Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-12

Study Completion Date

2006-11-23

Brief Summary

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To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.

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Detailed Description

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Randomized study with five groups to receive one of the following vaccination regimens:

One of the two formulations of GSK Biologicals' DTPw-HBV + GSK Biologicals' HRV One of the two formulations of GSK Biologicals' DTPw-HBV + Placebo CSL's DTPw + GSK Biologicals' HBV

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

Study Groups

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Tritanrix™-HepB+Rotarix™ Group

Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.

Group Type EXPERIMENTAL

Tritanrix™-HepB

Intervention Type BIOLOGICAL

GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.

Rotarix™

Intervention Type BIOLOGICAL

GSK Biologicals' live attenuated human rotavirus vaccine

Tritanrix™-HepB+Placebo Group

Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.

Group Type EXPERIMENTAL

Tritanrix™-HepB

Intervention Type BIOLOGICAL

GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.

Placebo

Intervention Type DRUG

Placebo for the Rotarix™ vaccine

Zilbrix™+Rotarix™ Group

Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.

Group Type ACTIVE_COMPARATOR

Rotarix™

Intervention Type BIOLOGICAL

GSK Biologicals' live attenuated human rotavirus vaccine

Zilbrix™

Intervention Type BIOLOGICAL

GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine

Zilbrix™+Placebo Group

Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.

Group Type ACTIVE_COMPARATOR

Zilbrix™

Intervention Type BIOLOGICAL

GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine

Placebo

Intervention Type DRUG

Placebo for the Rotarix™ vaccine

Triple Antigen™+Engerix™-B Group

Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.

Group Type ACTIVE_COMPARATOR

Triple Antigen™

Intervention Type BIOLOGICAL

Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.

Engerix™-B

Intervention Type BIOLOGICAL

GSK Biologicals' hepatitis B vaccine

Interventions

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Tritanrix™-HepB

GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.

Intervention Type BIOLOGICAL

Rotarix™

GSK Biologicals' live attenuated human rotavirus vaccine

Intervention Type BIOLOGICAL

Zilbrix™

GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine

Intervention Type BIOLOGICAL

Triple Antigen™

Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.

Intervention Type BIOLOGICAL

Engerix™-B

GSK Biologicals' hepatitis B vaccine

Intervention Type BIOLOGICAL

Placebo

Placebo for the Rotarix™ vaccine

Intervention Type DRUG

Other Intervention Names

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DTPw-HBV HRV vaccine DTPw-HBV Kft DTPwcsl vaccine HBV vaccine

Eligibility Criteria

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Inclusion Criteria

* Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
* Administration of one dose of hepatitis B vaccine at birth.
* A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Minimum Eligible Age

3 Weeks

Maximum Eligible Age

4 Months

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

Locations

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GSK Investigational Site

Barnaul, , Russia

Site Status

GSK Investigational Site

Ivanteevka Moscow Region, , Russia

Site Status

GSK Investigational Site

Krasnoyarsk, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Samara, , Russia

Site Status

GSK Investigational Site

Tomsk, , Russia

Site Status

GSK Investigational Site

Yekaterinburg, , Russia

Site Status

Countries

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Russia

Study Documents

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