NCT01763268

Immunogenicity and Reactogenicity of a Trivalent MMR (Trivivac) in Healthy Infants

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Queen Sirikit National Institute of Child Health · Other Government
• Sex: All
• Age: 9 Months – 14 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Immunogenicity
• Reactogenicity

Interventions

Type	Name	Description
BIOLOGICAL	Trivivac vaccine	Trivalent MMR vaccine

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-01-01
• Completion: 2015-08-01
• First posted: 2013-01-08
• Last updated: 2013-01-08

Locations

1 site across 1 country: Thailand