Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Haemophilus Influenzae Type b

Diphtheria

Whole Cell Pertussis

Tetanus

Hepatitis B

Treatments

Biological: DTPw-HBV/Hib-MenAC conjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00290303

100478

Details and patient eligibility

About

The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not carry hepatitis B virus) at 6, 10 & 14 weeks of age. This study will also include a small group of infants born to mothers who do carry hepatitis B virus; these infants will receive a birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6, 10 & 14 weeks age.

Full description

Randomized study with three groups (subjects born to mothers who do not carry hepatitis B virus) to receive one of the following vaccination regimens: - GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth

GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and no hepatitis B vaccine at birth - GSK Biologicals' Tritanrix™-HepB/Hiberix™ There will also be a fourth group (subjects born to mothers who do carry hepatitis B virus) to receive: - GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and hepatitis B vaccine at birth

Enrollment

996 patients

Sex

All

Ages

3+ days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Result of the maternal blood sample (presence/not of hepatitis B virus) is available.

Exclusion criteria

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (except for immunoglobulins given at birth to infants born to HBsAg seropositive mothers).
Acute disease at the time of enrolment.
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
Hepatitis B vaccine given at birth outside the study.