Encephalitis, JapanesePhase 4NCT02880865
Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine
A Phase 4 study testing Live attenuated SA 14-14-2 Japanese Encephalitis vaccine and Measles, mumps, rubella vaccine in people with Encephalitis, Japanese and Measles, run by PATH at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Encephalitis, Japanese, Measles, Mumps
- What is being tested?
- Live attenuated SA 14-14-2 Japanese Encephalitis vaccine and Measles, mumps, rubella vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 1 sitePhilippines
- Study dates
- 13 Oct 2016to 11 Jul 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
When incorporating a new vaccine in the Expanded Programme on Immunization (EPI), it is important to provide evidence that it can be introduced concurrently with other routine pediatric vaccines without significantly impairing the immune response to any vaccine while maximizing coverage and minimizing cost. This non-inferiority study aims to compare CD-JEV and MMR responses in a population of children in a country where MMR introduction is ongoing or planned. This information will help the ministries of health evaluate the addition of CD-JEV into routine EPI.
- Conditions
- Encephalitis, Japanese, Measles, Mumps, Rubella
- Being tested
- Live attenuated SA 14-14-2 Japanese Encephalitis vaccine, Measles, mumps, rubella vaccine
- Keywords
- vaccine
- Medical subject headings
- Encephalitis, Japanese, Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live attenuated SA 14-14-2 Japanese Encephalitis vaccineBiological
Also called CD-JEV, CD.JEVAX®, RS.JEV®
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
Measles, mumps, rubella vaccineBiological
Also called MMR, Priorix®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine; Biological: 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). Receives: Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine; Biological: Measles, mumps, rubella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 56 days after MMR dose 1 vaccination (Day 56)
Secondary outcomes (14)
Percentage of Participants With Mumps Seropositivity 56 Days Post-vaccination
Mumps immunogenicity was assessed by the percentage of participants with demonstrated seropositivity for mumps at 56 days post-vaccination. Seropositivity was defined as an optical density ratio ≥ 1.10 using a commercial ELISA.
Measured: 56 days after MMR dose 1 vaccination (Day 56)
Geometric Mean Concentration (GMC) for Anti-measles Neutralizing Antibody Concentration at 56 Days Post-vaccination
Anti-measles neutralizing antibody concentration was measured by the plaque reduction neutralization test (PRNT).
Measured: 56 days after MMR dose 1 vaccination (Day 56)
GMC for Anti-rubella IgG Antibody Concentration at 56 Days Post-vaccination
Anti-rubella immunoglobulin G (IgG) concentration was measured using a commercial IgG enzyme-linked immunosorbent assay (ELISA).
Measured: 56 days after MMR dose 1 vaccination (Day 56)
Seroconversion Rate for Measles 56 Days Post-vaccination
The seroconversion rate for measles at 56 days post-vaccination was defined as the percentage of participants with a change in serostatus from negative to positive 56 days after vaccination or a four-fold rise in concentration 56 days after vaccination if seropositive for measles at baseline. 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).
Measured: 56 days after MMR dose 1 vaccination (Day 56)
Seroconversion Rate for Mumps 56 Days Post-vaccination
The seroconversion rate for mumps at 56 days post-vaccination was defined as the percentage of participants with a change in serostatus from negative to positive 56 days after vaccination. Seropositivity was defined as an optical density ratio ≥ 1.10, measured using a commercial ELISA. Participants with equivocal serostatus at baseline are counted as non-responders.
Measured: 56 days after MMR dose 1 vaccination (Day 56)
Seroconversion Rate for Rubella 56 Days Post-vaccination
The seroconversion rate for rubella at 56 days post-vaccination was defined as the percentage of participants with a change in serostatus from negative to positive 56 days after vaccination or a four-fold rise in concentration 56 days after vaccination if seropositive for rubella at baseline. Seropositivity is defined as a post-vaccination concentration of ≥ 10 IU/mL measured using a commercial ELISA.
Measured: 56 days after MMR dose 1 vaccination (Day 56)
Percentage of Participants With Japanese Encephalitis Seropositivity 28 Days Post-vaccination
Japanese encephalitis (JE) immunogenicity was assessed by the percentage of participants with demonstrated seropositivity 28 days after CD-JEV vaccination. Seropositivity was defined as an anti-JE serum neutralizing antibody titer of ≥ 1:10, as measured by JE PRNT-50.
