Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine

• Sponsor: PATH (Other)
• Overall Status: Completed
• CT.gov ID: NCT00249769
• Collaborator: Research Institute for Tropical Medicine, Manila, Philippines (Other), Quintiles, Inc. (Industry), Mahidol University (Other)
• Enrollment: 600
• Location: 1
• Arms: 3
• Actual Duration (Months): 6.2
• Patients Per Site Per Month: 96.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Encephalitis, Japanese B	Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV); Biological: Measles Vaccine (MV)	Phase 3

Detailed Description

Japanese encephalitis is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral encephalitis in the world. Approximately 3 billion people-including 700 million children-live in Asian areas at risk for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.

An effective vaccine has existed since 1941, but has not reached the poorest countries in Asia. During the 60 years that the vaccine has been available, JE has infected an estimated 10.5 million children, resulting in more than 3 million deaths and more than 4 million children living with long-term disabilities. Control of this disease has been limited due to poor disease surveillance, a limited and unstable vaccine supply, lack of guidance and programmatic support for immunization, and limited advocacy.

A successful vaccine should be safe, efficacious, affordable, administered in a single dose, and easily incorporated into the routine Expanded Programmes on Immunization (EPI) programs. This study will help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. If this candidate becomes widely available, it will drastically increase the feasibility of routine JE immunization in Asia, reducing the devastating death and disability caused by this disease. In addition to impacting low-income countries, the vaccine will allow countries that purchase vaccine-such as Thailand, Vietnam, Sri Lanka, and India-to recover health care dollars, improve their present programs, and address other unmet health care needs.

Study Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Assessment of the Non-Inferiority of the Concurrent Administration of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Measles Vaccine Given Alone
• Actual Study Start Date: Nov 21, 2005
• Actual Primary Completion Date: May 30, 2006
• Actual Study Completion Date: May 30, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LJEV then MV Received 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.	Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV); 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.; Biological: Measles Vaccine (MV); 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.
Experimental: LJEV and MV Received 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.	Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV); 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.; Biological: Measles Vaccine (MV); 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.
Experimental: MV then LJEV Received 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.	Biological: Live Japanese encephalitis vaccine SA 14-14-2 (LJEV); 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.; Biological: Measles Vaccine (MV); 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.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination [Day 0 (before vaccination) and Day 28 (4 weeks after measles 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.

Secondary Outcome Measures

1. Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination [Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)]

   Seroprotection after LJEV was defined as at least 1:10 dilution as recommended by the World Health Organization (WHO). JE antibody titers were determined by a plaque reduction neutralization test (PRNT).

2. Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination [Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)]

   Measured using the Enzygnost® Anti-Measles Virus/IgG ELISA assay from Siemens, Marburg, Germany.

3. Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination [Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)]

   Assayed by plaque reduction neutralization test (PRNT).

4. Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV) [Up to 7 days after LJEV administration]

   Local reactions included erythema, pain, swelling, or induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, or fever. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.

5. Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine [Up to 7 days after measles vaccination]

   Local reactions included erythema, pain, swelling, and induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, and vomiting. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.

6. Number of Participants Experiencing Unsolicited Adverse Events (AE) [Up to 7 days post-vaccination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Months to 11 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participant is healthy, aged between 8 months (± 2 weeks) at inclusion visit

• 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).

Exclusion Criteria:

• 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.

• Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5°C at the time of inclusion.

• 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.

• Unable to attend the scheduled visits or comply with the study procedures.

• Enrolled in another clinical trial involving any therapy.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Institute for Tropical Medicine	Manila		Philippines

Sponsors and Collaborators

• PATH
• Research Institute for Tropical Medicine, Manila, Philippines
• Quintiles, Inc.
• Mahidol University

Investigators

• Principal Investigator: Salvacion Gatchalian, MD, Research Institute for Tropical Medicine,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PATH
• ClinicalTrials.gov Identifier: NCT00249769
• Other Study ID Numbers: JEV01
• First Posted: Nov 7, 2005
• Last Update Posted: Mar 10, 2020
• Last Verified: Sep 1, 2018

• Keywords provided by PATH: Japanese Encephalitis; Japanese B Encephalitis; Japanese B Viral Encephalitis; Viral Encephalitis, Japanese B
• Additional relevant MeSH terms: Encephalitis, Japanese; Encephalitis; Vaccines

Study Results

Participant Flow

Arm/Group Title	LJEV Then MV	LJEV and MV	MV Then LJEV
Arm/Group Description	Received 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.	Received 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.	Received 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.
Period Title: Overall Study
STARTED	100	250	250
Received LJEV	100	236	224
Received Measles Vaccine	97	236	235
COMPLETED	98	235	222
NOT COMPLETED	2	15	28

