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Vaccine. 2019 Aug 14;37(35):4858-4863. doi: 10.1016/j.vaccine.2019.07.021. Epub 2019 Jul 18.

Immunogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with the meningococcal serogroup B (4CMenB) vaccine in infants: A post-hoc analysis in a phase 3b, randomised, 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; Genetics, Vaccines and Pediatrics Research Group (GENVIP), Instituto de Investigación Sanitaria de Santiago, University of Santiago de Compostela, Spain. Electronic address: federico.martinon.torres@sergas.es.
3
Federal University of Sao Paulo, Brazil. Electronic address: lily.crie@huhsp.org.br.
4
CPEC - Associação Obras Sociais Irma Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Salvador, Brazil. Electronic address: edson@bahia.fiocruz.br.
5
CPEC - Instituto de Medicina Integral Professor Fernando Figueira, Boa Vista Recife, PE, Brazil. Electronic address: eduardojorge@imip.org.br.
6
Plus100 B.V. c/o Biostatistics, GSK, Amsterdam, the Netherlands. Electronic address: arnold.x.willemsen@gsk.com.
7
GSK, Siena, Italy. Electronic address: daniela.x.toneatto@gsk.com.
8
GSK, Wavre, Belgium. Electronic address: ahsan.m.habib@gsk.com.
9
GSK, Wavre, Belgium. Electronic address: dorota.d.borys@gsk.com.

Abstract

BACKGROUND:

No data are currently available on immunogenicity of higher-valent pneumococcal conjugate vaccines when co-administered with a 4-component meningococcal serogroup B vaccine (4CMenB).

METHODS:

Post-hoc analysis of pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) immunogenicity when co-administered with 4CMenB (2 + 1 schedule) and/or a CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM) in a trial assessing 4CMenB reduced schedules and co-administration with MenC-CRM (NCT01339923). Infants were randomized to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM (Group 2) at 3, 5, and 12 months (M) of age. Both groups received PHiD-CV (3 + 1 schedule) as part of the Brazilian national immunisation programme at 3 M, 5 M, 7 M, and 12 M of age. Antibody responses were assessed pre-vaccination, 1 M post-dose 2, pre-booster, and 1 M post-booster.

RESULTS:

Anti-pneumococcal antibody responses were in similar ranges in the two study groups.

CONCLUSIONS:

4CMenB co-administration did not seem to impact antibody responses to PHiD-CV in infants.

KEYWORDS:

Co-administration; Immunogenicity; Infants; Meningococcal conjugate vaccine; Pneumococcal conjugate vaccine

PMID:
31327652
DOI:
10.1016/j.vaccine.2019.07.021
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