CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 347 enrolled
Drug / intervention
PPV-23 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02717494
NCT02717494Phase 2Completed
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Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women

Westat·interventional·Posted Mar 23, 2016·Updated Jan 18, 2020

In Brief

A Phase 2 clinical trial evaluating PPV-23, PCV-10, and 1 other intervention for PNC Vaccine and HIV-infected Pregnant Women. Completed, enrolled 347 participants across 8 sites.

Detailed Summary

The purpose of this study was to determine the safety, reactogenicity, immunogenicity, transplacental antibody transfer and interference with infant responses to childhood vaccination of maternal vaccination with pneumococcal conjugate 10-valent vaccine (PCV-10) or pneumococcal polysaccharide 23-valent vaccine (PPV-23) by comparison with placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPNC Vaccine, HIV-infected Pregnant Women
CountriesBrazil
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 23, 2016
Enrollment StartMar 1, 2016
Primary CompletionNov 1, 2018
Study CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.3 years ago

Interventions

PPV-23biological

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

PCV-10biological

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

NaClother

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