Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease; 13-valent Pneumococcal Vaccine

Treatments: Biological: 13-valent Pneumococcal Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00743652

B1851009

6096A1-3010

Details and patient eligibility

About

This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.

Enrollment: 373 patients

Sex: All

Ages: 42 days to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
• Infants who have received Prevnar are eligible to participate, but this is not required.
• Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Exclusion criteria

• Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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373 participants in 5 patient groups

Group1

Experimental group

Description:

Subjects 6 weeks to \<10 months of age with 0 prior dose of Prevnar.

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Group 2

Experimental group

Description:

Subjects \<12 months of age with 1 prior dose of Prevnar.

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Group 3

Experimental group

Description:

Subjects \<12 months of age with 2 prior doses of Prevnar.

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Group 4

Experimental group

Description:

Subjects ≥12 months to \<2 years of age.

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Group 5

Experimental group

Description:

Subjects ≥2 years to \<5 years of age

Treatment:

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine