CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 249 enrolled
Drug / intervention
13-Valent Pneumococcal Conjugate Vaccine (13vPnC) +1 morebiological
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Aged 6 weeks to 14 weeks (42–98 days) at enrollment
  • ✓In good health as determined by medical history, physical examination, and investigator judgment
  • ✓Born at ≥36 weeks gestational age
  • ✓Available for entire study period with parent/legal guardian reachable by telephone
Key exclusion· 10
  • ✕Prior pneumococcal vaccine (licensed or investigational)
  • ✕Prior Hib conjugate, DTaP, or IPV vaccines
  • ✕Contraindication to HepB, Hib conjugate, DTaP, or IPV immunization
  • ✕Significant neurological disorder or seizure history (including febrile seizure), cerebral palsy, encephalopathy, hydrocephalus

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

Search/NCT00205803
NCT00205803Phase 2Completed
CompareCT.gov

A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Sep 20, 2005·Updated Aug 15, 2012

In Brief

A Phase 2 clinical trial evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) and 7-Valent Pneumococcal Conjugate Vaccine (7vPnC) for Healthy Subjects and Pneumococcal Infections. Completed, enrolled 249 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartSep 1, 2004
Study CompletionMay 1, 2007
TodayJul 2, 2026
Posted 20.8 years ago

Interventions

13-Valent Pneumococcal Conjugate Vaccine (13vPnC)biological

7-Valent Pneumococcal Conjugate Vaccine (7vPnC)biological