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

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ClinicalTrials.gov Identifier: NCT01358825

Recruitment Status : Completed

First Posted : May 24, 2011

Results First Posted : December 29, 2016

Last Update Posted : January 19, 2021

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Tetanus Poliomyelitis Haemophilus Influenzae Type b Acellular Pertussis Diphtheria Hepatitis B Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines	Procedure: Blood Sampling	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	58 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Antibody Persistence in Children Previously Vaccinated With Three Doses of Infanrix Hexa™ or Infanrix-IPV/Hib™
Actual Study Start Date :	May 30, 2011
Actual Primary Completion Date :	July 15, 2011
Actual Study Completion Date :	July 15, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Haemophilus Infections Tetanus, Diphtheria, and Pertussis Vaccines

Drug Information available for: Boostrix Diphtheria-Tetanus-acellular Pertussis Vaccines

Genetic and Rare Diseases Information Center resources: Whooping Cough Tetanus Poliomyelitis Diphtheria Haemophilus Influenzae Myelitis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Infanrix hexa Group 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.	Procedure: Blood Sampling A blood sample will be taken at 5 years of age, after vaccination in the primary study.
Experimental: Infanrix-IPV/Hib Group 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.	Procedure: Blood Sampling A blood sample will be taken at 5 years of age, after vaccination in the primary study.

Outcome Measures

Primary Outcome Measures :

Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). [ Time Frame: At Day 0 ]
A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)
Concentrations of Antibodies Against Anti-D and Anti-T [ Time Frame: At Day 0 ]
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL). [ Time Frame: At Day 0 ]
Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.
Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN. [ Time Frame: At Day 0 ]
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs). [ Time Frame: At Day 0 ]
Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Concentrations of Antibodies Against Anti-HBs. [ Time Frame: At Day 0 ]
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP). [ Time Frame: At Day 0 ]
A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)
Concentrations of Antibodies Against Anti-PRP. [ Time Frame: At Day 0 ]
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).
Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (up to Day 46) ]
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL [ Time Frame: At Day 0 ]
Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 6 Years (Child)
Sexes Eligible for Study:	All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358825

Locations

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Norway
GSK Investigational Site
Morvik, Norway, 5124
GSK Investigational Site
Oslo, Norway, 0130
Sweden
GSK Investigational Site
Umeå, Sweden, SE-901 85
GSK Investigational Site
Örebro, Sweden, SE-702 11

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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