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Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

NCT01453998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2020-07-17

Study results available
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Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.

Conditions

  • Acellular Pertussis
  • Hepatitis B
  • Haemophilus Influenzae Type b
  • Tetanus
  • Diphtheria
  • Poliomyelitis

Interventions

BIOLOGICAL

Infanrix hexa

Single dose, licensed formulation, intramuscular into right thigh

BIOLOGICAL

Prevenar 13

Single co-administered dose, intramuscular into left thigh

BIOLOGICAL

GSK217744

Single dose, investigational formulation A or B, intramuscular into right thigh

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-14
Primary Completion
2012-11-12
Completion
2012-11-12

Countries

  • Dominican Republic
  • Finland

Study Locations

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Entities

Diseases
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 NCT01453998 on ClinicalTrials.gov