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OpenTrials
Completed

NCT Number: NCT03680417

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

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Key information

Conditions

Safety Issues Immunogenicity

Age range

9 month–47 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Surabaya, East Java, 60131, Indonesia

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Measles-Rubella (MR) Vaccine

Biological

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2018
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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