Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Hepatitis B

Treatments

Biological: DTPa-IPV/Hib vaccine

Biological: DTPa-HBV-IPV/Hib vaccine

Biological: EngerixTM-B

Study type

Interventional

Funder types

Industry

Identifiers

NCT00880477

217744/069

Details and patient eligibility

About

This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course and as a booster dose in infants born to hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV vaccine.

Enrollment

140 patients

Sex

All

Ages

6 to 8 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria for enrolment at birth

Written informed consent obtained from the parents or guardians of the subject.
A male or female infant born after a normal gestation period (between 36 and 42 weeks).
Born to a mother seronegative for HBsAg.
Free of obvious health problems as established by clinical examination before entering into the study.

Inclusion criteria for administration of the combined vaccine regimen

Between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study.

Inclusion criteria for administration of the booster dose

Between, and including, 15 and 18 months of age at the time of the booster vaccination.
Written informed consent obtained from the parents or guardians of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Completion of the three-dose primary vaccination course.

Exclusion criteria

Exclusion criteria for enrolment at birth

A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
Major congenital defect(s).

Exclusion criteria for administration of the combined vaccine regimen

Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration Immunosuppressants or other immune-modifying drugs since birth.
Any chronic drug therapy to be continued during the study period.
Planned administration/ administration of a vaccine except Bacille Calmette-Guérin vaccine during the period starting from 30 days before each dose of vaccines and ending 30 days after.
Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease.
History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Haemophilus influenzae type b disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Exclusion criteria for administration of the booster dose

Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months of vaccination.
Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrolment.
History of any neurologic disorders or seizures.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose of study vaccine or planned administration during the study period.
Hypersensitivity reaction due to vaccine in primary course
Encephalopathy within 7 days of previous vaccination with DTP vaccine