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

PT Bio Farma

Status and phase: Completed; Phase 4

Conditions: Safety Issues; Immunogenicity

Treatments: Biological: Measles-Rubella (MR) Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03680417

PMS-MR-0417

Details and patient eligibility

About

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

Full 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

Enrollment: 590 patients

Sex: All

Ages: 9 to 47 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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590 participants in 2 patient groups

Safety Study (Measles-Rubella vaccine)

Active Comparator group

Description:

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.

Treatment:

Biological: Measles-Rubella (MR) Vaccine

Sub Study (Measles-Rubella vaccine)

Active Comparator group

Description:

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.

Treatment:

Biological: Measles-Rubella (MR) Vaccine