To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants
1 other identifier
interventional
1,009
4 countries
31
Brief Summary
This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study will be performed in four European countries (France, Poland, Spain, and Portugal). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2007
Shorter than P25 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedStudy Start
First participant enrolled
January 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2008
CompletedResults Posted
Study results publicly available
May 4, 2009
CompletedJune 8, 2018
November 1, 2016
1.1 years
January 9, 2007
March 13, 2009
May 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo
Secondary Outcomes (5)
Number of Subjects Reporting Unsolicited Adverse Events (AEs), According to Medical Dictionary for Regulatory Activities (MedDRA) Classification.
Within 31 days after any Rotarix vaccine/Placebo dose.
Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.
Within 15 days after each Rotarix vaccine/Placebo dose.
Number of Subjects for Whom Presence of Rotavirus (RV) Gastroenteritis (GE) Was Detected in Stools.
From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/Placebo
Seroconversion to Anti-rotavirus Immunoglobulin A (IgA) Antibody.
At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo
Serum Anti-Rotavirus IgA Antibody Concentration.
At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo
Study Arms (2)
Rotarix Group
EXPERIMENTALAll subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
Placebo Group
PLACEBO COMPARATORAll subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Healthy male or female infant between, and including, 6 and 14 weeks (42 - 104 days) of age at the time of first study vaccination in Portugal, France and Poland. A male or female infant between, and including, 6 and 12 weeks of age at the time of first study vaccination in Spain.
- Medically stable pre-term infants, born within a gestational period of 27 -36 weeks.
- Written informed consent obtained from the parent or guardian of the subject.
- Planned to be discharged from hospital's neonatal stay on or before the day of the first HRV vaccine/Placebo administration.
You may not qualify if:
- Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccines not foreseen by the study protocol from birth till study end.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Any clinically significant history of chronic gastrointestinal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness (subjects with severe broncho-pulmonary dysplasia requiring persistent oxygen-therapy will be excluded).
- History of any neurologic disorders or seizures. Grade I and II intra-ventricular bleeding are allowed.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the study period. Monoclonal anti-RSV therapy/prophylaxis and recombinant erythropoietin are allowed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (31)
GSK Investigational Site
Bondy, 93140, France
GSK Investigational Site
Bordeaux, 33076, France
GSK Investigational Site
Caen, 14033, France
GSK Investigational Site
Clermont-Ferrand, 63058, France
GSK Investigational Site
Lille, 59037, France
GSK Investigational Site
Lyon, 69437, France
GSK Investigational Site
Marseille, 13915, France
GSK Investigational Site
Paris, 75014, France
GSK Investigational Site
Bydgoszcz, 85-021, Poland
GSK Investigational Site
Dębica, 39-200, Poland
GSK Investigational Site
Krakow, 31-503, Poland
GSK Investigational Site
Lodz, 91-347, Poland
GSK Investigational Site
Mielec, 39-300, Poland
GSK Investigational Site
Poznan, 61-709, Poland
GSK Investigational Site
Siemianowice Śląskie, 41-103, Poland
GSK Investigational Site
Wroclaw, 50345, Poland
GSK Investigational Site
Amadora, 2720-276 Amadora, Portugal
GSK Investigational Site
Lisbon, 1069-089, Portugal
GSK Investigational Site
Lisbon, 1169-045 Lisboa, Portugal
GSK Investigational Site
Lisbon, 1449-005 Lisboa, Portugal
GSK Investigational Site
Porto, 4050-371 PORTO, Portugal
GSK Investigational Site
Almería, 04009, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Bilbao, 48013, Spain
GSK Investigational Site
Burgos, 09005, Spain
GSK Investigational Site
Fuenlabrada (Madrid), 28942, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28047, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Móstoles/Madrid, 28935, Spain
GSK Investigational Site
Valladolid, 47010, Spain
Related Publications (3)
Omenaca F, Sarlangue J, Szenborn L, Nogueira M, Suryakiran PV, Smolenov IV, Han HH; ROTA-054 Study Group. Safety, reactogenicity and immunogenicity of the human rotavirus vaccine in preterm European Infants: a randomized phase IIIb study. Pediatr Infect Dis J. 2012 May;31(5):487-93. doi: 10.1097/INF.0b013e3182490a2c.
PMID: 22228231BACKGROUNDOmenaca F et al. Immunogenicity of a rotavirus vaccine (RIX4414) in European pre-term infants with different gestational age. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
BACKGROUNDOmenaca F et al. Safety, Reactogenicity and Immunogenicity of RIX4414 Live Attenuated Human Rotavirus Vaccine in Pre-Term Infants. Abstract presented at the ICAAC/IDSA Joint Meeting, Washington DC, US, 25-28 October 2008.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2007
First Posted
January 11, 2007
Study Start
January 25, 2007
Primary Completion
March 1, 2008
Study Completion
March 25, 2008
Last Updated
June 8, 2018
Results First Posted
May 4, 2009
Record last verified: 2016-11
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.