Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Haemophilus Influenzae Type b; Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: Infanrix™-IPV+Hib; Biological: Synflorix™; Biological: Infanrix™ IPV; Biological: Rotarix™; Biological: Hiberix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01309646

114260

2012-004137-16 (EudraCT Number)

Details and patient eligibility

About

This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.

Enrollment: 454 patients

Sex: All

Ages: 42 to 69 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A male or female between, and including, 42 and 69 days of age at the time of the first vaccination.
• Born after a gestation period of 37 to 42 weeks inclusive.
• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccination or disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Acute disease and/or fever at the time of enrolment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

454 participants in 2 patient groups

Infanrix-IPV+Hib Group

Experimental group

Description:

Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.

Treatment:

Biological: Rotarix™

Biological: Synflorix™

Biological: Infanrix™-IPV+Hib

Infanrix IPV Group

Active Comparator group

Description:

Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.

Treatment:

Biological: Infanrix™ IPV

Biological: Rotarix™

Biological: Hiberix™

Biological: Synflorix™