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

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ClinicalTrials.gov Identifier: NCT03680417
Recruitment Status : Completed
First Posted : September 21, 2018
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
PT Bio Farma

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

Condition or disease Intervention/treatment Phase
Safety Issues Immunogenicity Biological: Measles-Rubella (MR) Vaccine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Outcomes Assessor)
Masking Description: laboratory analyst are masked for the evaluation of antibody against measles and rubella. The immunogenicity is measured before and after vaccination.
Primary Purpose: Prevention
Official Title: Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
Actual Study Start Date : November 16, 2017
Actual Primary Completion Date : February 26, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Rubella

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.




Primary Outcome Measures :
  1. Number of Immediate systemic events [ Time Frame: 30 minutes ]
    Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination

  2. Percentage of immediate systemic events [ Time Frame: 30 minutes ]
    Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination


Secondary Outcome Measures :
  1. Local reaction [ Time Frame: 72 hours ]
    Number of subjects with at least one local reaction occurring within 72 h after vaccination.

  2. Systemic reaction [ Time Frame: 72 hours ]
    Number of subjects with at least one systemic event occurring within 72 h after vaccination.

  3. Delayed Local reaction [ Time Frame: 11 days ]
    Number of subjects with at least one local reaction occurring between day 4-14 after vaccination.

  4. Delayed systemic event [ Time Frame: 11 days ]
    Number of subjects with at least one systemic event occurring between day 4-14 after vaccination.

  5. Late Local reaction [ Time Frame: 14 days ]
    -Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.

  6. Late Safety (Systemic event) [ Time Frame: 14 days ]
    Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.

  7. Safety (serious adverse event) [ Time Frame: 28 days ]
    - Number of serious adverse event occuring from inclusion until 28 days after immunization

  8. Immunogenicity for Measles (subject with anti measles titer ≥ 8 (1/dil)) [ Time Frame: 28 days ]
    - Percentage of subjects with anti measles titer ≥ 8 (1/dil), 28 days after one dose of MR vaccine in Infants & Children.

  9. Immunogenicity for Measles (Geometric Mean Titer) [ Time Frame: 28 days ]
    - Geometric Mean Titer of measles antibody

  10. Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times) [ Time Frame: 28 days ]
    - Percentage of infants with increasing measles antibody titer ≥ 4 times

  11. Immunogenicity for Measles (seroconversion from seronegative to seropositive) [ Time Frame: 28 days ]
    - Percentage of infants with transition of seronegative to seropositive.

  12. Immunogenicity for Rubella (Subjects with anti rubella titer ≥11 IU/ml) [ Time Frame: 28 days ]
    - Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of MR vaccine in Infants & Children.

  13. Immunogenicity for Rubella (Geometric Mean Titer) [ Time Frame: 28 days ]
    - Geometric Mean Titer of Rubella antibody.

  14. Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times) [ Time Frame: 28 days ]
    - Percentage of infants with increasing rubella antibody titer ≥ 4 times

  15. Immunogenicity for Rubella (seroconversion from seronegative to seropositive) [ Time Frame: 28 days ]
    - Percentage of infants with transition of seronegative to seropositive.



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Ages Eligible for Study:   9 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680417


Locations
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Indonesia
Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.
Surabaya, East Java, Indonesia, 60131
Sponsors and Collaborators
PT Bio Farma
Investigators
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Principal Investigator: Dominicus Husada, Dr Child Health Dept. Dr. Soetomo Hospital/School of Medicine, Airlangga Univ.

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Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT03680417     History of Changes
Other Study ID Numbers: PMS-MR-0417
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PT Bio Farma:
Measles-Rubella
Vaccine
Safety
Immunogenicity
Reactogenicity
Protectivity
Additional relevant MeSH terms:
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Measles
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs