MedTrace Logo

Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

NCT00488826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2010-01-20

Study results available
· View outcomes & findings →

Summary

This study is a combination of a Phase I and Phase III study design. The Phase I portion is an open-label, controlled study to evaluate the safety of 7vPnC in healthy Chinese infants. The Phase III portion is an open-label, controlled, randomized study to evaluate the safety and immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)in healthy Chinese infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and /or Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) at about 3, 4, and 5 months of age; and a Booster Dose which includes the 4th dose of 7vPnC at 12-15 months of age.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

7-valent pneumococcal conjugate vaccine

BIOLOGICAL

Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
90 Days
Max Age
120 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Completion
2007-05-31

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 NCT00488826 on ClinicalTrials.gov