Immunogenicity Clinical Trial
Open-label, single-arm trial, Primary Objectives included:
1. To assess the immunogenicity of TrivivacTM administered in healthy infants aged between
9-14 months.
2. To assess the safety (reactogenicity) of TrivivacTM administered in healthy infants
aged between 9-14 months.
The study will be done on healthy infants, 9-14 months of age. After enrolment, the infants
will be given one dose of primary vaccination MMR (TrivivacTM),SEVAPHARMA BiogenetechLtd.
study vaccines will be administered subcutaneously into the anterolateral aspect of right
thigh.outer aspect of the upper arm. Subjects will be followed at approximately 6 weeks
after primary vaccination to evaluate response to primary immunization of this vaccine.
Blood sample will be collected from subjects at visit 1 (prior to immunization) and visit 2
(6 weeksone month after completion of this first dose of immunization). The serum samples
will be analysed for Anti-measles, Anti-mumps and Anti-rubella antibodies. Proportion of
subjects achieving seroprotection and geometric mean titers of antibody against measles,
mumps, rubella at 6 weeks after one dose vaccination of MMR vaccine at aged 9-14 months will
be evaluated. Adverse reactions will be observed on each vaccination day (up to 30 minutes)
and for 4 days (Day 0-3) after each dose. Adverse reactions will also be monitored for 30
days following each vaccination. Serious adverse events will be monitored for the entire
study duration.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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