MedTrace Logo

Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

NCT00368966 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 619

Last updated 2012-08-16

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations in Spain.

Conditions

  • Vaccines, Pneumococcal

Interventions

BIOLOGICAL

13-valent Pneumococcal Conjugate Vaccine

BIOLOGICAL

7-valent Pneumococcal Conjugate Vaccine

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

  • Trial Manager · For Spain, [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
98 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Spain

Study Locations

More Related Trials

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 NCT00368966 on ClinicalTrials.gov