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

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)

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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