Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age (JEV03)
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ClinicalTrials.gov Identifier: NCT00463684 |
Recruitment Status :
Completed
First Posted : April 20, 2007
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
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Condition or disease | Intervention/treatment | Phase |
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Japanese Encephalitis | Biological: Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine Biological: Live, attenuated measles vaccine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 278 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Assessment of the Immunogenicity and Safety of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine in Children in Sri Lanka |
Study Start Date : | July 7, 2007 |
Actual Primary Completion Date : | November 7, 2007 |
Actual Study Completion Date : | October 6, 2008 |

Arm | Intervention/treatment |
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Experimental: All subjects
Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine.
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Biological: Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine
Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Biological: Live, attenuated measles vaccine Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
- Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies [ Time Frame: 1 year ]Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%. Seropositivity was defined as a titer of ≥1:10.
- Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition [ Time Frame: 1 year ]Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of>200 mIU/mL, this table) and when including those with "borderline" results (≥150 mIU/mL).
- Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects [ Time Frame: 1 year ]Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of>200 mIU/mL) and when including those with "borderline" results (≥150 mIU/mL, this table).
- Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies [ Time Frame: 1 year ]Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%.
- Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG) [ Time Frame: 1 year ]Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of>200 mIU/mL, this table) and when including those with "borderline" results (≥150 mIU/mL).
- Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) [ Time Frame: 1 year ]Subjects were monitored for immediate AEs and local reactions for 30 minutes after each injection by a study physician. Thereafter, parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days afterwards. Study staff called the subjects' parents 2 days after vaccination and monthly through 1 year to inquire about the child's well being and review the diary card. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card. The subject returned to the vaccination clinic on Day 28, 6 months, and 1 year to be examined, have a blood draw, and review any AEs or serious adverse events (SAE) with parents.
- Number of Solicited Local Reactions to LJEV: Days 0-3 [ Time Frame: 3 days ]Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.
- Number of Solicited Local Reactions to LJEV: Days 4-7 [ Time Frame: 4 days ]Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.
- Number of Solicited Local Reactions to Measles Vaccine: Days 0-3 [ Time Frame: 3 days ]Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.
- Number of Solicited Local Reactions to Measles Vaccine: Days 4-7 [ Time Frame: 4 days ]Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.
- Number of Solicited Systemic Reactions: Days 0-3 [ Time Frame: 3 days ]Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.
- Number of Solicited Systemic Reactions: Days 4-7 [ Time Frame: 4 days ]Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card.

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Ages Eligible for Study: | 9 Months to 9 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy child 9 months (±2 weeks) of age at the enrollment visit.
- Subject was a full-term infant.
- Subject's parent or legal guardian is literate and willing to provide written informed consent.
- Subject is up-to-date for all vaccinations recommended in the Sri Lankan childhood immunization schedule.
Exclusion Criteria:
- Enrolled in another clinical trial involving any therapy.
- Subject and/or parent(s) or guardian(s) are unable to attend the scheduled visits or comply with the study procedures.
- Received any non-study vaccine within 2 weeks prior to enrolment or refusal to postpone receipt of such vaccines until 28 days after study entry.
- 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 study vaccine. 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 enrolment.
- History of documented or suspected encephalitis, encephalopathy, or meningitis.
- History of measles.
- History of Japanese encephalitis.
- Serious adverse event related (i.e., possible, probably, definite) to previous receipt of any JE vaccine, if applicable.
- Persistent inconsolable crying (>3 hours) observed after previous receipt of any JE vaccine, if applicable.
- Hypotonic - hyporesponsiveness after past receipt of any JE vaccine, if applicable.
- Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
- History of serious chronic disease (cardiac, renal, neurologic, metabolic, or rheumatologic).
- 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 thrombocytopenic purpura.
- History of seizures, including history of febrile seizures, or any other neurologic disorder.
- Known or suspected immunologic function impairment of any kind and/or known HIV infection.
- Parent with known or suspected immunologic function impairment of any kind and/or known HIV infection.
- Any condition that, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the study objectives.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463684
Sri Lanka | |
Homagama MOH Division Medical Office | |
Homagama, District Of Colombo, Sri Lanka | |
Kolonnawa MOH Division Medical Office | |
Kolonnawa, District Of Colombo, Sri Lanka | |
Moratuwa MOH Division Medical Office | |
Moratuwa, District Of Colombo, Sri Lanka |
Principal Investigator: | Nihal Abeysinghe, MD, MSc | Epidemiological Unit, Sri Lanka Ministry of Healthcare and Nutrition |
ClinicalTrials.gov Identifier: | NCT00463684 |
Other Study ID Numbers: |
JEV03 |
First Posted: | April 20, 2007 Key Record Dates |
Results First Posted: | February 8, 2019 |
Last Update Posted: | February 8, 2019 |
Last Verified: | September 2018 |
Encephalitis, Japanese Encephalitis Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalitis, Arbovirus Encephalitis, Viral Central Nervous System Viral Diseases Central Nervous System Infections Infections |
Infectious Encephalitis Arbovirus Infections Vector Borne Diseases Virus Diseases RNA Virus Infections Flavivirus Infections Flaviviridae Infections Vaccines Immunologic Factors Physiological Effects of Drugs |