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

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

NCT00158756

104021

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)

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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