Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Haemophilus Influenzae Type b; Diphtheria; Whole Cell Pertussis; Hepatitis B; Tetanus

Treatments: Biological: Zilbrix-Hib; Biological: Tritanrix™-HepB/ Hiberix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00473668

104977

Details and patient eligibility

About

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 300 patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of 36 to 42 weeks inclusive.
• Administration of one dose of hepatitis B vaccine at birth

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 with the exception of OPV.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV).
• Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
• Hepatitis B vaccine received after the first week of life.
• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth).
• History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B diseases.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
• 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: Triple Blind

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300 participants in 3 patient groups

TRITANRIX-HEPB/HIBERIX KFT. GROUP

Experimental group

Description:

Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.

Treatment:

Biological: Zilbrix-Hib

TRITANRIX-HEPB/HIBERIX LD GROUP

Active Comparator group

Description:

Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.

Treatment:

Biological: Tritanrix™-HepB/ Hiberix™

TRITANRIX-HEPB/HIBERIX HD GROUP

Active Comparator group

Description:

Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age.

Treatment:

Biological: Tritanrix™-HepB/ Hiberix™