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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Hepatitis B

Treatments

Biological: Tritanrix™-HepB
Biological: Zilbrix™
Drug: Placebo
Biological: Rotarix™
Biological: Engerix™-B
Biological: Triple Antigen™

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full description

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

Enrollment

308 patients

Sex

All

Ages

3 weeks to 4 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

308 participants in 5 patient groups

Tritanrix™-HepB+Rotarix™ Group
Experimental group
Description:
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.
Treatment:
Biological: Rotarix™
Biological: Tritanrix™-HepB
Tritanrix™-HepB+Placebo Group
Experimental group
Description:
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.
Treatment:
Drug: Placebo
Biological: Tritanrix™-HepB
Zilbrix™+Rotarix™ Group
Active Comparator group
Description:
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.
Treatment:
Biological: Rotarix™
Biological: Zilbrix™
Zilbrix™+Placebo Group
Active Comparator group
Description:
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.
Treatment:
Drug: Placebo
Biological: Zilbrix™
Triple Antigen™+Engerix™-B Group
Active Comparator group
Description:
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.
Treatment:
Biological: Triple Antigen™
Biological: Engerix™-B

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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