Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

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

PHASE2

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

1999-09-30

Brief Summary

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This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.

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Detailed Description

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Conditions

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Hepatitis B Diphtheria Haemophilus Influenzae Type b (Hib) Poliomyelitis Pertussis Tetanus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DTPa 1 Group

Group Type EXPERIMENTAL

DTPa-HBV-IPV/Hib (Infanrix-hexa™)

Intervention Type BIOLOGICAL

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

DTPa 2 Group

Group Type ACTIVE_COMPARATOR

DTPa-IPV/Hib (Infanrix-IPV/Hib™)

Intervention Type BIOLOGICAL

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

HBV (Engerix™-B)

Intervention Type BIOLOGICAL

3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

Interventions

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DTPa-HBV-IPV/Hib (Infanrix-hexa™)

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

Intervention Type BIOLOGICAL

DTPa-IPV/Hib (Infanrix-IPV/Hib™)

3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8

Intervention Type BIOLOGICAL

HBV (Engerix™-B)

3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female between 12 and 16 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 after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

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 immune-modifying drugs during the study period.
* Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
* History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
* Major congenital defects or serious chronic illness.
* Progressive neurological disorders.
* Administration of immunoglobulins and/or any blood products since birth and during the study period.
* Acute febrile illness at the time of planned vaccination.

Minimum Eligible Age

12 Weeks

Maximum Eligible Age

16 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes