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Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: A randomized controlled trial

JAMA, ISSN: 1538-3598, Vol: 307, Issue: 6, Page: 573-582
2012
  • 311
    Citations
  • 0
    Usage
  • 146
    Captures
  • 3
    Mentions
  • 0
    Social Media
Metric Options:   Counts1 Year3 Year

Metrics Details

  • Citations
    311
    • Citation Indexes
      260
    • Policy Citations
      49
      • Policy Citation
        49
    • Clinical Citations
      2
      • PubMed Guidelines
        2
  • Captures
    146
  • Mentions
    3
    • News Mentions
      2
      • News
        2
    • References
      1
      • Wikipedia
        1

Most Recent News

Bexsero™and Routine Infant Vaccines: Effect of Coadministration on the Safety of Immunization

STUDY INFORMATION OFFICIAL TITLE: Interaction Between Meningococcal Serogroup B Vaccine (Bexsero™) and Routine Infant Vaccines on the Risk of Occurrence and Recurrence of Adverse Events

Article Description

Context: In the absence of an effective vaccine, serogroup B Neisseria meningitidis (MenB) remains a major cause of invasive disease in early childhood in developed countries. Objective: To determine the immunogenicity and reactogenicity of a multicomponent MenB vaccine (4CMenB) and routine infant vaccines when given either concomitantly or separately. Design, Setting, and Participants: Phase 2b, multicenter, open-label, parallel-group, randomized controlled study of 1885 infants enrolled at age 2 months from August 2008 to July 2010 in Europe. Intervention: Participants were randomized 2:2:1:1 to receive (1) 4CMenB at 2, 4, and 6 months with routine vaccines (7-valent pneumococcal and combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, Haemophilus influenzae type b vaccines); (2) 4CMenB at 2, 4, and 6 months and routine vaccines at 3, 5, and 7 months; (3) 4CMenB with routine vaccines at 2, 3, and 4 months; or (4) routine vaccines alone at 2, 3, and 4 months. Main Outcome Measures: Percentage of participants with human complement serum bactericidal activity (hSBA) titer of 1:5 or greater against 3 MenB strains specific for vaccine antigens (NZ98/254, 44/76-SL, and 5/99). Results: After three 4CMenB vaccinations, 99% or more of infants developed hSBA titers of 1:5 or greater against strains 44/76-SL and 5/99. For NZ98/254, this proportion was 79% (95% CI, 75.2%-82.4%) for vaccination at 2, 4, and 6 months with routine vaccines, 86.1% (95% CI, 82.9%-89.0%) for vaccination at 2, 4, and 6 months without routine vaccines, and 81.7% (95% CI, 76.6%-86.2%) for vaccination at 2, 3, and 4 months with routine vaccines. Responses to routine vaccines given with 4CMenB were noninferior to routine vaccines alone for all antigens, except for the responses to pertactin and serotype 6B pneumococcal polysaccharide. Fever was seen following 26% (158/602) to 41% (247/607) of 4CMenB doses when administered alone, compared with 23% (69/304) to 36% (109/306) after routine vaccines given alone and 51% (306/605) to 61% (380/624) after 4CMenB and routine vaccines administered together. Conclusion: A 4CMenB vaccine is immunogenic against reference strains when administered with routine vaccines at 2, 4, and 6 or at 2, 3, and 4 months of age, producing minimal interference with the response to routine infant vaccinations. Trial Registration: clinicaltrials.gov Identifier: NCT00721396. ©2012 American Medical Association. All rights reserved.

Bibliographic Details

Gossger, Nicoletta; Snape, Matthew D; Yu, Ly-Mee; Finn, Adam; Bona, Gianni; Esposito, Susanna; Principi, Nicola; Diez-Domingo, Javier; Sokal, Etienne; Becker, Birgitta; Kieninger, Dorothee; Prymula, Roman; Dull, Peter; Ypma, Ellen; Toneatto, Daniela; Kimura, Alan; Pollard, Andrew J; European MenB Vaccine Study Group

American Medical Association (AMA)

Medicine

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