Status:
COMPLETED
Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children
Lead Sponsor:
National Institute of Hygiene and Epidemiology, Vietnam
Conditions:
Diarrhea
Fever
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of Vaccines and Biologic...
Detailed Description
The investigators evaluate the vaccine schedule consisting of 2 doses of Rotavin-M1, 10e6.3ffu/dose at 2 month interval in children in two study sites, Thanh Son- Phu Tho and Thai Binh city-Thai Binh ...
Eligibility Criteria
Inclusion
- At study entry
- A healthy male or female, 6 to 12 weeks of age (42 days to 84 days of age).
- Full term gestation (\>=37 weeks).
- Birth weight of the subject should be \>=2.5 kg.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Did not use any dose of Rota virus vaccine.
- Written informed consent obtained from the parent or guardian of the subject.
- At dose 2
- Received dose 1.
- Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.
Exclusion
- At study entry
- Has a chronic disease (cardiovascular, liver, kidney disease).
- Acute disease at the time of enrolment.
- Administering corticosteroids (\> 1mg/kg/day).
- Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
- Immunosuppressive or immunodeficient condition.
- Family has immunosuppressive or immunodeficient condition medical history.
- History of high fever convulsion.
- Allergic or reaction with any component of vaccine, includes anaphylactic shock with any antibiotic.
- Preterm of gestation delivery (gestation period \< 37 weeks).
- Low birth weight (\<2.5 kg).
- Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
- Malnutrition.
- Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
- Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- At dose 2
- Acute disease at the time of 2nd dose.
- Administering corticosteroids (\> 1mg/kg/day).
- Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
- Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
- Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
- Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
799 Patients enrolled
Trial Details
Trial ID
NCT01502969
Start Date
May 1 2010
End Date
October 1 2011
Last Update
January 2 2012
Active Locations (2)
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1
Preventive Medicine Center
Thanh Sơn, Phu Tho, Vietnam
2
Thai Binh Preventive Medicine Center
Thái Bình, Thai Binh, Vietnam