Status:
COMPLETED
Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old
Lead Sponsor:
Bharat Biotech International Limited
Collaborating Sponsors:
Ministry of Science and Technology, India
Centers for Disease Control and Prevention
Conditions:
Diarrhea
Eligibility:
All Genders
8-20 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy non-malnourished infants aged...
Detailed Description
Infants will be identified through a community survey in urban neighborhoods in the city of Delhi, India and screened at 6 weeks of age if parental consent is available. They will be given the first d...
Eligibility Criteria
Inclusion
- Access to telephone at home or in the immediate neighborhood.
- Healthy male and female non-malnourished (weight for length not ≤ -3 SD of WHO child growth standards) infants aged 6 weeks (till 6 weeks + 2 days).
- Parent's permission to participate in the study is available.
- No plans to travel over the next 4 months
Exclusion
- Gestational age \<37 weeks.
- Any major physical congenital malformation.
- Living in a household or has contact with an individual who is immunosuppressed.
- Hospitalized once or more for the following illnesses since birth: heart disease, pneumonia, sepsis, meningitis, unconsciousness.
- Is required to take daily medications other than vitamins or herbal "tonics".
- Evidence of cardiovascular disease as indicated by any of the following:
- Central cyanosis
- Cyanotic or apnoeic spells
- Features of congestive heart failure
- Significant heart murmur detected on physical examination
- Evidence of gastrointestinal disease indicated by following:
- Diarrhea in the previous 7 days
- Blood in the stools any time since birth
- Evidence of neurological disease, as indicated by:
- History of seizures any time since birth
- History of unconsciousness
- Focal deficit on physical examination
- Evidence of liver or other reticuloendothelial disease, as indicated by any of the following:
- Positive serology for hepatitis B surface antigen
- Positive serology for hepatitis C antibody
- SGOT or SGPT more than 1.25 times upper limit of normal (Upper limit normal SGOT 80 IU/L, SGPT 40 IU/L)
- Alkaline phosphatase more than 1.25 times upper limit of normal (Upper limit of normal -470 IU/L)
- Hepatomegaly (liver palpable 3 cm below costal margin), splenomegaly (palpable spleen), jaundice, or lymphadenopathy on physical examination
- Serum bilirubin 1.25 times the upper limit of normal for age (Upper limit of normal 1.0 mg/dL).
- Evidence of hematologic, rheumatologic, or immunologic disease, as indicated by any of the following:
- Total leukocyte count \<3500 or \>15,000/mm3
- Hemoglobin \<9 g/dL or \>17g/dL
- Platelet count \<100,000/mm3
- Any episode of sepsis, pneumonia or meningitis requiring hospitalization since birth.
- Evidence of renal disease as indicated by any of the following:
- Creatinine \>0.5 mg/dL
- Hematuria (≥5 RBC/hpf)
- Proteinuria (≥1+ per day)
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00439660
Start Date
December 1 2006
End Date
November 1 2008
Last Update
February 23 2021
Active Locations (1)
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1
Society for Applied Studies (SAS)
New Delhi, India, 110 017