Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Assessment of the Non-Inferiority of the Concurrent Administration of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Measles Vaccine Given Alone
1 other identifier
interventional
600
1 country
1
Brief Summary
This study will determine whether it is safe and effective to administer Japanese encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If it is found to be safe, it will pave the way for use in routine vaccination programs. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time are protected against these diseases at the same level as those who receive the vaccines at different intervals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2005
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2005
CompletedFirst Posted
Study publicly available on registry
November 7, 2005
CompletedStudy Start
First participant enrolled
November 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2006
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedMarch 10, 2020
September 1, 2018
6 months
November 3, 2005
September 8, 2018
February 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination
Seroprotection after measles vaccination was defined as a measles antibody titer ≥ 120 mIU/mL. Measles immunoglobulin G (IgG) antibody was determined using the Enzygnost® Anti-Measles Virus/IgG enzyme-linked immunosorbent assay(ELISA) assay from Siemens, Marburg, Germany.
Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)
Secondary Outcomes (6)
Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination
Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)
Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination
Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)
Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination
Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Up to 7 days after LJEV administration
Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Up to 7 days after measles vaccination
- +1 more secondary outcomes
Study Arms (3)
LJEV then MV
EXPERIMENTALReceived one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) at 8 months of age, and one dose of measles vaccine (MV) one month later.
LJEV and MV
EXPERIMENTALReceived one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) concurrently with one dose of measles vaccine (MV) at 9 months of age.
MV then LJEV
EXPERIMENTALReceived one dose of measles vaccine (MV) at 9 months of age, followed by one dose of Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) one month later.
Interventions
Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) is lyophilized powder that looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid. Its container is a vial. It is stored and transported between 2°C to 8°C and protected from light. Each single human dose is 0.5 ml containing not less than 5.4 log particle flux unit (PFU) of live Japanese Encephalitis (JE) virus. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 200411129-3 manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China.
The Serum Institute of India (SII) measles vaccine provided routinely in the Expanded Program on Immunization (EPI) of the Philippines was the measles vaccine provided to the study participants. The vaccine met the requirements of the World Health Organization (WHO). SII measles vaccine contained live attenuated (freeze-dried) Edmonston-Zagreb strain measles virus propagated on human diploid cells (HDC). Each single human dose when reconstituted in a volume of 0.5 ml contains no less than 1000 Cell culture infectious dose 50% (CCID50) of live virus particles. SII measles vaccine is presented as a yellowish-white dry cake. The vaccine should be reconstituted with the diluent supplied (sterile water for injection). A sterile disposable syringe and needle are supplied separately. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 2979.
Eligibility Criteria
You may qualify if:
- Subject is a full-term infant
- Subject's parents or legal guardian willing to provide signed informed consent.
- Children have completed 3 doses each of diphtheria, tetanus, pertussis (DTP) and oral polio vaccine (OPV).
You may not qualify if:
- History of documented HIV.
- Known or suspected impairment of immunologic function.
- History of serious chronic disease
- Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- History of documented suspected encephalitis, encephalopathy, or meningitis
- History of measles
- History of thrombocytopenic purpura.
- Received any JE or measles vaccine prior to enrollment.
- Received any vaccine, other than the study vaccines, within 2 weeks prior to or scheduled to receive a non-study vaccination during the conduct of this trial.
- Hypotonic - hyporesponsiveness, after the preceding vaccination.
- History of seizures, including history of febrile seizures, or any other neurologic disorder.
- Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy except routine vaccines within 6 weeks of administration of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \<7 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment.
- Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
- Serious adverse event related to the vaccine (i.e., possible, probably, definite)
- Persistent inconsolable crying (\>3 hours) observed after a previous dose.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PATHlead
- Research Institute for Tropical Medicine, Manila, Philippinescollaborator
- Quintiles, Inc.collaborator
- Mahidol Universitycollaborator
Study Sites (1)
Research Institute for Tropical Medicine
Manila, Philippines
Related Publications (1)
Gatchalian S, Yao Y, Zhou B, Zhang L, Yoksan S, Kelly K, Neuzil KM, Yaich M, Jacobson J. Comparison of the immunogenicity and safety of measles vaccine administered alone or with live, attenuated Japanese encephalitis SA 14-14-2 vaccine in Philippine infants. Vaccine. 2008 Apr 24;26(18):2234-41. doi: 10.1016/j.vaccine.2008.02.042. Epub 2008 Mar 18.
PMID: 18394765RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jorge Flores
- Organization
- PATH
Study Officials
- PRINCIPAL INVESTIGATOR
Salvacion Gatchalian, MD
Research Institute for Tropical Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2005
First Posted
November 7, 2005
Study Start
November 21, 2005
Primary Completion
May 30, 2006
Study Completion
May 30, 2006
Last Updated
March 10, 2020
Results First Posted
March 10, 2020
Record last verified: 2018-09