MedTrace Logo

Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

NCT00513409 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2018-12-19

Study results available
· View outcomes & findings →

Summary

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.

This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Synflorix

Intramuscular injection, 1 or 2 doses

BIOLOGICAL

Infanrix Hexa

1 Intramuscular injection

BIOLOGICAL

Havrix

1 Intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
21 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-22
Primary Completion
2008-02-20
Completion
2008-08-28

Countries

  • Chile

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 NCT00513409 on ClinicalTrials.gov