month time period following vaccinations in individuals 9 months through 55 years of age. In children who received Menactra vaccine at 9 months and at 12 months of age, SAEs occurred at a rate of 2.0% - 2.5%. In participants who received one or more childhood vaccine(s) (without co-administration of Menactra vaccine) at 12 months of age, SAEs occurred at a rate of 1.6% - 3.6%, depending on the number and type of vaccines received. In children 2-10 years of age, SAEs occurred at a rate of 0.6% following Menactra vaccine and at a rate of 0.7% following Menomune - A/C/Y/W-135 vaccine. In adolescents 11 through 18 years of age and adults 18 years through 55 years of age, SAEs occurred at a rate of 1.0% following Menactra 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 injection site and systemic adverse reactions within 7 days following vaccination in children 9 months and 12 months of age (Table 1) were injection site tenderness and irritability.

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

The most commonly reported solicited injection site and systemic adverse reactions in adolescents, ages 11-18 years (Table 3), and adults, ages 18-55 years (Table 4), were injection site pain, headache and fatigue. Except for redness in adults, injection site reactions were more frequently reported after Menactra vaccination than after Menomune - A/C/Y/W-135 vaccination.

Table 1: Percentage of US Participants Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration at 9 Months and 12 Months of Age

Reaction Menactra vaccine at 9 months of age Menactra + PCV7a+ MMRVb + HepAc vaccines at 12 months of age PCV7a+ MMRVb+ HepAc vaccines at 12 months of age
Nd=998 - 1002 Nd=898 - 908 Nd=302 - 307
Any Grade 2 Grade 3 Any Grade 2 Grade 3 Any Grade 2 Grade 3
Local/Injection Site
Tendernesse
  Menactra Site  37.4 4.3 0.6 48.5 7.5 1.3 - - -
  PCV7 Site - - - 45.6 9.4 1.6 45.7 8.3 0.3
  MMRV Site - - - 38.9 7.1 1.0 43.0 5.2 0.0
  HepA Site - - - 43.4 8.7 1.4 40.9 4.6 0.3
Erythemaf
  Menactra Site 30.2 2.5 0.3 30.1 1.3 0.1 - - -
  PCV7 Site - - - 29.4 2.6 0.2 32.6 3.0 0.7
  MMRV Site - - - 22.5 0.9 0.3 33.2 5.9 0.0
  HepA Site - - - 25.1 1.1 0.0 26.6 0.7 0.0
Swellingf
  Menactra Site 16.8 0.9 0.2 16.2 0.9 0.1 - - -
  PCV7 Site - - - 19.5 1.3 0.4 16.6 1.3 0.7
  MMRV Site - - - 12.1 0.4 0.1 14.1 0.3 0.0
  HepA Site - - - 16.4 0.7 0.2 13.5 0.0 0.3
Systemic
  Irritabilityg 56.8 23.1 2.9 62.1 25.7 3.7 64.8 28.7 4.2
  Abnormal cryingh 33.3 8.3 2.0 40.0 11.5 2.4 39.4 10.1 0.7
  Drowsinessi 30.2 3.5 0.7 39.8 5.3 1.1 39.1 5.2 0.7
  Appetite lossj 30.2 7.1 1.2 35.7 7.6 2.6 31.9 6.5 0.7
  Vomitingk 14.1 4.6 0.3 11.0 4.4 0.2 9.8 2.0 0.0
  Feverl 12.2 4.5 1.1 24.5 11.9 2.2 21.8 7.3 2.6
a PCV7 (Prevnar®) = Pneumococcal 7-valent Conjugate Vaccine
bMMRV (ProQuad®) = Measles, Mumps, Rubella and Varicella Virus Vaccine Live
c HepA (VAQTA®) = Hepatitis A Vaccine, Inactivated
d N = The number of subjects with available data.
e Grade 2: cries and protests when injection site is touched, Grade 3: cries when injected limb is moved, or the movement of the injected limb is reduced.
f Grade 2: > 1.0 inches to < 2.0 inches, Grade 3: > 2.0 inches.
g Grade 2: requires increased attention, Grade 3: inconsolable.
h Grade 2: 1 to 3 hours, Grade 3: > 3 hours.
I Grade 2: not interested in surroundings or did not wake up for a feed/meal, Grade 3: sleeping most of the time or difficult to wake up.
J Grade 2: missed 1 or 2 feeds/meals completely, Grade 3: refuses > 3 feeds/meals or refuses most feeds/meals.
k Grade 2: 2 to 5 episodes per 24 hours, Grade 3: > 6 episodes per 24 hours or requiring parenteral hydration.
l Grade 2: > 38.5°C to < 39.5°C, Grade 3: > 39.5°C.

Table 2: Percentage of US Participants 2 Years Through 10 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration

Reaction Menactra vaccine
Na=1156 - 1157
Menomune - A/C/Y/W-135 vaccine
Na=1027
Any Grade 2 Grade 3 Any Grade 2 Grade 3
Local/Injection Site
  Painb 45.0 4.9 0.3 26.1 2.5 0.0
  Rednessc 21.8 4.6 3.9 7.9 0.5 0.0
  Indurationc 18.9 3.4 1.4 4.2 0.6 0.0
  Swellingc 17.4 3.9 1.9 2.8 0.3 0.0
Systemic
  Irritabilityd 12.4 3.0 0.3 12.2 2.6 0.6
  Diarrheae 11.1 2.1 0.2 11.8 2.5 0.3
  Drowsinessf 10.8 2.7 0.3 11.2 2.5 0.5
  Anorexiag 8.2 1.7 0.4 8.7 1.3 0.8
  Arthralgiah 6.8 0.5 0.2 5.3 0.7 0.0
  Feveri 5.2 1.7 0.3 5.2 1.7 0.2
  Rashj 3.4 - - 3.0 - -
  Vomitingk 3.0 0.7 0.3 2.7 0.7 0.6
  Seizurel 0.0 - - 0.0 - -
a N = The total number of subjects reporting at least one solicited reaction. The median age of participants was 6 years in both vaccine groups.
b Grade 2: interferes with normal activities, Grade 3: disabling, unwilling to move arm.
c Grade 2: 1.0-2.0 inches, Grade 3: > 2.0 inches.
d Grade 2: 1-3 hours duration, Grade 3: > 3 hours duration.
e Grade 2: 3-4 episodes, Grade 3: ≥ 5 episodes.
f Grade 2: interferes with normal activities, Grade 3: disabling, unwilling to engage in play or interact with others.
g Grade 2: skipped 2 meals, Grade 3: skipped ≥ 3 meals.
h Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unable to move major joints due to pain.
i Oral equivalent temperature; Grade 2: 38.4°C to 39.4°C, Grade 3: ≥ 39.5°C.
j These solicited adverse events were reported as present or absent only.
k Grade 2: 2 episodes, Grade 3: ≥ 3 episodes.
Note: During the study Grade 1, Grade 2, and Grade 3 were collected as Mild, Moderate, and Severe respectively.

Table 3: Percentage of Participants 11 Years Through 18 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration

Reaction Menactra vaccine
Na=2264 - 2265
Menomune - A/C/Y/W-135 vaccine
Na=970
Any Grade 2 Grade 3 Any Grade 2 Grade 3
Local/Injection Site
  Painb 59.2c 12.8c 0.3 28.7 2.6 0.0
  Indurationd 15.7c 2.5c 0.3 5.2 0.5 0.0
  Rednessd 10.9c 1.6c 0.6c 5.7 0.4 0.0
  Swellingd 10.8c 1.9c 0.5c 3.6 0.3 0.0
Systemic
  Headachee 35.6c 9.6c 1.1 29.3 6.5 0.4
  Fatiguee 30.0c 7.5 1.1c 25.1 6.2 0.2
  Malaisee 21.9c 5.8c 1.1 16.8 3.4 0.4
  Arthralgiae 17.4c 3.6c 0.4 10.2 2.1 0.1
  Diarrheaf 12.0 1.6 0.3 10.2 1.3 0.0
  Anorexiag 10.7c 2.0 0.3 7.7 1.1 0.2
  Chillse 7.0c 1.7c 0.2 3.5 0.4 0.1
  Feverh 5.1 c 0.6 0.0 3.0 0.3 0.1
  Vomitingi 1.9 0.4 0.3 1.4 0.5 0.3
  Rashj 1.6 - - 1.4 - -
  Seizurej 0.0 - - 0.0 - -
a N = The number of subjects with available data.
b Grade 2: interferes with or limits usual arm movement, Grade 3: disabling, unable to move arm.
c Denotes p < 0.05 level of significance. The p-values were calculated for each category and severity using Chi Square test.
d Grade 2: 1.0-2.0 inches, Grade 3: > 2.0 inches.
e Grade 2: interferes with normal activities, Grade 3: requiring bed rest.
f Grade 2: 3-4 episodes, Grade 3: ≥ 5 episodes.
g Grade 2: skipped 2 meals, Grade 3: skipped ≥ 3 meals.
h Oral equivalent temperature; Grade 2: 38.5°C to 39.4°C, Grade 3: ≥ 39.5°C.
i Grade 2: 2 episodes, Grade 3: ≥ 3 episodes.
j These solicited adverse events were reported as present or absent only.
Note: During the study Grade 1, Grade 2, and Grade 3 were collected as Mild, Moderate, and Severe respectively.

