Status:
COMPLETED
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-14 years
Phase:
PHASE3
Brief Summary
The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
Detailed Description
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-14 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy infants 6 -14 weeks of age at the time of the first study vaccination with birth weight \> 2000g whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- Exclusion criteria:
- Use of any investigational or non-registered product (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.
- Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after.
- Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are allowed.)
- History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B disease (in all subjects). Only for subjects in Spain: history of meningococcal group C disease. Only for subjects in France and Germany: history of disease caused by Streptococcus pneumoniae.
- History of use of experimental rotavirus vaccine.
- Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (in all subjects). Only for subjects in Spain: previous vaccination against meningococcal group C. Only for subjects in France and Germany: previous vaccination against Streptococcus pneumoniae.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract, IS or other medical condition determined to be serious by the investigator.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F) / Axillary temperature \<37.5°C (99.5°F) / Rectal temperature \<38°C (100.4°F).)
- Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination).
- A family history of congenital or hereditary immunodeficiency.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- History of any neurologic disorders or seizures.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
3994 Patients enrolled
Trial Details
Trial ID
NCT00140686
Start Date
September 1 2004
End Date
August 1 2006
Last Update
March 23 2017
Active Locations (101)
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1
GSK Investigational Site
Brno, Czechia, 628 00
2
GSK Investigational Site
Havlíčkův Brod, Czechia, 580 22
3
GSK Investigational Site
Hradec Králové, Czechia, 500 02
4
GSK Investigational Site
Humpolec, Czechia, 396 01