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Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.

NCT00743652•Pfizer

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

0 - 5 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (21)

Pfizer Investigational Site

Akiak, Alaska, United States

Pfizer Investigational Site

Bethel, Alaska, United States

Pfizer Investigational Site

Chefornak, Alaska, United States

Pfizer Investigational Site

Chevak, Alaska, United States

Pfizer Investigational Site

Eek, Alaska, United States

Pfizer Investigational Site

Emmonak, Alaska, United States

Pfizer Investigational Site

Hooper Bay, Alaska, United States

Pfizer Investigational Site

Kalskag, Alaska, United States

Pfizer Investigational Site

Kasigluk, Alaska, United States

Pfizer Investigational Site

Kongiganak, Alaska, United States

Key Dates

Start Date

January 1, 2009

Primary Completion Date

September 1, 2010

Completion Date

September 1, 2010

Last Updated

March 15, 2012

Enrollment

373

ACTUAL participants

Conditions

Pneumococcal Disease13-valent Pneumococcal Vaccine

Interventions