Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Rotavirus

Treatments: Biological: Placebo; Biological: Rotarix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00757770

444563/033

Details and patient eligibility

About

The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.

Enrollment: 854 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 6 and 12 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.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Child is unlikely to remain in the study area for the duration of the study.
• Previous confirmed occurrence of rotavirus gastroenteritis.
• Gastroenteritis within 7 days preceding the study vaccine administration.
• Household contact with an immunosuppressed individual or pregnant woman.
• Use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s).
• Planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• Acute disease at time of enrollment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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854 participants in 4 patient groups

Group HRV Lot A

Experimental group

Treatment:

Biological: Rotarix

Group HRV Lot B

Experimental group

Treatment:

Biological: Rotarix

Group HRV Lot C

Experimental group

Treatment:

Biological: Rotarix

Group Placebo

Active Comparator group

Treatment:

Biological: Placebo