You will receive this injection in a doctor's office or clinic setting.you have been exposed to an outbreak of meningococcal disease;you work in a laboratory and are exposed to meningococcal bacteria;you live in or travel to an area where meningococcal disease is common;you have a medical problem affecting your spleen, or your spleen has been removed;you have an immune system disorder called "persistent complement component deficiency. Participants received a single dose of Menactra (N=2526) or Menomune – A/C/Y/W-135 (N=2317). This means the Food and Drug Administration licensed them to provide protection against 1 serogroup (B).
The seroconversion rates for Menomune – A/C/Y/W-135 recipients 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).Results from the comparative clinical trial conducted in 881 adolescents aged 11 through 18 years showed that the immune responses to Menactra and Menomune – A/C/Y/W-135 were similar for all four serogroups (Table 7).In participants with undetectable pre-vaccination titers (ie, SBA-BR titers <1:8 at Day 0), seroconversion rates (defined as the proportions of participants achieving a ≥4-fold rise in SBA-BR titers by Day 28) were similar between the Menactra and Menomune – A/C/Y/W-135 recipients.

For all participants, sera were obtained approximately 30 days after last vaccination. Menactra participants achieved seroconversion rates of: 57%, Serogroup A (n=12/21); 62%, Serogroup C (n=29/47); 84%, Serogroup Y (n=26/31); 53%, Serogroup W-135 (n=20/38). Of these reports, 87 had known pregnancy outcomes available and were enrolled in the pregnancy registry prior to the outcomes being known.

Package Insert - VAQTA; Supporting Documents.



The risk of GBS following Menactra vaccination was evaluated in a post-marketing retrospective cohort study [see Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. There were no substantive differences in demographic characteristics between the vaccine groups. Solicited injection site and systemic reactions were recorded in a diary card for 7 consecutive days after each vaccination. The proportions of participants with a 4-fold or greater increase in SBA-BR titer to meningococcal Serogroups C, Y and W-135 were higher when Menactra was given concomitantly with Td vaccine (86%-96%) than when Menactra was given one month following Td vaccine (65%-91%). The manufacturer has sent letters to health-care providers and is Meningococcal conjugate vaccine contains four of the most common types of meningococcal bacteria (serogroups A, C, W, and Y).

the United States (Prelicensure studies conducted by Sanofi Pasteur of approximately 7,000 recipients of MCV4 revealed no GBS cases Do not use after the expiration date.Vaccine Information Statements are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization to the patient, parent, or guardian. Frozen/previously frozen product should not be used. An ongoing known risk for serious reported another acute illness before onset of neurologic symptoms. If any of these conditions exist, the vaccine should not be administered.Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a sterile needle and syringe.Menactra is administered as a 0.5 mL dose by intramuscular injection. Menactra is approved for use in individuals 9 months through 55 years of age. CSF examination revealed 5 be submitted to VAERS at * Military recruits, travelers to areas in which meningococcal disease is hyperendemic or epidemic, microbiologists who are routinely exposed to isolates of The animals were administered 0.1 mL of Menactra (in divided doses) at each of the following time points: 14 days prior to mating, and on Days 6 and 18 of gestation (a single human dose is 0.5 mL). vaccines (UK Department of Health, unpublished data, 2005). (Menactra, N=200; control group, N=200).The safety of Menactra was evaluated in eight clinical studies that enrolled 10,057 participants aged 2-55 years who received Menactra and 5,266 participants who received MenomuneIn an open-label trial conducted in the US, 834 individuals were enrolled to receive a single dose of Menactra 4-6 years after a prior dose. In adolescents and adults, SAEs occurred at a rate of 1.3% following booster vaccination with Menactra.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 2-10 years of age (Table 2) were injection site pain and irritability.

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. Menactra participants achieved seroconversion rates of: 100%, Serogroup A (n=81/81); 99%, Serogroup C (n=153/155); 98%, Serogroup Y (n=60/61); 98%, Serogroup W-135 (n=161/164).

However, if you are pregnant, your doctor should determine whether you need this vaccine.If you are pregnant, your name may be listed on a pregnancy registry. had symptom onset 14--31 days after MCV4 vaccination. Menactra participants achieved seroconversion rates of: 100%, Serogroup A (n=156/156); 99%, Serogroup C (n=343/345); 91%, Serogroup Y (n=253/279); 97%, Serogroup W-135 (n=360/373). The antibody responses to Menactra and to Typhim Vi components were similar in both study groups.In a randomized, parallel group, US multi-center clinical trial conducted in children 4 through 6 years of age, Menactra was administered as follows: 30 days after concomitant DTaP (DAPTACELWhen Menactra was administered 30 days after DAPTACEL (and IPV) [Group A], significantly lower SBA-H GMTs to all 4 meningococcal serogroups were observed compared to Menactra (and IPV) administered 30 days prior to DAPTACEL [Group C].