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https://www.arca.fiocruz.br/handle/icict/25564
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
Affilliation
Santa Casa de São Paulo. School of Medical Sciences and CDEC. São Paulo, SP, Brazil
Hospital Clinico Universitario de Santiago de Compostela. Santiago de Compostela, Spain
Universidade Federal de São Paulo. São Paulo, SP, Brasil
Associação Obras Sociais Irma Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
Instituto de Medicina Integral Professor Fernando Figueira. Boa Vista Recife, PE, Brasil
GSK. Amsterdam, The Netherlands
GSK. Siena, Italy
GSK. Siena, Italy
Hospital Clinico Universitario de Santiago de Compostela. Santiago de Compostela, Spain
Universidade Federal de São Paulo. São Paulo, SP, Brasil
Associação Obras Sociais Irma Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
Instituto de Medicina Integral Professor Fernando Figueira. Boa Vista Recife, PE, Brasil
GSK. Amsterdam, The Netherlands
GSK. Siena, Italy
GSK. Siena, Italy
Abstract
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 MenCCRM
alone (Group 2) at 3 and 5 months (M3, M5) and a booster at 12 months 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 7 days 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.
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