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

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

Study Overview

• Status: Completed
• Conditions: Safety Issues; Immunogenicity
• Intervention / Treatment: Biological: Measles-Rubella (MR) Vaccine

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 Type: Interventional
• Enrollment (Actual): 590
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • East Java
    • Surabaya, East Java, Indonesia, 60131
      • Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Safety Study (Measles-Rubella 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.	Biological: Measles-Rubella (MR) Vaccine; Measles and Rubella Vaccine, live attenuated (Serum Institute of India) Form : Freeze dried Dose : 1 dose 0.5 ml contains not less than 1000 CCID50 of measles virus and 1000 CCID50 of rubella virus.
Active Comparator: Sub Study (Measles-Rubella 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.	Biological: Measles-Rubella (MR) Vaccine; Measles and Rubella Vaccine, live attenuated (Serum Institute of India) Form : Freeze dried Dose : 1 dose 0.5 ml contains not less than 1000 CCID50 of measles virus and 1000 CCID50 of rubella virus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Immediate systemic events	Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination	30 minutes
Percentage of immediate systemic events	Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination	30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Investigators: Principal Investigator: Dominicus Husada, Dr, Child Health Dept. Dr. Soetomo Hospital/School of Medicine, Airlangga Univ.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): February 26, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; Reactogenicity; Measles-Rubella; Protectivity
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Togaviridae Infections; Rubivirus Infections; Measles; Rubella
• Other Study ID Numbers: PMS-MR-0417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No