Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants … (NCT00439660) | Clinical Trial Compass
CompletedPhase 1/2
Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old
India540 participantsStarted 2006-12
Plain-language 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 8-20 weeks at three different dosage levels i.e.10\^4.0, 10\^5.0 and 10\^6.0 FFU and for three administrations of each of these dosages given to infants at 4-week intervals. 180 infants (90 vaccinees/90 placebo) will be enrolled for each of the three dosage levels. The progression from the lower to the next higher dosage will be based on approval by the Data Safety Monitoring Board (DSMB) to be constituted by the Department of Biotechnology, New Delhi.
Who can participate
Age range8 Weeks – 20 Weeks
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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".