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

Phase 4

Completed

• Conditions: Diphtheria; Acellular Pertussis; Poliomyelitis; Haemophilus Influenzae Type b; Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines; Hepatitis B; Tetanus
• Interventions: Procedure: Blood Sampling

• Registration Number: NCT01358825
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-24
• Study Start: 2011-05-30
• Primary Completion: 2011-07-15
• Study Completion: 2011-07-15
• Results First Submitted: 2016-11-02
• Results First Submitted QC: 2016-11-02
• Results First Posted: 2016-12-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infanrix-IPV/Hib Group	Blood Sampling	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.
Infanrix hexa Group	Blood Sampling	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.

Primary Outcome Measures

Name	Time	Method
Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.	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).	At Day 0	Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Number of Subjects With Serious Adverse Events (SAEs).	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 Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).	At Day 0	A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).	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	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).	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-PRP.	At Day 0	Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).
Concentrations of Antibodies Against Anti-HBs.	At Day 0	Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇪 Örebro, Sweden