Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children

Phase 4

Completed

• Conditions: Safety Issues; Immunogenicity
• Interventions: Biological: Measles-Rubella (MR) Vaccine

• Registration Number: NCT03680417
• Lead Sponsor: PT Bio Farma

Brief Summary

to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants

Detailed Description

* to asses serious immediate systemic events,

* to assess local and systemic reaction after Measles-Rubella (MR) vaccine in infants and children,

* to evaluate protectivity and antibody response to measles and rubella after 1 dose of MR vaccine

Study Timeline

• Study Start: 2017-11-16
• Primary Completion: 2018-02-26
• Study Completion: 2018-08-01
• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 590

Inclusion Criteria

• Healthy infants (9-12 months) or children (18-47 months)
• Will receive MR routine immunization.
• Parents have been informed properly regarding the study and signed the informed consent form.
• Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria

• MR vaccine given simultaneously with other vaccination, except Pentabio (DTP/HB/Hib)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safety Study (Measles-Rubella vaccine)	Measles-Rubella (MR) Vaccine	open labeled, prospective intervention study, only assess the safety outcome. The Measles-Rubella vaccine is administered in infants age 9-12 months or 18 - 47 months. This study group only assessed for safety profile of the Measles-Rubella vaccine.
Sub Study (Measles-Rubella vaccine)	Measles-Rubella (MR) Vaccine	open labeled, prospective intervention study, assess the safety and immunogenicity outcome. The Measles-Rubella vaccine is administered in infants age 9-12 months or 18 - 47 months. For Sub study, pre- and post immunization sera will be obtained from 200 infants and/or children. Safety assessment also evaluated for 28 days after immunization.

Primary Outcome Measures

Name	Time	Method
Number of Immediate systemic events	30 minutes	Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Percentage of immediate systemic events	30 minutes	Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination

Secondary Outcome Measures

Name	Time	Method
Immunogenicity for Rubella (seroconversion from seronegative to seropositive)	28 days	- Percentage of infants with transition of seronegative to seropositive.
Late Safety (Systemic event)	14 days	Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
Immunogenicity for Measles (seroconversion from seronegative to seropositive)	28 days	- Percentage of infants with transition of seronegative to seropositive.
Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times)	28 days	- Percentage of infants with increasing rubella antibody titer ≥ 4 times
Systemic reaction	72 hours	Number of subjects with at least one systemic event occurring within 72 h after vaccination.
Delayed Local reaction	11 days	Number of subjects with at least one local reaction occurring between day 4-14 after vaccination.
Immunogenicity for Measles (Geometric Mean Titer)	28 days	- Geometric Mean Titer of measles antibody
Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times)	28 days	- Percentage of infants with increasing measles antibody titer ≥ 4 times
Safety (serious adverse event)	28 days	- Number of serious adverse event occuring from inclusion until 28 days after immunization
Immunogenicity for Rubella (Subjects with anti rubella titer ≥11 IU/ml)	28 days	- Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of MR vaccine in Infants \& Children.
Delayed systemic event	11 days	Number of subjects with at least one systemic event occurring between day 4-14 after vaccination.
Late Local reaction	14 days	-Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
Immunogenicity for Measles (subject with anti measles titer ≥ 8 (1/dil))	28 days	- Percentage of subjects with anti measles titer ≥ 8 (1/dil), 28 days after one dose of MR vaccine in Infants \& Children.
Local reaction	72 hours	Number of subjects with at least one local reaction occurring within 72 h after vaccination.
Immunogenicity for Rubella (Geometric Mean Titer)	28 days	- Geometric Mean Titer of Rubella antibody.

Trial Locations

Locations (1)

Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.; 🇮🇩 Surabaya, East Java, Indonesia