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

Phase 2

Completed

• Conditions: Hepatitis B
• Interventions: Biological: DTPa-HBV-IPV/Hib

• Registration Number: NCT00289796
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

"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".

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Primary Completion: 2006-04
• Study Completion: 2006-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infanrix hexa Group	DTPa-HBV-IPV/Hib	Subjects received a dose of hepatitis B vaccine at birth followed by immunization with 3 doses of Infanrix hexa™ (2, 4 and 6 months of age) and one booster dose of Infanrix hexa™ between 12 and 23 months of age. All vaccines were administered by deep intramuscular injection into the left anterolateral thigh.

Primary Outcome Measures

Name	Time	Method
Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)	At Month 1 post-booster vaccination	A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.
Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)	At Month 1 post-booster vaccination	Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.
Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies	At Month 1 post-booster vaccination	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies	At Month 1 post-booster vaccination	Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.
Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies	At Month 1 post-booster vaccination	Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies	At Month 1 Post-Booster	Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies	At Month 1 Post-Booster	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.
Number of subjects with solicited general symptoms	During the 8-day (Day 0-Day 7) follow-up period after the any dose and booster vaccination	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.
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies	At Month 1 Post-Booster	A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies	At Month 1 post-booster vaccination	A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Number of subjects with unsolicited adverse events (AES)	Occurring within Day 0-30 following primary and booster vaccination	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Mainz, Rheinland-Pfalz, Germany