Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

Phase 3

Completed

• Conditions: Diphtheria; Hepatitis B; Poliomyelitis; Tetanus; Acellular Pertussis
• Interventions: Biological: Pediarix TM, Infanrix penta TM; Biological: Hiberix TM

• Registration Number: NCT00879827
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2001-05
• Study Completion: 2001-05
• Study First Submitted: 2009-04-09
• Study First Submitted QC: 2009-04-09
• Study First Posted: 2009-04-13
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Written informed consent obtained from the parents or guardians of the subject.
• Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
• Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
• Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
• History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• Major congenital defects
• Serious chronic illness
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Acute disease at the time of enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Group	Hiberix TM	-
Single Group	Pediarix TM, Infanrix penta TM	-

Primary Outcome Measures

Name	Time	Method
Anti-PT, anti-FHA and anti-PRN antibody titers.	One month after the 3rd dose of the primary vaccination course
Anti-HBs antibody titers	One month after the 3rd dose of the primary vaccination course
Anti-PRP antibody titers	One month after the 3rd dose of the primary vaccination course
Anti-polio virus types 1, 2 and 3 antibody titers	One month after the 3rd dose of the primary vaccination course
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers	One month after the 3rd dose of the primary vaccination course

Secondary Outcome Measures

Name	Time	Method
Occurrence of solicited adverse events	During the 4-day follow-up period after each dose
Occurrence of unsolicited adverse events	During the 30-day follow-up period after each dose
Occurrence of Serious Adverse Events	Over the course of the study