Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal Conjugate Vaccine

Treatments: Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC); Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00676091

6096A1-012

Details and patient eligibility

About

The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.

Enrollment: 354 patients

Sex: All

Ages: 28 to 54 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 1 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 vaccine 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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354 participants in 2 patient groups

13vPnC

Experimental group

Description:

13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Treatment:

Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

7vPnC

Active Comparator group

Description:

7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Treatment:

Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)