Thus study is a clinical trial for Measles and Rubella vaccine that will be used inIndonesian National Program of Immunization. The study design will be randomized, observer blind, prospective intervention study.
The objectives of the study are: * To assess the protectivity rate of Bio Farma's Measles/Rubella (MR) vaccine in infants * To describe antibody response to Measles and Rubella after 1 dose of Bio Farma's MR vaccine as a primary dose in infants * To assess the safety of Bio Farma's Measles/Rubella (MR) vaccine in infants * To evaluate immunogenicity and safety one dose of Bio Farma's MR vaccine compare to registered MR vaccine. * To evaluate immunogenicity and safety in three consecutive batches of Bio Farma's MR vaccine in infants .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
540
MR vaccine produced by Bio Frama with 3 consecutive batches
MR Vaccine produced by SII (Already registered in Indonesia)
Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.
Surabaya, East Java, Indonesia
Protectivity of Measles
Percentage of subjects with anti measles titer ≥ 8(1/dil), 28 days after one dose of Bio Farma's MR vaccine in Infants
Time frame: 4 months
Protectivity of Rubella
Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of Bio Farma's MR vaccine in Infants
Time frame: 4 months
Immunogenicity of MR Vaccine in infants GMT
• Serological response to MR vaccine in infants: GMT
Time frame: up to 4 months
Immunogenicity of MR Vaccine (4 Folds increase of antibody titer)
• Serological response to MR vaccine in infants: percentage of infants with increasing antibody titer \> 4 times.
Time frame: up to 4 months
Immunogenicity of MR Vaccine (seroconversion)
• Serological response to MR vaccine in infants: percentage of infants with transition of seronegative to seropositive.
Time frame: up to 4 months
Comparison Between MR (Bio Farma) Vaccine and Registered MR Vaccine
• Comparability of serological response to Measles and Rubella component, pre and post vaccination with Bio Farma's MR vaccine compared to registered MR vaccine in infants.
Time frame: up to 4 months
Comparison between each batch number of Bio Farma's MR vaccine.
• Serological response between each batch number of Bio Farma's MR vaccine.
Time frame: up to 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Safety (immediate reactions)
• Immediate reactions within the first 30 minutes after vaccination
Time frame: up to 30 minutes after vaccination
Safety (72 hours)
• Local reactions and systemic events occurring within 72 h after vaccination.
Time frame: up to 72 hours after vaccination
Safety (14 days)
• Local reactions and systemic events occurring within 14 days after vaccination
Time frame: up to 14 days after vaccination
Safety (15 days to 28 days)
• Local reactions and systemic events occurring between 15 days to 28 days following injection.
Time frame: up to 14 days
Safety (Serious adverse event)
• Any serious adverse event occurring from inclusion until 28 days after immunization
Time frame: up to 1 months/28 days
Safety comparison between MR vaccine and control
• Description of adverse events between MR vaccine and control.
Time frame: up to 1 months/28 days
Safety comparison between each batch of MR vaccine
• Description of adverse events between each batch number of MR vaccine
Time frame: up to 1 months/28 days