Measured: 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2)
Geometric Mean Titer (GMT) for Serum Neutralizing Antibody Titer to JE Virus at 28 Days Post-vaccination
Anti-JE serum neutralizing antibody titer was measured using JE PRNT-50.
Measured: 28 days after CD-JEV vaccination (Day 28 for Group 1 and Day 84 for Group 2)
Number of Participants With Immediate Reactions Within 30 Minutes of Each Vaccination
Participants were observed for 30 minutes after each vaccination for immediate reactions. Immediate reactions included both local (injection site) and systemic reactions. MMR vaccine was injected on left upper thigh and CD-JEV was injected on right upper thigh.
Serious reactions were those meeting one of the following conditions:
- Death.
- Life threatening
- Required inpatient hospitalization or prolongation of existing hospitalization.
- Resulted in a persistent or significant disability or incapacity.
- Important medical events that, based upon appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: 30 minutes following each study vaccination
Number of Participants With Solicited Local and Systemic Reactions Within 14 Days of Each Vaccination
Reactogenicity post-vaccination was assessed from 30 minutes through 14 days following vaccination.
Parents used a structured reactogenicity diary card to record the following solicited (pre-listed) local and system reactions.
Local reactions (at injection site):
- Ecchymosis (bruising)
- Erythema (redness)
- Edema (swelling)
- Induration (hardness)
- Pain/tenderness
Systemic reactions:
- Fever
- Rash
- Cough
- Runny nose
- Change in eating habits
- Diarrhea
- Sleepiness
- Irritability
- Unusual crying
- Vomiting
Measured: 30 minutes through 14 days following each vaccination
Number of Participants With Solicited Local Reactions Within 14 Days of Each Vaccination by Maximum Severity
Parents recorded local reactions on a diary card.
Local ecchymosis, erythema, edema, and induration were graded as follows:
Grade 1: ≤2.5 cm in diameter.
Grade 2: >2.5 cm in diameter with 50% of surface area of extremity segment involved.
Grade 3: ≥50% surface area of extremity segment involved OR ulceration OR secondary infection OR phlebitis OR sterile abscess OR drainage.
Grade 4: potentially life-threatening (e.g., abscess, exfoliative dermatitis, necrosis involving dermis or deeper tissue).
Injection site pain/tenderness (pain without touching or tenderness when the area is touched) were graded as follows:
Grade 1: pain/tenderness causing no or minimal limitation of use of limb. Grade 2: pain/tenderness causing greater than minimal limitation of use of limb.
Grade 3: pain/tenderness causing inability to perform usual social and functional activities.
Grade 4: pain/tenderness causing inability to perform basic self-care OR hospitalization indicated.
Measured: 30 minutes through 14 days following each vaccination
Number of Participants With Systemic Reactions Within 14 Days of Each Vaccination by Maximum Severity
Parents recorded systemic reactions on a diary card.
Fever was recorded and graded as follows (axillary temperature):
Grade 1: 37.5°C to 37.9°C
Grade 2: 38.0°C to 38.4°C
Grade 3: 38.5°C to 40.0°C
Grade 4: >40.0°C
Rash, cough, runny nose, change in eating habits, diarrhea, sleepiness, irritability, unusual crying, vomiting, and any other unsolicited reaction occurring from 30 minutes through 14 days post vaccination were graded as follows:
Grade 1: symptoms causing no or minimal interference with usual social and functional activities.
Grade 2: symptoms causing greater than minimal interference with usual social and functional activities.
Grade 3: symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated.
Grade 4: symptoms causing inability to perform basic self-care functions OR medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.
Measured: 30 minutes through 14 days following each vaccination
Number of Participants With Unsolicited Adverse Events Within 28 Days of Each Vaccination
Each adverse event (AE) was assessed for relationship to vaccine by the study clinician according to the following:
Definitely Related: An adverse event or unanticipated problem clearly related to the research procedures.
