NCT02914184

Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,612 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.

Detailed description

* Experimental design: Phase IIIA, observer-blind, randomised (1:1:1:1), controlled, multi-centric, with four parallel groups and a staggered enrolment (Part A and Part B). * Duration of the study: The intended duration of the study, per subject, will be approximately 7-8 months including the 6 months of extended safety follow-up period after the last dose of HRV vaccine. * Epoch 001: Primary starting at Visit 1 (Day 0) and ending at the safety follow-up contact (Month 7-8). * Primary completion Date (PCD): Visit 3 (Month 2-4). * End of Study (EoS): Last testing results released of samples collected at Visit 3 or Last Subject Last Visit (LSLV) (Follow up contact at month 7-8). * Study Groups: * PCV-free HRV liquid formulation lot A (also referred to as Liq\_A Group) * PCV-free HRV liquid formulation lot B (also referred to as Liq\_B Group) * PCV-free HRV liquid formulation lot C (also referred to as Liq\_C Group) * GSK Biologicals' currently licensed lyophilised HRV formulation (also referred to as Lyo Group) * Control:active control-GSK Biologicals' currently licensed lyophilised HRV vaccine * Vaccination schedule: Two doses of HRV vaccine to be administered according to a 0, 1-2 month schedule according to the immunisation schedule for RV vaccine. Note that as a result of internal change in data standards terminology, the study data collected was converted to cDISC and the statistical analysis plan was amended accordingly. "Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by "Day n+1". Thus, the time frames (Day 0, Day n) of Outcome Measures described in this study record are different to that denoted in the full protocol document posted.

Conditions

• Infections, Rotavirus
• Rotavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	HRV PCV-free liquid vaccine	Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally
BIOLOGICAL	Rotarix	Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally

Timeline

• Start date: 2016-10-27
• Primary completion: 2018-06-27
• Completion: 2018-11-26
• First posted: 2016-09-26
• Last updated: 2020-07-21
• Results posted: 2019-10-14

Locations

66 sites across 8 countries: United States, Costa Rica, Finland, Germany, Japan, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study