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Vaccine. 2017 Apr 11;35(16):2052-2059. doi: 10.1016/j.vaccine.2017.03.002. Epub 2017 Mar 18.

Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial.

Author information

1
Santa Casa de São Paulo School of Medical Sciences and CDEC, São Paulo, Brazil. Electronic address: masafadi@uol.com.br.
2
Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
3
CRIE UNIFESP, Universidade Federal de São Paulo, São Paulo, Brazil.
4
CPEC - Associação Obras Sociais Irma Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil.
5
Instituto de Medicina Integral Professor Fernando Figueira, Boa Vista Recife, PE, Brazil.
6
GSK, Amsterdam, The Netherlands.
7
GSK, Siena, Italy.

Abstract

BACKGROUND:

After implementation of routine infant MenC vaccination, MenB remains a serious cause of meningococcal disease, yet to be targeted by vaccination programs in several countries. This study (NCT01339923) investigated the immunogenicity and safety of MenC CRM-conjugated vaccine (MenC-CRM) concomitantly administered with MenB vaccine (4CMenB).

METHODS:

Infants (N=251) were randomised 1:1 to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM alone (Group 2) at 3 and 5months (M3, M5) and a booster at 12months of age (M12), and pneumococcal vaccine at M3, M5, M7, M12. Antibody responses to meningococcal vaccines were measured at M3, M6, M12, and M13. Non-inferiority of MenC-CRM response in Group 1 vs Group 2 was demonstrated at M6 and M13, if the lower limit of the 95% confidence interval (LL95%CI) of the difference in percentage of infants with hSBA titres ≥1:8 was >-10%. Sufficiency of MenB response was achieved if LL95%CI of the percentage of infants with hSBA titres ≥1:4 against fHbp, NadA and PorA strains was ≥70% at M6 or ≥75% at M13. Adverse events (AEs) were collected for 7days post-vaccination, and serious AEs (SAEs) and medically attended AEs throughout the study.

RESULTS:

Non-inferiority of MenC response in Group 1 vs Group 2 (LL95%CI -6.4% [M6]; -5.2% [M13]) and sufficiency of MenB response in Group 1 (LL95%CI 92%, 90%, 89% [M6]; 97%, 92%, 93% [M13] against fHbp, NadA, PorA, respectively) were demonstrated. Higher rates of mild to moderate solicited AEs were reported in Group 1. Unsolicited AEs and SAEs incidences were similar across groups.

CONCLUSIONS:

Concomitant administration of MenC-CRM and 4CMenB in infants was immunogenic, resulting in non-inferior responses against MenC compared to MenC-CRM alone and demonstration of sufficient immune response to MenB, after primary and booster vaccination. Reactogenicity was higher for concomitant vaccines administration, but no safety concerns were identified.

KEYWORDS:

4CMenB; Immunogenicity; Infants; MenC-CRM; Safety

PMID:
28318767
DOI:
10.1016/j.vaccine.2017.03.002
[Indexed for MEDLINE]
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