Immunogenicity and Reactogenicity of a Trivalent MMR (Trivivac) in Healthy Infants
Open-label, single-arm trial, Primary Objectives included:
- To assess the immunogenicity of TrivivacTM administered in healthy infants aged between 9-14 months.
- 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.
Biological: Trivivac vaccine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
- Immunogenicity as measured by the proportion of subjects achieving seroprotection against measles, mumps and rubella [ Time Frame: 6 weeks after vaccination ] [ Designated as safety issue: No ]
Immunogenicity of Trivivac vaccine is determined by proportion of subjects achieving seroprotection against measles, mumps and rubella at 6 weeks (42 days) after application of first dose of vaccine MMR. The amount of specific antibodies against measles, mumps and rubella will be evaluated in sera collected approximately 42+ 7 days following primary vaccination with the Trivivac vaccine.
Seroconversion and GMT against measles, mumps, and rubella will be defined by Enzyme immunoassay for the qualitative detection and quantitative determination of specific IgG antibodies against measles, mumps and rubella virus in human serum (Enzygnost® Anti-Measles Virus/IgG, Anti-Mumps Virus/IgG and Anti-Rubella Virus/IgG; SIEMENS).
- Reactogenicity as measured by the prevalence of local and systemic adverese reaction [ Time Frame: Day0 to day3 after vaccination ] [ Designated as safety issue: Yes ]Occurrence, intensity and relationship to vaccination of early expected and unexpected local and systemic adverse drug reactions reported during the 4-day (Day 0-3) follow-up period after vaccination.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Children who receive Trivivac vaccine
Biological: Trivivac vaccine
Trivalent MMR vaccine
|Contact: Warunee P Vandepitte, MD, PhDfirstname.lastname@example.org|
|Queen Sirikit National Institute of Child Health||Recruiting|
|Bangkok, Thailand, 10400|
|Contact: Warunee Punpanich Vandepitte, MD, PhD 66855158299 email@example.com|
|Principal Investigator: Warunee P Vandepitte, MD, PhD|