Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Rotavirus

Treatments: Biological: Placebo (primary vaccination study); Biological: Rotarix (primary vaccination study)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420316

109810

Details and patient eligibility

About

To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.

Enrollment: 1,613 patients

Sex: All

Ages: 32 months to 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
• Written informed consent obtained from the parent or guardian of the subject.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,613 participants in 2 patient groups, including a placebo group

Rotarix Group

Experimental group

Description:

Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

Treatment:

Biological: Rotarix (primary vaccination study)

Placebo Group

Placebo Comparator group

Description:

Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

Treatment:

Biological: Placebo (primary vaccination study)