NCT00420745

To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants

Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,009 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 14 Weeks
• Healthy volunteers: Accepted

Summary

This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study will be performed in four European countries (France, Poland, Spain, and Portugal). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

This is a Phase 3b study. Each study group is further stratified into two sub-groups depending on the gestational age at birth of the subject: * Stratum I: very pre-term infants, born after a gestational period of 27-30 weeks (189-216 days) (20% of enrolment). * Stratum II: mild pre-term infants born after a gestational period of 31-36 weeks (217-258 days) (80% of enrolment). The study will be conducted in a double-blind manner with respect to the HRV vaccine and placebo. The study will not be blinded with respect to the type of concomitantly administered routine infant vaccination. In accordance with the local National Plan of Immunisation schedule in each of the respective participating countries, GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib), Infanrix Quinta™ (DTPa-IPV-Hib), Infanrix™+IPV+Hib (DTPa+IPV+Hib) and/or Engerix-B™ (HBV) will be co-administered (at a maximum interval of two days from each other) with each HRV vaccine or placebo dose. Hepatitis B and Bacille Calmette-Guérin vaccines (BCG) at birth are allowed if included in the local National Plan of Immunisation schedule in participating countries. At the discretion of the investigator the following vaccines may be administered during each subject's study participation: * Vaccine against Streptococcus pneumoniae (Prevenar®) in France and Spain (concomitantly with HRV vaccine/Placebo). * Vaccine against Neisseria meningitidis (Neis Vacc C®) is allowed if there is at least 14-days interval with respect to the administration of the HRV vaccine/Placebo.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
BIOLOGICAL	Rotarix™	Two-dose oral vaccination.
BIOLOGICAL	Placebo	Two-dose oral administration

Timeline

• Start date: 2007-01-25
• Primary completion: 2008-03-01
• Completion: 2008-03-25
• First posted: 2007-01-11
• Last updated: 2018-06-08
• Results posted: 2009-05-04

Locations

31 sites across 4 countries: France, Poland, Portugal, Spain