Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Poliomyelitis

Haemophilus Influenzae Type b

Diphtheria

Tetanus

Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines

Acellular Pertussis

Treatments

Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00325156

2015-001512-35 (EudraCT Number)

100917

Details and patient eligibility

About

To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Full description

Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months

Enrollment

2,590 patients

Sex

All

Ages

11 to 17 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Subjects must have been enrolled in the Rota-028 study.
A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

Exclusion criteria

Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or 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.