Table 4: Percentage of Participants 18 Years Through 55 Years of Age Reporting Solicited Adverse Reactions Within 7 Days Following Vaccine Administration

Reaction Menactra vaccine
Na=1371
Menomune - A/C/Y/W-135 vaccine
Na=1159
Any Grade 2 Grade 3 Any Grade 2 Grade 3
Local/Injection Site
Painb 53.9c 11.3c 0.2 48.1 3.3 0.1
Indurationd 17.1c 3.4c 0.7c 11.0 1.0 0.0
Rednessd 14.4 2.9 1.1c 16.0 1.9 0.1
Swellingd 12.6c 2.3c 0.9c 7.6 0.7 0.0
Systemic
Headachee 41.4 10.1 1.2 41.8 8.9 0.9
Fatiguee 34.7 8.3 0.9 32.3 6.6 0.4
Malaise e 23.6 6.6c 1.1 22.3 4.7 0.9
Arthralgiae 19.8c 4.7c 0.3 16.0 2.6 0.1
Diarrheaf 16.0 2.6 0.4 14.0 2.9 0.3
Anorexiag 11.8 2.3 0.4 9.9 1.6 0.4
Chillse 9.7c 2.1c 0.6c 5.6 1.0 0.0
Vomitingh 2.3 0.4 0.2 1.5 0.2 0.4
Feveri 1.5c 0.3 0.0 0.5 0.1 0.0
Rashj 1.4 - - 0.8 - -
Seizurej 0.0 - - 0.0 - -
a N = The number of subjects with available data.
b Grade 2: interferes with or limits usual arm movement, Grade 3: disabling, unable to move arm.
c Denotesp < 0.05 level of significance. The p-values were calculated for each category and severity using Chi Square test.
d Grade 2: 1.0-2.0 inches, Grade 3: > 2.0 inches.
e Grade 2: interferes with normal activities, Grade 3: requiring bed rest.
f Grade 2: 3-4 episodes, Grade 3: ≥ 5 episodes.
g Grade 2: skipped 2 meals, Grade 3: skipped ≥ 3 meals.
h Grade 2: 2 episodes, Grade 3: ≥ 3 episodes.
i Oral equivalent temperature; Grade 2: 39.0°C to 39.9°C, Grade 3: ≥ 40.0°C.
j These solicited adverse events were reported as present or absent only.
Note: During the study Grade 1, Grade 2, and Grade 3 were collected as Mild, Moderate, and Severe respectively.

Adverse Events in Concomitant Vaccine Studies

Solicited Injection site and Systemic Reactions when Given with Routine Pediatric Vaccines

For a description of the study design and number of participants [see Clinical Studies, Concomitant Vaccine Administration]. In the primary safety study, 1378 US children were enrolled to receive Menactra vaccine alone at 9 months of age and Menactra vaccine plus one or more other routinely administered vaccines (MMRV, PCV7 and HepA) at 12 months of age (N=961). Another group of children received two or more routinely administered vaccines (MMRV, PCV7 and HepA vaccines) (control group, n=321) at 12 months of age. The frequency of occurrence of solicited adverse events is presented in Table 1. Participants who received Menactra vaccine and the concomitant vaccines at 12 months of age described above reported similar frequencies of tenderness, redness and swelling at the Menactra vaccine injection site and at the concomitant vaccine injection sites. Tenderness was the most frequent injection site reaction (48%, 39%, 46% and 43% at the Menactra vaccine, MMRV, PCV7 and HepA vaccine sites, respectively). Irritability was the most frequent systemic reaction, reported in 62% of recipients of Menactra vaccine plus concomitant vaccines, and 65% of control group. [See Concomitant Vaccine Administration].

