Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaccines, Pneumococcal Conjugate Vaccine

Treatments: Biological: 7-valent pneumococcal conjugate vaccine; Biological: 13-valent Pneumococcal Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475033

6096A1-3008

Details and patient eligibility

About

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations in Canada. Immune responses induced by the infant series (NeisVac-C® and Pentacel®)and toddler dose(NeisVac-C®)of routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine will be studied for noninferiority to the immune responses when administered with 7-valent pneumococcal conjugate vaccine. Safety profile and immunogenicity of 13-valent pneumococcal conjugate vaccine will also be evaluated.

Enrollment: 603 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 2-month old infants (42 to 98 days)
• Available for the duration of the study and reachable by telephone

Exclusion criteria

• Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccine
• Previous anaphylactic reaction to any vaccine or vaccine-related component.
• Bleeding disorder, immune deficiency or suppression, or significant chronic or congenital disease
• Receipt of blood products or gamma globulin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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603 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

2

Active Comparator group

Treatment:

Biological: 7-valent pneumococcal conjugate vaccine