Possibly Related: There is a reasonable possibility that the adverse event or unanticipated problem, incident, experience, or outcome may have been caused by the procedures involved in the research.
Not Related: Any adverse event or unanticipated problem clearly not related to study procedures.
Related adverse events includes events that were assessed as definitely or possibly related.
Measured: 28 days following each vaccination
Number of Participants With Serious Adverse Events Throughout the Study
A serious adverse event (SAE) was defined as an AE that met one of the following:
- Death
- Life threatening
- Required inpatient hospitalization or prolongation of existing hospitalization
- Resulted in persistent or significant disability or incapacity
- Important medical events that, based upon appropriate medical judgment, jeopardized the participant and required medical or surgical intervention to prevent an outcomes listed above
AEs were assessed for relationship to vaccine by the study clinician according to the following:
Definitely Related: An AE or unanticipated problem clearly related to the research procedures.
Possibly Related: There is a reasonable possibility that the AE or unanticipated problem, incident, experience, or outcome may have been caused by the procedures involved in the research.
Not Related: Any AE or unanticipated problem clearly not related to study procedures.
Related SAEs includes events that were assessed as definitely or possibly related.
Measured: Up to 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start13 Oct 2016
- Primary completion19 May 2017
- Study completion11 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Encephalitis, JapaneseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute for Tropical Medicine, Syneos Health, DFNet Research Inc.
- Responsible party
- Sponsor
- Investigators
- Maria Rosario Capeding, MD, Principal investigator, Research Institute for Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880865
- Sponsor's protocol ID
- JEV06
- Other IDs
- PHRR160822-001339
- Status last verified
- Mar 2020
- First submitted
- 17 Aug 2016
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02880865
- Acronym / sponsor ID
- JEV06
- Conditions
- Encephalitis, Japanese, Measles, Mumps, Rubella
- Keywords
- vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Research Institute for Tropical Medicine, Syneos Health, DFNet Research Inc.
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Posted 18 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
When incorporating a new vaccine in the Expanded Programme on Immunization (EPI), it is important to provide evidence that it can be introduced concurrently with other routine pediatric vaccines without significantly impairing the immune response to any vaccine while maximizing coverage and minimizing cost. This non-inferiority study aims to compare CD-JEV and MMR responses in a population of children in a country where MMR introduction is ongoing or planned. This information will help the ministries of health evaluate the addition of CD-JEV into routine EPI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - MMR and CD-JEV | Experimental | Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine, Biological: Measles, mumps, rubella vaccineParticipants 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). |
| Group 2 - MMR then CD-JEV | Experimental | Biological: Live attenuated SA 14-14-2 Japanese Encephalitis vaccine, Biological: Measles, mumps, rubella vaccineParticipants 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). |
Who may qualify
- Ages
- 9 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live attenuated SA 14-14-2 Japanese Encephalitis vaccineAlso: CD-JEV, CD.JEVAX®, RS.JEV®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 | Biological | Group 1 - MMR and CD-JEV, Group 2 - MMR then CD-JEV |
| Measles, mumps, rubella vaccineAlso: MMR, Priorix®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. | Biological | Group 1 - MMR and CD-JEV, Group 2 - MMR then CD-JEV |
Primary outcome
Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination
Time frame: 56 days after MMR dose 1 vaccination (Day 56)
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).
Percentage of Participants With Rubella Seropositivity 56 Days Post-vaccination
Time frame: 56 days after MMR dose 1 vaccination (Day 56)
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).
14 secondary outcomes
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)
Seroconversion Rate for Measles 56 Days Post-vaccination
Time frame: 56 days after MMR dose 1 vaccination (Day 56)
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)
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 Immediate Reactions Within 30 Minutes of Each Vaccination
Time frame: 30 minutes following each study vaccination
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
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
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
Number of Participants With Serious Adverse Events Throughout the Study
Time frame: Up to 112 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Rosario Capeding, MD principal investigator
Research Institute for Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Live attenuated SA 14-14-2 Japanese Encephalitis vaccine and Measles, mumps, rubella vaccine in people with Encephalitis, Japanese and Measles, run by PATH at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Measles Seropositivity 56 Days Post-vaccination (time frame: 56 days after MMR dose 1 vaccination (Day 56)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.