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Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

NCT01204658 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2019-05-29

Study results available
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Summary

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal vaccine GSK 2189242A (LD formulation 1)

Intramuscular injection

BIOLOGICAL

Pneumococcal vaccine GSK 2189242A (HD formulation 2)

Intramuscular injection

BIOLOGICAL

Synflorix

Intramuscular injection

BIOLOGICAL

Prevenar 13

Intramuscular injection

BIOLOGICAL

Infanrix Hexa (DTPa-HBV-IPV/Hib)

Intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-27
Primary Completion
2011-11-03
Completion
2012-10-01

Countries

  • Czechia
  • Germany
  • Poland
  • Sweden

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 NCT01204658 on ClinicalTrials.gov