search
Back to results

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

Primary Purpose

Rotavirus Gastroenteritis

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Live attenuated human rotavirus vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotavirus Gastroenteritis

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Percentage of subjects with vaccine take

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)
Evaluation of the serum anti-RV IgA (immunoglobulin A) antibody concentrations expressed as Geometric Mean Concentrations (GMC)
Rotavirus antigen shedding in planned stool samples
Presence of RV in gastroenteritis (GE) episode stools collected
For each type of solicited symptoms, occurrence of the symptom
Occurrence of any Grade 2 or Grade 3 fever, vomiting or diarrhea
Occurrence of unsolicited adverse events (AEs) according to Medical Dictionary for Regulatory Activities (MedDRA) classification
Occurrence of serious adverse events (SAEs) according to MedDRA classification

Full Information

First Posted
September 9, 2005
Last Updated
January 13, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00169455
Brief Title
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
Official Title
A Phase IIIb, Partially Blind, Randomized, Placebo-controlled Study to Asses the Effect on Immunogenicity of Administration of Vaccine Without Buffering Agent and to Assess Heat Stability in Terms of Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Following a 0, 2 Month Schedule, in Healthy Infants Previously Uninfected With Human Rotavirus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Gastroenteritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Live attenuated human rotavirus vaccine
Primary Outcome Measure Information:
Title
Percentage of subjects with vaccine take
Time Frame
At 2 months post-Dose 2
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Rotavirus antigen shedding in planned stool samples
Time Frame
At Day 0, Day 7 and Day 15 post each study vaccine dose
Title
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
Title
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
Title
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
Title
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
Title
Occurrence of serious adverse events (SAEs) according to MedDRA classification
Time Frame
Throughout the study period (Day 0 to Month 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
20220306
Citation
Kerdpanich A, Chokephaibulkit K, Watanaveeradej V, Vanprapar N, Simasathien S, Phavichitr N, Bock HL, Damaso S, Hutagalung Y, Han HH. Immunogenicity of a live-attenuated human rotavirus RIX4414 vaccine with or without buffering agent. Hum Vaccin. 2010 Mar 26;6(3):10428. doi: 10.4161/hv.6.3.10428. Epub 2010 Mar 26.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
21228629
Citation
Kerdpanich A, Chokephaibulkit K, Watanaveeradej V, Vanprapar N, Simasathien S, Phavichitr N, Bock HL, Damaso S, Hutagalung Y, Han HH. Immunogenicity of a human rotavirus vaccine (RIX4414) after storage at 37 degrees C for seven days. Hum Vaccin. 2011 Jan 1;7(1):74-80. doi: 10.4161/hv.7.1.13412. Epub 2011 Jan 1.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103477
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103477
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103477
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103477
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103477
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103477
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

We'll reach out to this number within 24 hrs