CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 331 enrolled
Drug / intervention
13-valent pneumococcal conjugate vaccine +1 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/NCT00963235
NCT00963235Phase 3Completed
CompareCT.gov

A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 3 Doses of 13vPnC Vaccine in HIV-Infected Subjects 18 Years of Age or Older Who Have Been Previously Immunized With 23vPS Vaccine

Pfizer·interventional·Posted Aug 21, 2009·Updated Jun 10, 2013

In Brief

A Phase 3 clinical trial evaluating 13-valent pneumococcal conjugate vaccine and Blood draw for HIV Infections and Pneumococcal Infections. Completed, enrolled 331 participants across 15 sites.

Detailed Summary

The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Pneumococcal Infections
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 21, 2009
Enrollment StartNov 1, 2009
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.9 years ago

Interventions

13-valent pneumococcal conjugate vaccinebiological

Three doses of 13vPnC given 6 months apart.

Blood drawprocedure

Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.