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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

NCT00824655 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2011-08-10

Study results available
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Summary

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Conditions

  • Pneumococcal Vaccines

Interventions

BIOLOGICAL

13vPnC

13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.

BIOLOGICAL

13vPnC

13vPnC will be administered by intramuscular injection at approximately 12 months of age.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
140 Days
Max Age
392 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Sweden

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 NCT00824655 on ClinicalTrials.gov