Last updated: 11/03/2018 09:04:03
To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Timeframe: From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo
Secondary outcomes:
Number of Subjects Reporting Unsolicited Adverse Events (AEs), according to Medical Dictionary for Regulatory Activities (MedDRA) classification.
Timeframe: Within 31 days after any Rotarix vaccine/Placebo dose.
Number of subjects for whom each type of solicited symptom was reported.
Timeframe: Within 15 days after each Rotarix vaccine/Placebo dose.
Number of subjects for whom presence of rotavirus (RV) gastroenteritis (GE) was detected in stools.
Timeframe: From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/Placebo
Seroconversion to anti-rotavirus Immunoglobulin A (IgA) antibody.
Timeframe: At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo
Serum anti–rotavirus IgA antibody concentration.
Timeframe: At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo
Interventions:
Biological/vaccine: Rotarix™
Biological/vaccine: Placebo
Enrollment:
1009
Observational study model:
Not applicable
Primary completion date:
2008-25-03
Time perspective:
Not applicable
Clinical publications:
Omenaca F et al. (2012) Safety, reactogenicity and immunogenicity of the human rotavirus vaccine in preterm European infants: a randomized phase IIIb study. Pediatr Infect Dis J. 31(5):487-493.
Omenaca 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.
Omenaca 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.
Buyse H et al. (2014) The human rotavirus vaccine Rotarix™ in infants: An integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 10(1):19-24.
Han HH et al. (2017) Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis. Hum Vaccin Immunother. 3(1):237-244.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
January 2007 to March 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 14 weeks
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-25-03
Actual study completion date
2008-25-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website