Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal

Treatments: Biological: 13-valent Pneumococcal Conjugate Vaccine; Biological: 7vPnC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444457

6096A1-3005

Details and patient eligibility

About

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.

Enrollment: 1,712 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 2 month old infants
• Available for the duration of the study and reachable by telephone
• Able to complete two blood drawing procedures during the study

Exclusion criteria

• Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
• Bleeding disorder, immune deficiency or significant chronic or congenital disease
• Previous receipt of blood products or immune globulin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,712 participants in 4 patient groups

1

Experimental group

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

2

Experimental group

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

3

Experimental group

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

4

Active Comparator group

Treatment:

Biological: 7vPnC