Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine

GlaxoSmithKline121 enrolled

Overview

This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.

"There will be two groups in this study: * one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination * the control group will receive a birth dose of hepatitis B vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination".

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

121

Conditions

Hepatitis B

Interventions

DTPa-HBV-IPV/HibBIOLOGICAL

GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine

Eligibility

Sex: ALLMin age: 2 DaysMax age: 5 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria For the primary vaccination phase * Healthy newborn male or female infant 2 to 5 days old at the time of the first vaccination \& written informed consent taken from the parents/guardians of the subject * Born at term (gestational age 37-42 weeks) after an uncomplicated pregnancy * Birth weight \>= 2.5 kg and 5 minute Apgar \>= 7 * Mother seronegative for Hepatitis B surface antigen (HBsAg) For the booster vaccination phase * A healthy male or female between, and including, 12 and 23 months of age at the time of booster vaccination who has completed the primary vaccination course in the primary vaccination phase with written informed consent obtained from the parent or guardian of the subject Exclusion criteria For the primary vaccination phase * Mother known or suspected to be seropositive for HIV (testing not required for inclusion) * Planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study * Planned administration of immuno-suppressants or other immune-modifying drugs, administration of immunoglobulins and/or any blood products since birth or planned administration during the study. * Administration of immunoglobulins and/or any blood products to the mother during pregnancy * Neonatal jaundice requiring parenteral treatment (light therapy for physiological jaundice is allowed) * At risk of pneumococcal disease or planning to receive Prevenar™ during the study period * Administration or planned administration of BCG vaccination during the study period * Acute disease at the time of vaccination. For the booster vaccination phase * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose, or planned use during the booster phase. * Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination since the study conclusion visit of the primary vaccination phase. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * Administration/ planned administration of a vaccine not foreseen by the study protocol, administration/ planned administration of immunoglobulins and/or any blood products during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose."

Locations (1)

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Outcomes

Primary Outcomes

Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

Time frame: At Month 0

Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

Time frame: At Month 3

Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

Time frame: At Month 5

Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

Time frame: At Month 7

Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

Time frame: At Month 0

Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

Time frame: At Month 3

Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

Data from ClinicalTrials.gov

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Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

Time frame: At Month 5

Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

Time frame: At Month 7

Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

Time frame: At Month 1 Post-Booster

Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

Time frame: At Month 1 Post-Booster

Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.

Time frame: At Month 7

Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

Time frame: At Month 1 Post-Booster

Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Time frame: At Month 7

Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Time frame: At pre-booster vaccination (Month 0 BST)

Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Time frame: At Month 1 post-booster vaccination

Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

Time frame: At Month 7

Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

Time frame: At pre-booster vaccination (Month 0 BST)

Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

Time frame: At Month 1 post-booster vaccination

Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

Time frame: At Month 7

Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

Time frame: At pre-booster vaccination (Month 0 BST)

Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

Time frame: At Month 1 post-booster vaccination

Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

Time frame: At Month 7

Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

Time frame: At pre-booster vaccination (Month 0 BST)

Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

Time frame: At Month 1 post-booster vaccination

Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

Time frame: At Month 7

Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

Time frame: At pre-booster vaccination (Month 0 BST)

Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

Time frame: At Month 1 post-booster vaccination

Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

Time frame: At Month 7

Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

Time frame: At pre-booster vaccination (Month 0 BST)

Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

Time frame: At Month 1 post-booster vaccination

Number of subjects with solicited general symptoms

The solicited local symptoms assessed were Drowsiness, Temperature (Fever), Irritability and Loss of appetite. Temperature = Fever ≥ 38.0 °C. Grade 3 drowsiness = drowsiness that prevented normal activity; Grade 3 irritability = crying that could not be comforted/prevented normal activity; Grade 3 loss of appetite = not eating at all; Grade 3 Temperature = \> 39.5 °C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.

Time frame: During the 8-day (Day 0-Day 7) follow-up period after the any dose and booster vaccination

Number of subjects with unsolicited adverse events (AES)

An AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame: Occurring within Day 0-30 following primary and booster vaccination