NCT00137930

Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis

Compare the Immunogenicity, Reactogenicity & Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine Given as a Two-dose Primary Vaccination in Healthy Infants Previously Uninfected With HRV

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative buffer, was developed. This study will be conducted to evaluate the new formulation compared to the existing formulation of the HRV vaccine.

Detailed description

The study consists of four groups of children recruited in different centers in Finland. One group of children will receive the existing formulation of HRV vaccine and one group will receive the new formulation of the HRV vaccine. The other two groups will receive the placebo for existing formulation or the new formulation based on the allocation. The vaccine or placebo will be administered starting at 6 - 12 weeks of age according to 0, 1 month schedule. Routine childhood vaccinations are allowed according to local practice, but at least 14 days apart from each dose of study vaccine. The duration of the study will be approximately 2 months per child.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated rotavirus vaccine

Timeline

• Start date: 2005-08-01
• Completion: 2005-11-01
• First posted: 2005-08-30
• Last updated: 2016-09-21

Locations

5 sites across 1 country: Finland