NCT03680417

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

September 18, 2018

Last Update Submit

September 10, 2019

Conditions

Safety IssuesImmunogenicity

Keywords

Measles-RubellaVaccineSafetyImmunogenicityReactogenicityProtectivity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (15)

  • Local reaction

    72 hours

  • Systemic reaction

    72 hours

  • Delayed Local reaction

    11 days

  • Delayed systemic event

    11 days

  • Late Local reaction

    14 days

  • +10 more secondary outcomes

Study Arms (2)

Safety Study (Measles-Rubella vaccine)

ACTIVE COMPARATOR

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

Sub Study (Measles-Rubella vaccine)

ACTIVE COMPARATOR

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

Interventions

Measles-Rubella (MR) VaccineBIOLOGICAL

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.

Safety Study (Measles-Rubella vaccine)Sub Study (Measles-Rubella vaccine)

Eligibility Criteria

Age9 Months - 47 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.

Surabaya, East Java, 60131, Indonesia

Location

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Dominicus Husada, Dr

    Child Health Dept. Dr. Soetomo Hospital/School of Medicine, Airlangga Univ.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
laboratory analyst are masked for the evaluation of antibody against measles and rubella. The immunogenicity is measured before and after vaccination.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Safety Group: open labeled, prospective intervention study, only assess the safety outcome Sub Group: open labeled, prospective intervention study, evaluate safety and protectivity outcome
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 21, 2018

Study Start

November 16, 2017

Primary Completion

February 26, 2018

Study Completion

August 1, 2018

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)