Evaluating the Safety and Immune Response to Two Pneumococcal Vaccines in HIV-Infected Pregnant Women

NCT01443117 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-11-01

No results posted yet for this study

Summary

HIV-infected people and pregnant women are at risk of developing severe pneumococcal disease. The purpose of this study is to compare the safety and immune response to two pneumococcal vaccines in HIV-infected pregnant women.

Conditions

  • Pneumococcal Infections
  • HIV Infections

Interventions

BIOLOGICAL

PPV-23 Vaccine

Administered as a 0.5 mL IM dose

BIOLOGICAL

PCV-13 Vaccine

Administered as a 0.5 mL IM dose

BIOLOGICAL

Placebo Vaccine

Administered as a 0.5 mL IM dose

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Adriana Weinberg, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2014-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443117 on ClinicalTrials.gov