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NCT00444457 · ClinicalTrials.gov registry record · Phase 3

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

A Phase 3 study of Vaccines, Pneumococcal, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

Completed
Registry status
Phase 3
Development phase
1,712
Enrollment target
20
Study locations

NCT00444457: Completed Phase 3 study of Vaccines, Pneumococcal, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

NCT00444457 is a Phase 3 study of Vaccines, Pneumococcal that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 1,712 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (122% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00444457, a Phase 3 study of Vaccines, Pneumococcal, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
1,712 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.

Primary Outcome

Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Conditions Studied

Vaccines, Pneumococcal

Interventions

  • BIOLOGICAL 13-valent Pneumococcal Conjugate Vaccine
  • BIOLOGICAL 7vPnC

Study Locations (20)

California

  • - Downey
  • - Fontana
  • - Fountain Valley
  • - Lakewood
  • - Loma Linda
  • - Moreno Valley
  • - Paramount
  • - Riverside
  • - Rolling Hills Estates

Arkansas

  • - Benton
  • - Conway
  • - Fayetteville
  • - Jonesboro
  • - Little Rock
  • - North Little Rock

Colorado

  • - Boulder
  • - Longmont

Florida

  • - Palm Beach Gardens
  • - Tampa

Connecticut

  • - Norwich

Trial Details

FieldValue
Enrollment Target 1,712 participants
Start Date 2007-05
Est. Completion 2009-06
Phase Phase 3
Wyeth is now a wholly owned subsidiary of Pfizer

167 total trials

What the finished NCT00444457 record still lists

NCT00444457 is an interventional study that assigns participants to a tested intervention. Its 1,712 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (122% higher).

The record links to 1 condition, with Vaccines, Pneumococcal appearing as the primary indexed condition, and to 2 interventions - of which 13-valent Pneumococcal Conjugate Vaccine is the first listed.

NCT00444457 names 20 study sites across 5 states, led by California, Arkansas, Colorado.

Frequently Asked Questions

What is clinical trial NCT00444457 about?

NCT00444457 is a clinical study titled "Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants". The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal ...

What is the current status of trial NCT00444457?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,712 participants. The study started on 2007-05. Estimated completion is 2009-06.

What conditions does trial NCT00444457 study?

This clinical trial studies the following conditions: Vaccines, Pneumococcal.

What interventions are being tested in trial NCT00444457?

The interventions under investigation include: 13-valent Pneumococcal Conjugate Vaccine (BIOLOGICAL), 7vPnC (BIOLOGICAL).

Who is sponsoring clinical trial NCT00444457?

This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00444457 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Vaccines, Pneumococcal

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00444457's enrollment target sits among peer trials

1,712 132nd of 2000 higher than 1,869 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00444457, the US trial registry maintained by the National Library of Medicine. NCT00444457 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.