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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar

NCT00824655•Pfizer

View on ClinicalTrials.gov

Summary

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy children previously immunized with 1 or 2 doses of Prevenar.
•Group 1: Male or female subjects between the age of \>=140 and \<=196 days of age at time of enrollment.
•Group 2: Male or female subjects between the age of \>=336 and \<=392 days of age at time of enrollment
•Available for entire study period.

Exclusion Criteria

•Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
•Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.

Locations (7)

Pfizer Investigational Site

Eskilstuna, Sweden

Pfizer Investigational Site

Gothenburg, Sweden

Pfizer Investigational Site

Malmo, Sweden

Pfizer Investigational Site

Örebro, Sweden

Pfizer Investigational Site

Östersund, Sweden

Pfizer Investigational Site

Uddevalla, Sweden

Pfizer Investigational Site

Umeå, Sweden

Key Dates

Start Date

March 1, 2009

Primary Completion Date

June 1, 2010

Completion Date

June 1, 2010

Last Updated

August 10, 2011

Enrollment

234

ACTUAL participants

Conditions

Pneumococcal Vaccines

Interventions

13vPnC

BIOLOGICAL

13vPnC

BIOLOGICAL

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Pneumococcal VaccinesImmunization Coverage

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COMPLETEDPHASE3

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NCT03893448

Pneumococcal InfectionsPneumococcal Vaccines

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 10, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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