Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)

Measles Clinical Trial

Official title:

Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183114
• Other study ID #: MR-BF 0319
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 3, 2019
• Est. completion date: November 11, 2019

Study information

• Verified date: December 2019
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: November 11, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Rubella Infection
• Measles
• Rubella

Intervention

Biological:
• Measles-Rubella vaccine Bio Farma
MR vaccine produced by Bio Frama with 3 consecutive batches
• MR Vaccine SII
MR Vaccine produced by SII (Already registered in Indonesia)

Locations

Country	Name	City	State
Indonesia	Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.	Surabaya	East Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months
Primary	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	4 months
Secondary	Immunogenicity of MR Vaccine in infants GMT	• Serological response to MR vaccine in infants: GMT	up to 4 months
Secondary	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.	up to 4 months
Secondary	Immunogenicity of MR Vaccine (seroconversion)	• Serological response to MR vaccine in infants: percentage of infants with transition of seronegative to seropositive.	up to 4 months
Secondary	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.	up to 4 months
Secondary	Comparison between each batch number of Bio Farma's MR vaccine.	• Serological response between each batch number of Bio Farma's MR vaccine.	up to 4 months
Secondary	Safety (immediate reactions)	• Immediate reactions within the first 30 minutes after vaccination	up to 30 minutes after vaccination
Secondary	Safety (72 hours)	• Local reactions and systemic events occurring within 72 h after vaccination.	up to 72 hours after vaccination
Secondary	Safety (14 days)	• Local reactions and systemic events occurring within 14 days after vaccination	up to 14 days after vaccination
Secondary	Safety (15 days to 28 days)	• Local reactions and systemic events occurring between 15 days to 28 days following injection.	up to 14 days
Secondary	Safety (Serious adverse event)	• Any serious adverse event occurring from inclusion until 28 days after immunization	up to 1 months/28 days
Secondary	Safety comparison between MR vaccine and control	• Description of adverse events between MR vaccine and control.	up to 1 months/28 days
Secondary	Safety comparison between each batch of MR vaccine	• Description of adverse events between each batch number of MR vaccine	up to 1 months/28 days