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Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

NCT00814710 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-01-03

Study results available
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Summary

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.

Conditions

  • Infections, Streptococcal
  • Streptococcus Pneumoniae

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine GSK1024850A

Intramuscular injection, 3 doses

BIOLOGICAL

Tritanrix-HepB/Hib

Intramuscular injection, 3 doses

BIOLOGICAL

Hiberix

Intramuscular injection, 3 doses

BIOLOGICAL

Tritanrix-HepB

Intramuscular injection, 3 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-07
Primary Completion
2009-11-13
Completion
2009-11-13

Countries

  • India

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 NCT00814710 on ClinicalTrials.gov