Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02880865
• Date of registration: 17/08/2016
• Prospective Registration: Yes
• Primary sponsor: PATH
• Public title: Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine
• Scientific title: Immunogenicity and Safety of Concurrent Administration of Live, Attenuated SA 14-14-2 Japanese Encephalitis Vaccine and Measles-Mumps-Rubella Vaccine in Infants 9-12 Months of Age in the Philippines
• Date of first enrolment: October 13, 2016
• Target sample size: 628
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02880865
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Philippines

Contacts

• Name: Maria Rosario Capeding, MD
• Affiliation: Research Institute for Tropical Medicine,

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 9 months to < 10 months at the time of enrollment.

- Residence in the study area.

- At least one parent or guardian willing to provide written informed consent.

- Generally healthy and free of obvious health problems as established by medical
history, physical examination, and clinical judgment.

- A parent or guardian is willing to attend all planned study visits and allow home
visits and phone contacts, as required by the protocol.

Exclusion Criteria:

- Previous receipt of any measles-mumps-rubella containing vaccine.

- Previous receipt of any Japanese encephalitis vaccine.

- History of measles, mumps, rubella, or Japanese encephalitis infection.

- Administration of any other vaccine within 28 days prior to administration of a study
vaccine or planned vaccination of any vaccine other than catch-up doses of routine EPI
vaccines or oral polio vaccine during the 28 days after study vaccination.

- History of allergic disease or known hypersensitivity to any component of the study
vaccines and/or following administration of vaccines included in the local program of
immunization.

- Use of any investigational or non-registered drug within 90 days prior to the
administration of study vaccines or planned administration during the study period.

- Administration of immunoglobulins and/or any blood products within 90 days prior to
the administration of study vaccines or planned administration during the study
period.

- Chronic administration (defined as > 7 days) of immunosuppressing or other
immune-modifying agents within 14 days before or after vaccination (including systemic
corticosteroids equivalent to prednisone = 0.5 mg/kg/day; topical and inhaled steroids
are allowed).

- Primary or acquired immunodeficiency, including human immunodeficiency virus (HIV)
infection, or a family history of congenital or hereditary immunodeficiency as
reported by parent.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal
functional abnormality, as determined by medical history or physical examination,
which might interfere with the study objectives.

- Severely malnourished infants as measured by World Health Organization
weight-for-height tables (Z-score < -3).

- Any condition or criterion that, in the opinion of the study physician, might
compromise the well-being of the participant, compliance with study procedures, or
interpretation of the outcomes of the study.

- Acute illness at the time of enrollment defined as the presence of a moderate or
severe illness with fever (axillary temperature = 38.0°C) or without fever (severity
determined at the discretion of the study physician). Acute illness is a temporary
exclusion. Vaccination should be postponed at least 7 days after recovery. A visit for
reassessment may be scheduled 7 days or more after temporary exclusion illness is
resolved. Eligibility for study participation must be reassessed again at the next
visit.



Age minimum: 9 Months
Age maximum: 9 Months
Gender: All

Health Condition(s) or Problem(s) studied

Encephalitis, Japanese

Measles

Mumps

Rubella

Intervention(s)

Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine

Biological: Measles, mumps, rubella vaccine

Primary Outcome(s)

Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination [Time Frame: 56 days after MMR dose 1 vaccination (Day 56)]

Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination [Time Frame: 56 days after MMR dose 1 vaccination (Day 56)]

Secondary Outcome(s)

Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination [Time Frame: 30 minutes following each study vaccination]

Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity [Time Frame: 30 minutes through 14 days following each vaccination]

Seroconversion Rate for Mumps 56 Days Post-vaccination [Time Frame: 56 days after MMR dose 1 vaccination (Day 56)]

Seroconversion Rate for Rubella 56 Days Post-vaccination [Time Frame: 56 days after MMR dose 1 vaccination (Day 56)]

Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination [Time Frame: 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2)]

Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination [Time Frame: 56 days after MMR dose 1 vaccination (Day 56)]

Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination [Time Frame: 56 days after MMR dose 1 vaccination (Day 56)]

GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination [Time Frame: 56 days after MMR dose 1 vaccination (Day 56)]

Number of Participants With Serious Adverse Events Throughout the Study [Time Frame: Up to 112 days]

Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity [Time Frame: 30 minutes through 14 days following each vaccination]

Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination [Time Frame: 28 days following each vaccination]

Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination [Time Frame: 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2)]

Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination [Time Frame: 30 minutes through 14 days following each vaccination]

Seroconversion Rate for Measles 56 Days Post-vaccination [Time Frame: 56 days after MMR dose 1 vaccination (Day 56)]

Secondary ID(s)

JEV06

PHRR160822-001339

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Research Institute for Tropical Medicine,

DF/Net Research, Inc.

Syneos Health

Results

• Results available: Yes
• Date Posted: 18/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02880865