Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women

PHASE2CompletedINTERVENTIONAL
Enrollment

347

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

November 30, 2018

Study Completion Date

May 31, 2019

Conditions
PNC VaccineHIV-infected Pregnant Women
Interventions
BIOLOGICAL

PPV-23

PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.

BIOLOGICAL

PCV-10

PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.

OTHER

NaCl

NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.

Trial Locations (8)

30130-100

FUNDEP (Belo Horizonte), Belo Horizonte

26030-380

Hospital Geral de Nova Iguaçu Avenida Henrique Duque Estrada Mayer, Nova Iguaçu

21 940 590

Instituto de Puericultura e Pediatria Martagao Gesteria, Rio de Janeiro

20221-161

Hospital dos Servidores (Rio de Janeiro), Saúde

95070-560

Universidade de Caxias do Sul. Brasil, Caxias do Sul

90020-090

Hospital Santa Casa Porto Alegre Brazil, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

14049-900

Ribeirão Preto Medical School, University of São Paulo, Brazil, Ribeirão Preto

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Westat

OTHER