Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00508742

6096A1-3006

B1851007

Details and patient eligibility

About

This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.

Enrollment: 1,866 patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants aged 2 months (42-98 days) at time of enrolment.
• Available for the entire study period and whose parent/legal guardian can be reached by telephone.

Exclusion criteria

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with a pneumococcal conjugate vaccine.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,866 participants in 2 patient groups

1

Experimental group

Description:

13 valent pneumococcal conjugate vaccine

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

2

Active Comparator group

Description:

7 valent pneumococcal conjugate vaccine

Treatment:

Biological: 7 valent pneumococcal conjugate vaccine