To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Rotavirus

Treatments: Biological: Lyophilized formulation of HRV vaccine; Biological: Liquid formulation of HRV vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00363545

107077

Details and patient eligibility

About

This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine

Enrollment: 1,274 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
• Written informed consent obtained from the parent or guardian of the subject.

Exclusion criteria

• se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
• 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 (pharmaceutical product or device).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Household contact with an immunosuppressed individual or pregnant women.
• Previous confirmed occurrence of RV GE.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,274 participants in 2 patient groups

Liquid Rotarix Group

Experimental group

Description:

Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.

Treatment:

Biological: Liquid formulation of HRV vaccine

Lyophilized Rotarix Group

Experimental group

Description:

Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.

Treatment:

Biological: Lyophilized formulation of HRV vaccine