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Safety of and Immune Response to a Pneumococcal Vaccine (PncCV) in HIV Infected and Uninfected Children

NCT00099658 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 579

Last updated 2011-02-15

No results posted yet for this study

Summary

Infection by Streptococcal pneumoniae is a common invasive bacterial infection in HIV infected children. The purpose of this study is to determine the safety of and immune response to a pneumococcal polysaccharide-protein conjugate vaccine (PncCV) in HIV infected and uninfected children. The study will also determine the safety of and immune response to Haemophilus influenzae vaccine (HibCV) in these children. Recruitment for this study will occur at two hospitals in South Africa, and all HIV infected infants participating in this study must also be coenrolled in the CIPRA SA-Project 2 study.

Conditions

  • HIV Infections
  • Pneumococcal Infections

Interventions

BIOLOGICAL

Pneumococcal polysaccharide-protein conjugate vaccine

Injection administered three times before the age of 24 weeks

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • CIPRA SA

    lead NETWORK

Principal Investigators

  • Shabir Madhi, MD, MBBCH, Mmed, FCPaeds, PhD · Chris Hani Baragwanath Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2013-12-31
Completion
2014-06-30

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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 NCT00099658 on ClinicalTrials.gov