Text Size

Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01358825
First received: May 20, 2011
Last updated: March 14, 2013
Last verified: September 2011
History of Changes
  Purpose

The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.


Condition Intervention Phase
Poliomyelitis
Diphtheria
Hepatitis B
Haemophilus Influenzae Type b Disease
Pertussis
Tetanus
 Procedure: Blood Sampling
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to the components of the study vaccines in terms of antibody concentrations/titres. [ Time Frame: At 5 years of age. ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects who were previously primed with 3 doses of Infanrix hexa™ in study NCT00307034.
 Procedure: Blood Sampling
A blood sample will be taken at 5 years of age, after vaccination in the primary study.
Experimental: Group B
Subjects who were previously primed with 3 doses of Infanrix-IPV/Hib™ in study NCT00307034.
 Procedure: Blood Sampling
A blood sample will be taken at 5 years of age, after vaccination in the primary study.

  Eligibility

Ages Eligible for Study:   5 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who had received 3 doses of Infanrix hexa™ or Infanrix-IPV/Hib™ in study NCT00307034.
  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol.
  • A male or female subject aged 5 years at the time of study entry.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Child in care.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product within 30 days prior to blood sampling.
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib vaccination or disease since the study NCT00307034, with the exception of hepatitis B vaccination in the DTPa-IPV/Hib group.
  • Administration of immunoglobulins and/or any blood products within the 3 months prior to blood sampling.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358825

Locations
Norway
GSK Investigational Site
Morvik, Norway, 5124
GSK Investigational Site
Oslo, Norway, 0130
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01358825     History of Changes
Other Study ID Numbers: 115375
Study First Received: May 20, 2011
Last Updated: March 14, 2013
Health Authority: Norway: The Royal Norwegian Ministry of Health and Care Services
Norway: Statens Legemiddelverk
Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
Infanrix-IPV/Hib
Long-term follow up
Persistence
Infanrix hexa

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections

ClinicalTrials.gov processed this record on May 16, 2013