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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2001-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diphtheria Poliomyelitis Hepatitis B Tetanus Acellular Pertussis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Single Group

Group Type EXPERIMENTAL

Pediarix TM, Infanrix penta TM

Intervention Type BIOLOGICAL

The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

Hiberix TM

Intervention Type BIOLOGICAL

The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

Interventions

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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.

Intervention Type BIOLOGICAL

Hiberix TM

The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes