| Author | Safadi, Marco Aurelio Palazzi | |
| Author | Torres, Federico Martinon | |
| Author | Weckx, Lily Yin | |
| Author | Moreira Junior, Edson Duarte | |
| Author | Lima, Eduardo Jorge da Fonseca | |
| Author | Mensi, Ilhem | |
| Author | Calabresi, Marco | |
| Author | Toneatto, Daniela | |
| Access date | 2018-04-02T18:42:50Z | |
| Available date | 2018-04-02T18:42:50Z | |
| Document date | 2017 | |
| Citation | SAFADI, M. A. P. et al. 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. Vaccine, v. 35, p. 2052–2059, 2017. | pt_BR |
| ISSN | 0264-410X | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/25564 | |
| Sponsorship | Novartis Vaccines and Diagnostics, Inc., now GlaxoSmithKline Biologicals SA. | pt_BR |
| Language | eng | pt_BR |
| Publisher | Elsevier | pt_BR |
| Rights | open access | pt_BR |
| Subject in Portuguese | 4CMenB | pt_BR |
| Subject in Portuguese | MenC-CRM | pt_BR |
| Subject in Portuguese | Bebês | pt_BR |
| Subject in Portuguese | Imunogenicidade | pt_BR |
| Subject in Portuguese | Segurança | pt_BR |
| Title | 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 | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1016/j.vaccine.2017.03.002 | |
| 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. | pt_BR |
| Affilliation | Santa Casa de São Paulo. School of Medical Sciences and CDEC. São Paulo, SP, Brazil | pt_BR |
| Affilliation | Hospital Clinico Universitario de Santiago de Compostela. Santiago de Compostela, Spain | pt_BR |
| Affilliation | Universidade Federal de São Paulo. São Paulo, SP, Brasil | pt_BR |
| Affilliation | Associação Obras Sociais Irma Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil | pt_BR |
| Affilliation | Instituto de Medicina Integral Professor Fernando Figueira. Boa Vista Recife, PE, Brasil | pt_BR |
| Affilliation | GSK. Amsterdam, The Netherlands | pt_BR |
| Affilliation | GSK. Siena, Italy | pt_BR |
| Affilliation | GSK. Siena, Italy | pt_BR |
| Subject | 4CMenB | pt_BR |
| Subject | MenC-CRM | pt_BR |
| Subject | Infants | pt_BR |
| Subject | Immunogenicity | pt_BR |
| Subject | Safety | pt_BR |
