Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rotarix
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Oral live attenuated human rotavirus vaccine, Gastroenteritis, Vomiting
Eligibility Criteria
Inclusion Criteria:
- Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks).
- Written informed consent obtained from the parents or guardians of the subject.
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
- Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
- Household contact with an immunosuppressed individual or pregnant woman.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- Previous confirmed occurrence of RV GE.
Sites / Locations
Outcomes
Primary Outcome Measures
Occurrence of any RV GE
Secondary Outcome Measures
Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study),
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00429481
Brief Title
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
Official Title
Study to Assess Efficacy, Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at Different Viral Concentrations in Healthy Infants Previously Uninfected With Human Rotavirus and Approximately 3 Months of Age.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Oral live attenuated human rotavirus vaccine, Gastroenteritis, Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2464 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Rotarix
Primary Outcome Measure Information:
Title
Occurrence of any RV GE
Secondary Outcome Measure Information:
Title
Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study),
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Weeks
Maximum Age & Unit of Time
17 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks).
Written informed consent obtained from the parents or guardians of the subject.
Exclusion Criteria:
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
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.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Household contact with an immunosuppressed individual or pregnant woman.
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Previous confirmed occurrence of RV GE.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
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:
PubMed Identifier
15502699
Citation
De Vos B, Vesikari T, Linhares AC, Salinas B, Perez-Schael I, Ruiz-Palacios GM, Guerrero Mde L, Phua KB, Delem A, Hardt K. A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr Infect Dis J. 2004 Oct;23(10 Suppl):S179-82. doi: 10.1097/01.inf.0000142370.16514.4a.
Results Reference
background
PubMed Identifier
19289978
Citation
De Vos B, Han HH, Bouckenooghe A, Debrus S, Gillard P, Ward R, Cheuvart B. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis of randomized controlled trials. Pediatr Infect Dis J. 2009 Apr;28(4):261-6. doi: 10.1097/INF.0b013e3181907177.
Results Reference
background
PubMed Identifier
16088807
Citation
Phua KB, Quak SH, Lee BW, Emmanuel SC, Goh P, Han HH, De Vos B, Bock HL. Evaluation of RIX4414, a live, attenuated rotavirus vaccine, in a randomized, double-blind, placebo-controlled phase 2 trial involving 2464 Singaporean infants. J Infect Dis. 2005 Sep 1;192 Suppl 1:S6-S16. doi: 10.1086/431511.
Results Reference
background
PubMed Identifier
16470273
Citation
Phua KB, Emmanuel SC, Goh P, Quak SH, Lee BW, Han HH, Ward RL, Bernstein DI, De Vos B, Bock HL. A rotavirus vaccine for infants: the Asian experience. Ann Acad Med Singap. 2006 Jan;35(1):38-44.
Results Reference
background
PubMed Identifier
16600443
Citation
Phua KB, Quak SH, Emmanuel S, Goh PS, Han HH, Hardt K, Bock HL, De Vos B. A short report on highlights of worldwide development of RIX4414: a Singaporean experience. Vaccine. 2006 May 1;24(18):3782-3. doi: 10.1016/j.vaccine.2006.03.040. Epub 2006 Mar 23.
Results Reference
background
PubMed Identifier
18695765
Citation
Phua KB, Quak SH, Lim FS, Goh P, Teoh YL, Datta SK, Han HH, Bock HL. Immunogenicity, reactogenicity and safety of a diphtheria-tetanus-acellular pertussis-inactivated polio and Haemophilus influenzae type b vaccine in a placebo-controlled rotavirus vaccine study. Ann Acad Med Singap. 2008 Jul;37(7):546-53.
Results Reference
background
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
444563/007
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
444563/007
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
444563/007
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
444563/007
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
444563/007
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
We'll reach out to this number within 24 hrs