Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Poliomyelitis

Haemophilus Influenzae Type b

Diphtheria

Tetanus

Hepatitis B

Acellular Pertussis

Treatments

Biological: DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)

Biological: DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01457547

217744/094

Details and patient eligibility

About

The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.

Enrollment

494 patients

Sex

All

Ages

8 to 15 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A healthy male or female subject between 8 and 15 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Born after a normal gestation period between 36 and 42 weeks.

Exclusion criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib vaccination or disease.
Planned administration of a vaccine not foreseen by the study protocol since birth and during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose of the three-dose primary vaccination course, with the exception of licensed Neisseria meningitides conjugate vaccines or Bacillus Calmette-Guérin (BCG) vaccine that can be given in between study visits or after the third visit, provided they are given preferably with a 4 weeks interval but not less than 3 weeks apart from the study vaccine doses.
Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs since birth.
Planned administration of immunoglobulins and/or any blood products since birth or planned administration during the period up to 30 days after the third dose of the primary vaccination course.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
History of seizures, progressive neurological disease or intra-cerebral haemorrhage.
Major congenital defects or serious chronic illness.
Acute febrile illness at the time of planned vaccination
History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.