To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2002-09-30

Brief Summary

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This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.

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Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Infanrix-Hexa

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female infant at the age of 11 - 17 weeks.
* Written informed consent obtained from the parents or guardians of the subject.
* Free of obvious health problems as established by clinical examination before entering into the study.
* Hepatitis B vaccine at birth and one month of age.

Exclusion Criteria

* Previous vaccination against measles, mumps, rubella and/or varicella.
* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
* Major congenital defects.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

Minimum Eligible Age

11 Weeks

Maximum Eligible Age

17 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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Lim FS, Han HH, Jacquet JM, Bock HL. Primary vaccination of infants against hepatitis B can be completed using a combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Haemophilus influenzae type B vaccine. Ann Acad Med Singap. 2007 Oct;36(10):801-6.

Reference Type BACKGROUND

PMID: 17987229 (View on PubMed)

Study Documents

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