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Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam

NCT01153841 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-01-02

Study results available
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Summary

The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.

Conditions

  • Infections, Streptococcal
  • Streptococcus Pneumoniae Vaccines

Interventions

BIOLOGICAL

Synflorix™( GSK1024850A)

Intramuscular, 3 doses

BIOLOGICAL

Infanrix hexa™

Intramuscular, 3 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-17
Primary Completion
2011-07-26
Completion
2011-07-26

Countries

  • Vietnam

Study Locations

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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 NCT01153841 on ClinicalTrials.gov