Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

Pfizer

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal

Treatments: Biological: 7vPnc pneumococcal conjugate vaccine; Biological: 13 valent pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00373958

6096A1-004

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.

Enrollment: 666 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 2-month-old infants.
• Available for the entire study period.

Exclusion criteria

• Previous vaccination with any vaccine before the start of the study.
• Known contraindication to vaccination.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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666 participants in 2 patient groups

13vPnC vaccine

Experimental group

Treatment:

Biological: 13 valent pneumococcal conjugate vaccine

7vPnC vaccine

Active Comparator group

Treatment:

Biological: 7vPnc pneumococcal conjugate vaccine