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

GlaxoSmithKline58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).

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)

Time frame: At Day 0

Concentrations of Antibodies Against Anti-D and Anti-T

Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).

Time frame: At Day 0

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).

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.

Time frame: At Day 0

Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).

Time frame: At Day 0

Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).

Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).

Time frame: At Day 0

Concentrations of Antibodies Against Anti-HBs.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).

Time frame: At Day 0

Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).

A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)

Time frame: At Day 0

Concentrations of Antibodies Against Anti-PRP.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).

Time frame: At Day 0

Number of Subjects With Serious Adverse Events (SAEs).

Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time frame: During the entire study period (up to Day 46)

Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL

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.

Time frame: At Day 0

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes