Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A

NCT01175083 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-06-06

Study results available
· View outcomes & findings →

Summary

The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.

Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

GSK1024850A (Synflorix)

2, 3 or 4 intramuscular injection

BIOLOGICAL

Tritanrix-HepB/Hib

Intramuscular injection, 4 doses

BIOLOGICAL

Polio Sabin

4 oral doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-01
Primary Completion
2013-01-17
Completion
2013-05-23

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

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 NCT01175083 on ClinicalTrials.gov