Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.
1 other identifier
interventional
529
0 countries
N/A
Brief Summary
This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2000
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 4, 2008
CompletedFirst Posted
Study publicly available on registry
August 6, 2008
CompletedSeptember 16, 2016
September 1, 2016
1.8 years
August 4, 2008
September 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of subjects with vaccine take
Two months after the second dose
Occurrence of any grade 2 or 3 fever, vomiting or diarrhea
Within the 15-day solicited follow-up period after any dose of study vaccine.
Secondary Outcomes (12)
Occurrence of each type of solicited symptoms
Within the 15-day solicited follow-up period after any dose of study vaccine
Occurrence of unsolicited symptoms according to WHO classification.
Within 42 days after dose 1 and dose 2
Occurrence of serious adverse events
Throughout the entire study period
Serum rotavirus immunoglobulin A (IgA) antibody titers
At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
Rotavirus seropositivity status
Before dose 1 and at the end of the study
- +7 more secondary outcomes
Study Arms (3)
Group A
EXPERIMENTALHuman Rotavirus Vaccine - Formulation 1
Group B
EXPERIMENTALHuman Rotavirus Vaccine - Formulation 2
Group C
PLACEBO COMPARATORInterventions
Three-dose intramuscular injection (US subjects only)
Eligibility Criteria
You may qualify if:
- A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
You may not qualify if:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the 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 since birth.
- Use of antibiotics within 7 days preceding dose 1.
- 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 human immunodeficiency virus (HIV) infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrollment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Household contact with an immunosuppressed individual or pregnant women.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- Previous confirmed occurrence of rotavirus gastroenteritis.
- Inability to contact parents/guardians of the subject by telephone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (2)
Dennehy PH; North American Human Rotavirus Vaccine Study Group. A short report on the highlights of world-wide development of RIX4414: a North American experience comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine (RIX4414) in infants in the United States and Canada. Vaccine. 2006 May 1;24(18):3780-1. doi: 10.1016/j.vaccine.2005.07.030. Epub 2005 Aug 1.
PMID: 16111790BACKGROUNDDennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer FH Jr, Innis BL, Rathfon H, Schuind A, De Vos B; North American Human Rotavirus Vaccine Study Group. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infect Dis J. 2005 Jun;24(6):481-8. doi: 10.1097/01.inf.0000164763.55558.71.
PMID: 15933555BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2008
First Posted
August 6, 2008
Study Start
November 1, 2000
Primary Completion
September 1, 2002
Study Completion
September 1, 2002
Last Updated
September 16, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.