NCT02880865

Brief Summary

This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not adversely affect immunogenicity or safety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
628

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 13, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2017

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 18, 2020

Completed
Last Updated

October 14, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

August 17, 2016

Results QC Date

August 27, 2020

Last Update Submit

September 18, 2020

Conditions

Encephalitis, JapaneseMeaslesMumpsRubella

Keywords

vaccine

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination

    Measles immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for measles at 56 days post-vaccination. Seropositivity was defined by a concentration of ≥ 120 mIU/mL of anti-measles neutralizing antibody titer, as measured by the plaque reduction neutralization test (PRNT) (dilution converted to concentration using the 3rd International Standard Reference serum).

    56 days after MMR dose 1 vaccination (Day 56)

  • Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination

    Rubella immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for rubella at 56 days post-vaccination. Seropositivity was defined as antirubella immunoglobulin G (IgG) concentration of ≥ 10 IU/mL (corresponding to an optical density ratio ≥ 1.10) using a commercial IgG enzyme-linked immunosorbent assay (ELISA).

    56 days after MMR dose 1 vaccination (Day 56)

Secondary Outcomes (14)

  • Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination

    56 days after MMR dose 1 vaccination (Day 56)

  • Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination

    56 days after MMR dose 1 vaccination (Day 56)

  • GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination

    56 days after MMR dose 1 vaccination (Day 56)

  • Seroconversion Rate for Measles 56 Days Post-vaccination

    56 days after MMR dose 1 vaccination (Day 56)

  • Seroconversion Rate for Mumps 56 Days Post-vaccination

    56 days after MMR dose 1 vaccination (Day 56)

  • +9 more secondary outcomes

Study Arms (2)

Group 1 - MMR and CD-JEV

EXPERIMENTAL

Participants receiving one dose of CD-JEV vaccine and one dose of MMR vaccine concurrently at Day 0; Group 1 will also receive a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).

Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccineBiological: Measles, mumps, rubella vaccine

Group 2 - MMR then CD-JEV

EXPERIMENTAL

Participants receiving one dose of MMR vaccine at Day 0 and one dose of CD-JEV 56 days later. Group 2 will receive a second dose of MMR per the routine immunization schedule at Day 84 (12 months of age).

Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccineBiological: Measles, mumps, rubella vaccine

Interventions

Live attenuated SA 14-14-2 Japanese Encephalitis vaccineBIOLOGICAL

Single 0.5 mL dose of World Health Organization prequalified live, attenuated SA 14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products, Chengdu, China, administered by subcutaneous injection

Also known as: CD-JEV, CD.JEVAX®, RS.JEV®
Group 1 - MMR and CD-JEVGroup 2 - MMR then CD-JEV
Measles, mumps, rubella vaccineBIOLOGICAL

Single 0.5 mL dose of live, attenuated measles-mumps-rubella vaccine (Schwarz measles virus, RIT 4385 mumps strain, and Wistar RA 27/3 rubella virus) manufactured by GlaxoSmithKline, Inc., administered by subcutaneous injection.

Also known as: MMR, Priorix®
Group 1 - MMR and CD-JEVGroup 2 - MMR then CD-JEV

Eligibility Criteria

Age9 Months - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute for Tropical Medicine

Manila, Philippines

Location

MeSH Terms

Conditions

Encephalitis, JapaneseMeaslesMumpsRubella

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesMorbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae Infections

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesMeasles VaccineViral VaccinesMumps VaccineRubella Vaccine

Results Point of Contact

Title
Jorge Flores, MD
Organization
PATH
jeflores@path.org
(202) 822-0033

Study Officials

  • Maria Rosario Capeding, MD

    Research Institute for Tropical Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 26, 2016

Study Start

October 13, 2016

Primary Completion

May 19, 2017

Study Completion

July 11, 2017

Last Updated

October 14, 2020

Results First Posted

September 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

The study team agrees that the practice of offering study results to participants in human research is fundamental to the ethical principle of respect for persons. However, the sponsor prefers to report at the aggregate level to maintain participant confidentiality and ensure results are community-based. Thus, the sponsor plans to report results at the aggregate level. The sponsor will produce a poster of the results to be placed at each health center. A community meeting may also be held to communicate the results. Aggregate results will also be posted on www.clinicaltrials.gov.

Locations

PH(1)