Solicited Injection site and Systemic Reactions when Given with Tetanus and Diphtheria Toxoid Adsorbed Vaccine

In a clinical study, rates of local and systemic reactions after Menactra vaccine and Tetanus and Diphtheria Toxoid Adsorbed (Td) vaccine manufactured by Sanofi Pasteur Inc. were compared [see DRUG INTERACTIONS, and Concomitant Vaccine Administration for study description]. Injection site pain was reported more frequently after Td vaccination than after Menactra vaccination (71% versus 53%). The overall rate of systemic adverse events was higher when Menactra and Td vaccines were given concomitantly than when Menactra vaccine was administered 28 days after Td (59% versus 36%). In both groups, the most common reactions were headache (Menactra vaccine + Td, 36%; Td + Placebo, 34%; Menactra vaccine alone, 22%) and fatigue (Menactra vaccine + Td, 32%; Td + Placebo, 29%; Menactra vaccine alone, 17%). Fever ≥ 40.0°C occurred at ≤ 0.5% in all groups.

Solicited Injection site and Systemic Reactions when Given with Typhoid Vi Polysaccharide Vaccine

In a clinical study, rates of local and systemic reactions after Menactra vaccine and Typhoid Vi Polysaccharide Vaccine, produced by Sanofi Pasteur SA were compared [see DRUG INTERACTIONS, Concomitant Vaccine Administration] for a description of the concomitantly administered vaccine, study design and number of participants. More participants experienced pain after Typhoid vaccination than after Menactra vaccination (Typhoid + Placebo, 76% versus Menactra vaccine + Typhoid, 47%). The majority (70%-77%) of injection site solicited reactions for both groups at either injection site were reported as Grade 1 and resolved within 3 days postvaccination. In both groups, the most common systemic reaction was headache (Menactra vaccine + Typhoid, 41%; Typhoid + Placebo, 42%; Menactra vaccine alone, 33%) and fatigue (Menactra vaccine + Typhoid, 38%; Typhoid + Placebo, 35%; Menactra vaccine alone, 27%). Fever > 40.0°C and seizures were not reported in either group.

Post-Marketing Experience

In addition to reports in clinical trials, worldwide voluntary adverse events reports received since market introduction of Menactra vaccine are listed below. This list includes serious events and/or events which were included based on severity, frequency of reporting or a plausible causal connection to Menactra vaccine. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination.

Post-marketing Safety Study

The risk of GBS following receipt of Menactra vaccine was evaluated in a US retrospective cohort study using healthcare claims data from 9,578,688 individuals 11 through 18 years of age, of whom 1,431,906 (15%) received Menactra vaccine. Of 72 medical chart-confirmed GBS cases, none had received Menactra vaccine within 42 days prior to symptom onset. An additional 129 potential cases of GBS could not be confirmed or excluded due to absent or insufficient medical chart information. In an analysis that took into account the missing data, estimates of the attributable risk of GBS ranged from 0 to 5 additional cases of GBS per 1,000,000 vaccinees within the 6 week period following vaccination.

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

DRUG INTERACTIONS

Concomitant Administration with Other Vaccines

Menactra vaccine was concomitantly administered with Typhim Vi® [Typhoid Vi Polysaccharide Vaccine] (Typhoid) and Tetanus and Diphtheria Toxoids Adsorbed, For Adult Use (Td), in individuals 18 through 55 and 11 through 17 years of age, respectively. In children younger than 2 years of age, Menactra was co-administered with one or more of the following vaccines: PCV7, MMR, V, MMRV, or HepA vaccine [see Clinical Studies and ADVERSE REACTIONS].

Data are not available to assess the safety and immunogenicity of Menactra and DTaP containing vaccines when administered concomitantly at 15 months of age.

Pneumococcal antibody responses to some serotypes in PCV7 were decreased following coadministration of Menactra vaccine and PCV7 [see Concomitant Vaccine Administration].

Do not mix Menactra vaccine with other vaccines in the same syringe. When Menactra vaccine is administered concomitantly with other injectable vaccines, the vaccines should be administered with different syringes and given at separate injection sites.

Immunosuppressive Therapies

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

Last reviewed on RxList: 9/12/2014
This monograph has been modified to include the generic and brand name in many instances.

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