Status:
COMPLETED
To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-14 years
Phase:
PHASE3
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 ...
Detailed Description
This is a Phase 3b study. Each study group is further stratified into two sub-groups depending on the gestational age at birth of the subject: * Stratum I: very pre-term infants, born after a gestat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 25 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2008
Estimated Enrollment :
1009 Patients enrolled
Trial Details
Trial ID
NCT00420745
Start Date
January 25 2007
End Date
March 25 2008
Last Update
June 8 2018
Active Locations (31)
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1
GSK Investigational Site
Bondy, France, 93140
2
GSK Investigational Site
Bordeaux, France, 33076
3
GSK Investigational Site
Caen, France, 14033
4
GSK Investigational Site
Clermont-Ferrand, France, 63058