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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 4

Conditions

Poliomyelitis
Haemophilus Influenzae Type b
Diphtheria
Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Hepatitis B
Tetanus
Acellular Pertussis

Treatments

Procedure: Blood Sampling

Study type

Interventional

Funder types

Industry

Identifiers

NCT01358825
2011-000943-26 (EudraCT Number)
115375

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

5 to 6 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 2 patient groups

Infanrix hexa Group
Experimental group
Description:
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) administered intramuscularly in study NCT00307034.
Treatment:
Procedure: Blood Sampling
Infanrix-IPV/Hib Group
Experimental group
Description:
Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (DTPa-IPV/Hib) administered intramuscularly in study NCT00307034.
Treatment:
Procedure: Blood Sampling

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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