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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: September 9, 2005
Last updated: November 20, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Rotavirus Gastroenteritis
Biological: Live attenuated human rotavirus vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: See Detailed Description

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage of subjects with vaccine take [ Time Frame: At 2 months post-Dose 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects who seroconverted (percentage of subjects with concentrations ≥ 20 U/mL in subjects who were negative for rotavirus (RV) before vaccination) [ Time Frame: At 2 months post-Dose 2 ] [ Designated as safety issue: No ]
  • Evaluation of the serum anti-RV IgA (immunoglobulin A) antibody concentrations expressed as Geometric Mean Concentrations (GMC) [ Time Frame: At 2 months post-Dose 2 ] [ Designated as safety issue: No ]
  • Rotavirus antigen shedding in planned stool samples [ Time Frame: At Day 0, Day 7 and Day 15 post each study vaccine dose ] [ Designated as safety issue: No ]
  • Presence of RV in gastroenteritis (GE) episode stools collected [ Time Frame: From Dose 1 of HRV vaccine/placebo up to 2 months post-Dose 2 ] [ Designated as safety issue: No ]
  • For each type of solicited symptoms, occurrence of the symptom [ Time Frame: Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of any Grade 2 or Grade 3 fever, vomiting or diarrhea [ Time Frame: Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events (AEs) according to Medical Dictionary for Regulatory Activities (MedDRA) classification [ Time Frame: Within 31 days (Day 0-30) after each study vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events (SAEs) according to MedDRA classification [ Time Frame: Throughout the study period (Day 0 to Month 4) ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: March 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes


  • A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.


  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose, since birth. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
  • Planned administration of a vaccine (except routine paediatric vaccines) not foreseen by the study protocol. (If exceptionally OPV is given, this should be administered at least 14 days apart from the HRV vaccine or placebo dose.)
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
  • Major congenital defects or serious chronic illness.
  • Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins via e.g. breastfeeding is allowed.
  • Previous confirmed occurrence of RV gastroenteritis.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00169455

GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10700
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Kerdpanich A et al. Feeding does not influence the immunogenicity of RIX4414 (Rotarix") in Thailand. Abstract presented at the 5th World Congress of the World Society for Pediatric infectious Diseases ( WSPID). Bangkok, Thailand, 15-18 November 2007.
Debrus S et al. Study of the viral activity of RIX4414 - human rotavirus vaccine. Abstract presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Chicago, USA, 17-20 September 2007.
Kerdpanich et al. Exposure to elevated temperature of 37°C for 7 days does not affect immunogenicity and reactogenicity of RIX4414. Abstract presented at the 9th dsRNA Virus Meeting. Cape Town, South Africa, 21-26 October 2006.
Chokephaibulkit K et al. Immunogenicity And Vaccine Take Of RIX4414 (Rotarix") After Heat Exposure. Abstract presented at the 5th World Congress of the World Society for Pediatric infectious Diseases (WSPID). Bangkok, Thailand, 15-18 November 2007.
Debrus S et al. Viral shedding (methodology). Abstract presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Chicago, USA, 17-20 September 2007.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00169455     History of Changes
Other Study ID Numbers: 103477
Study First Received: September 9, 2005
Last Updated: November 20, 2015
Health Authority: Thailand: Ministry of Public Health

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases processed this record on November 27, 2015