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Serogroup B meningococcal vaccine well tolerated when administered with other vaccines
Gossger N. JAMA. 2012;307:573-582.
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A multicomponent serogroup B meningococcal vaccine was well tolerated and effective when administered with routine infant vaccinations, according to results of a recent study.
Nicolette Gossger, MD, and colleagues from the Oxford Vaccine Group of the University of Oxford in England examined data from 1,810 healthy, full-term infants to determine the immunogenicity and reactogenicity of serogroup B meningococcal vaccine (4CMenB, Novartis) when administered at the same time or separately from routine vaccinations.
Infants were randomly assigned to four vaccination groups in a 2:2:1:1 ratio: 4CMenB given at ages 2, 4 and 6 months concomitantly with routine vaccination; 4CMenB given at 2, 4 and 6 months with routine vaccinations administered at 3, 5 and 7 months intercalated; 4CMenB given at 2, 4 and 6 months concomitantly with an accelerated routine vaccination schedule, and a control group of patients who received only routine vaccines at 2, 3 and 4 months. For this study, routine vaccines were referred to as combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, and Haemophilus influenzae type b vaccine (DTaP-HBV-IPV/Hib; Infanrix Hexa, GlaxoSmithKline) and 7-valent pneumococcal glycoconjugate vaccine (Prevnar, Wyeth).
The 4CMenB vaccine had higher immunogenicity when given intercalated than concomitantly, but the researchers said the clinical significance of this is uncertain. Responses to pertactin and pneumococcal serotype 6B were slightly reduced in the groups that received concomitant 4CMenB, but this was “unlikely to be of clinical significance.”
“4CMenB was immunogenic, generally well tolerated, and showed minimal interference with routine vaccinations in the first year of life,” the researchers concluded. “The flexibility in schedule allows it to be incorporated into a range of country-specific immunization schedules and for primary immunization to be completed in early infancy.”
In an accompanying editorial, CDC researchers said if this vaccine were licensed in the United States and Europe, it would be the first time that a vaccine would be available to prevent all five meningococcal serotypes. However, they noted, this vaccine has limitations, in that some data suggest it may not be as effective against the current serogroup C vaccine in the United Kingdom.
Disclosure: The study was funded by Novartis. Dr. Gossger reports no relevant financial disclosures.
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