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

Purpose

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.

Condition	Intervention	Phase
Diphtheria Tetanus Whooping Cough Hepatitis B Poliovirus Haemophilus Influenzae Type b Disease	Biological: Hiberix TM Biological: Pediarix TM, Infanrix penta TM	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-Dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months

Resource links provided by NLM:

MedlinePlus related topics: Cough Diphtheria Flu Hepatitis Hepatitis A Hepatitis B Tetanus Whooping Cough

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-PT, anti-FHA and anti-PRN antibody titers. [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]
Anti-HBs antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]
Anti-polio virus types 1, 2 and 3 antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]
Anti-PRP antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of solicited adverse events [ Time Frame: During the 4-day follow-up period after each dose ] [ Designated as safety issue: No ]
Occurrence of unsolicited adverse events [ Time Frame: During the 30-day follow-up period after each dose ] [ Designated as safety issue: No ]
Occurrence of Serious Adverse Events [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	September 2000
Study Completion Date:	May 2001
Primary Completion Date:	May 2001 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single Group	Biological: Hiberix TM The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age. Biological: Pediarix TM, Infanrix penta TM The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

Eligibility

Ages Eligible for Study:	6 Weeks to 8 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879827

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00879827 History of Changes
Other Study ID Numbers:	217744/049
Study First Received:	April 9, 2009
Last Updated:	April 9, 2009
Health Authority:	Taiwan: Department of Health

Additional relevant MeSH terms:

Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Tetanus
Whooping Cough
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human

Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Infection

ClinicalTrials.gov processed this record on May 22, 2013