Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Vaccines

Treatments: Biological: 13vPnC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824655

6096A1-3012

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Ages: 140 to 392 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

Group 1

Experimental group

Treatment:

Biological: 13vPnC

Biological: 13vPnC

Group 2

Experimental group

Treatment:

Biological: 13vPnC

Biological: 13vPnC