Clinical trial NCT04183114: Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
Official title: Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Congenital Rubella Infection
Measles
Keywords: Vaccine
Measles
Rubella
Bio Farma
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 540
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: healthy infants aged 9 - 12 months
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

1. Healthy Infants, 9-12 months
2. Parents have been informed properly regarding the study and signed the informed consent form
3. Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \> 37.5 Centigrade).
3. Known history of allergy to neomycin, kanamycin or erythromycin or any component of the vaccines.
4. History of immunodeficiency disorder or disorders like HIV infection, leukemia, lymphoma, or generalized malignancy that can alter immune response.
5. Subjects who have previously received any measles and/or rubella containing vaccines.
6. Subjects who had a clinical history of measles/rubella infection.
7. Subjects who has received in the previous 3 months a treatment likely to alter the immune response (intravenous immunoglobulin, blood-derived products or long term corticosteroidtherapy (\> 2 weeks).
8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
9. Subject already immunized with any vaccine within 4 weeks prior vaccination.

Primary outcomes:
measure: Protectivity of Measles
timeFrame: 4 months
measure: Protectivity of Rubella
timeFrame: 4 months
Secondary outcomes:
measure: Immunogenicity of MR Vaccine in infants GMT
timeFrame: up to 4 months
measure: Immunogenicity of MR Vaccine (4 Folds increase of antibody titer)
timeFrame: up to 4 months
measure: Immunogenicity of MR Vaccine (seroconversion)
timeFrame: up to 4 months
measure: Comparison Between MR (Bio Farma) Vaccine and Registered MR Vaccine
timeFrame: up to 4 months
measure: Comparison between each batch number of Bio Farma's MR vaccine.
timeFrame: up to 4 months
measure: Safety (immediate reactions)
timeFrame: up to 30 minutes after vaccination
measure: Safety (72 hours)
timeFrame: up to 72 hours after vaccination
measure: Safety (14 days)
timeFrame: up to 14 days after vaccination
measure: Safety (15 days to 28 days)
timeFrame: up to 14 days
measure: Safety (Serious adverse event)
timeFrame: up to 1 months/28 days
measure: Safety comparison between MR vaccine and control
timeFrame: up to 1 months/28 days
measure: Safety comparison between each batch of MR vaccine
timeFrame: up to 1 months/28 days
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.
state: East Java
Study officials:
References: