Status:

COMPLETED

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Lead Sponsor:

Pfizer

Conditions:

Pneumococcal Vaccines

Eligibility:

All Genders

140-392 years

Phase:

PHASE3

Brief 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 im...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

March 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

234 Patients enrolled

Trial Details

Trial ID

NCT00824655

Start Date

March 1 2009

End Date

June 1 2010

Last Update

August 10 2011

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Pfizer Investigational Site

Eskilstuna, Sweden, SE-63188

2

Pfizer Investigational Site

Gothenburg, Sweden, SE-40014

3

Pfizer Investigational Site

Malmo, Sweden, SE-20502

4

Pfizer Investigational Site

Örebro, Sweden, SE-70185