Clinical trial NCT03680417: Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
Official title: Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Safety Issues
Immunogenicity
Keywords: Measles-Rubella
Vaccine
Safety
Immunogenicity
Reactogenicity
Protectivity
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2018-09-21
Enrollment: 590
Sex: ALL
Minimum age (years): 9
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Safety Group: open labeled, prospective intervention study, only assess the safety outcome Sub Group: open labeled, prospective intervention study, evaluate safety and protectivity outcome
Primary purpose: PREVENTION

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

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Immediate systemic events
timeFrame: 30 minutes
measure: Percentage of immediate systemic events
timeFrame: 30 minutes
Secondary outcomes:
measure: Local reaction
timeFrame: 72 hours
measure: Systemic reaction
timeFrame: 72 hours
measure: Delayed Local reaction
timeFrame: 11 days
measure: Delayed systemic event
timeFrame: 11 days
measure: Late Local reaction
timeFrame: 14 days
measure: Late Safety (Systemic event)
timeFrame: 14 days
measure: Safety (serious adverse event)
timeFrame: 28 days
measure: Immunogenicity for Measles (subject with anti measles titer ≥ 8 (1/dil))
timeFrame: 28 days
measure: Immunogenicity for Measles (Geometric Mean Titer)
timeFrame: 28 days
measure: Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times)
timeFrame: 28 days
measure: Immunogenicity for Measles (seroconversion from seronegative to seropositive)
timeFrame: 28 days
measure: Immunogenicity for Rubella (Subjects with anti rubella titer ≥11 IU/ml)
timeFrame: 28 days
measure: Immunogenicity for Rubella (Geometric Mean Titer)
timeFrame: 28 days
measure: Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times)
timeFrame: 28 days
measure: Immunogenicity for Rubella (seroconversion from seronegative to seropositive)
timeFrame: 28 days
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.
state: East Java
Study officials:
affiliation: Child Health Dept. Dr. Soetomo Hospital/School of Medicine, Airlangga Univ.
name: Dominicus Husada, Dr
role: PRINCIPAL_INVESTIGATOR
References: