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

NCT00743652 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 373

Last updated 2012-03-15

Study results available
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Summary

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

Conditions

  • Pneumococcal Disease
  • 13-valent Pneumococcal Vaccine

Interventions

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00743652 on ClinicalTrials.gov