Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants

Phase 3

Completed

• Conditions: Rotavirus Gastroenteritis

• Registration Number: NCT00169455
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring 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. GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis. In this study, the immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or reconstituted in circumstances different from the recommendations: i.e. when not reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In addition, the effect of feeding will be explored for HRV vaccine reconstituted without buffer.

Detailed Description

Assess the effect on immunogenicity of administration of vaccine without buffering agent \& assess heat stability in terms of immunogenicity, reactogenicity \& safety of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine following a 0,2 m schedule, in healthy infants previously uninfected with human rotavirus

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with vaccine take	At 2 months post-Dose 2

Secondary Outcome Measures

Name	Time	Method
Occurrence of unsolicited adverse events (AEs) according to Medical Dictionary for Regulatory Activities (MedDRA) classification	Within 31 days (Day 0-30) after each study vaccine dose
Percentage of subjects who seroconverted (percentage of subjects with concentrations ≥ 20 U/mL in subjects who were negative for rotavirus (RV) before vaccination)	At 2 months post-Dose 2
Evaluation of the serum anti-RV IgA (immunoglobulin A) antibody concentrations expressed as Geometric Mean Concentrations (GMC)	At 2 months post-Dose 2
Rotavirus antigen shedding in planned stool samples	At Day 0, Day 7 and Day 15 post each study vaccine dose
Presence of RV in gastroenteritis (GE) episode stools collected	From Dose 1 of HRV vaccine/placebo up to 2 months post-Dose 2
For each type of solicited symptoms, occurrence of the symptom	Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose
Occurrence of any Grade 2 or Grade 3 fever, vomiting or diarrhea	Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose
Occurrence of serious adverse events (SAEs) according to MedDRA classification	Throughout the study period (Day 0 to Month 4)

Trial Locations

Locations (1)

GSK Investigational Site; 🇹🇭 Bangkok, Thailand