er Menactra vaccine and Tetanus and Diphtheria Toxoid Adsorbed (Td) vaccine manufactured by Sanofi Pasteur Inc. were compared [see Drug Interactions (7), and Concomitant Vaccine Administration (14.3) 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 ≥40.0ºC 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 (7), Concomitant Vaccine Administration (14.3)] 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 post-vaccination. 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 ≥40.0ºC and seizures were not reported in either group.
6.2. Post-Marketing Reports
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.
Immune System Disorders
Hypersensitivity reactions such as anaphylactic/anaphylactoid reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension
Nervous System Disorders
Guillain-Barré syndrome, paraesthesia, vasovagal syncope, dizziness, convulsion, facial palsy, acute disseminated encephalomyelitis, transverse myelitis
Musculoskeletal and Connective Tissue Disorders
Myalgia
7.DRUG INTERACTIONS
7.1. 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 (14) and Adverse Reactions (6)].
Data are not avai
