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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 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. The trial reports 20 study locations across 5 states.

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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.

Conditions Studied

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

What the Registry Record Tells You About NCT00444457

The ClinicalTrials.gov registry entry for NCT00444457 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,712 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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