Baseline Characteristics

Arm/Group Title	LJEV Then MV	LJEV and MV	MV Then LJEV	Total
Arm/Group Description	Received 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.	Received 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.	Received 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.	Total of all reporting groups
Overall Participants	100	236	235	571
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	7.9 (0.3)	8.9 (0.3)	8.9 (0.3)	8.7 (0.5)
Sex: Female, Male (Count of Participants)
Female	48 48%	108 45.8%	128 54.5%	284 49.7%
Male	52 52%	128 54.2%	107 45.5%	287 50.3%
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	7.9 (1.0)	8.0 (1.0)	8.1 (1.0)	8.0 (1.0)
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	66.3 (2.6)	67.6 (2.7)	67.7 (2.6)	67.4 (2.7)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Seroprotection for Measles 4 Weeks After Vaccination
Description	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.
Time Frame	Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)

Outcome Measure Data

Analysis Population Description

The per-protocol population includes randomized participants who received at least one vaccine dose excluding participants who did not meet the inclusion/exclusion criteria or were found non-compliant to the immunization or blood sampling schedule. The analysis includes participants with valid serology results for measles antibody during retesting.

Arm/Group Title	LJEV Then MV	LJEV and MV	MV Then LJEV
Arm/Group Description	Received 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.	Received 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.	Received 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.
Measure Participants	88	219	178
Day 0	1.1 1.1%	0.0 0%	0.0 0%
Day 28	88.6 88.6%	91.8 38.9%	86.5 36.8%

2. Secondary Outcome

Title	Percentage of Participants With Seroprotection for Japanese Encephalitis 4 Weeks After Vaccination
Description	Seroprotection after LJEV was defined as at least 1:10 dilution as recommended by the World Health Organization (WHO). JE antibody titers were determined by a plaque reduction neutralization test (PRNT).
Time Frame	Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	LJEV Then MV	LJEV and MV	MV Then LJEV
Arm/Group Description	Received 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.	Received 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.	Received 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.
Measure Participants	88	222	180
Day 0	3.4 3.4%	5.4 2.3%	6.1 2.6%
Day 28	92.1 92.1%	90.5 38.3%	90.6 38.6%

3. Secondary Outcome

Title	Geometric Mean Concentration (GMC) of Measles Antibodies After Vaccination
Description	Measured using the Enzygnost® Anti-Measles Virus/IgG ELISA assay from Siemens, Marburg, Germany.
Time Frame	Day 0 (before vaccination) and Day 28 (4 weeks after measles vaccination)

Outcome Measure Data

Analysis Population Description

Per-protocol population; the analysis includes participants with valid serology results for measles antibody during retesting.

Arm/Group Title	LJEV Then MV	LJEV and MV	MV Then LJEV
Arm/Group Description	Received 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.	Received 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.	Received 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.
Measure Participants	88	219	178
Day 0	12.8	7.4	7.0
Day 28	318.9	301.9	262.5

4. Secondary Outcome

Title	Geometric Mean Titer (GMT) of Japanese Encephalitis Antibodies After Vaccination
Description	Assayed by plaque reduction neutralization test (PRNT).
Time Frame	Day 0 (before vaccination) and Day 28 (4 weeks after LJEV vaccination)

Outcome Measure Data

Analysis Population Description

Per-protocol population

Arm/Group Title	LJEV Then MV	LJEV and MV	MV Then LJEV
Arm/Group Description	Received 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.	Received 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.	Received 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.
Measure Participants	88	219	178
Day 0	5.7	5.7	5.9
Day 28	202.8	155.0	139.4

5. Secondary Outcome

Title	Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Live Attenuated Japanese Encephalitis Vaccine (LJEV)
Description	Local reactions included erythema, pain, swelling, or induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, or fever. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.
Time Frame	Up to 7 days after LJEV administration

Outcome Measure Data

Analysis Population Description

Participants who received LJEV

Arm/Group Title	LJEV Then MV	LJEV and MV	MV Then LJEV
Arm/Group Description	Received 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.	Received 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.	Received 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.
Measure Participants	100	236	224
Local reactions: any	27 27%	53 22.5%	27 11.5%
Local reactions: mild	19 19%	48 20.3%	22 9.4%
Local reactions: moderate	8 8%	5 2.1%	5 2.1%
Local reactions: severe	0 0%	0 0%	0 0%
Systemic reactions: any	58 58%	97 41.1%	88 37.4%
Systemic reaction: mild	34 34%	53 22.5%	56 23.8%
Systemic reaction: moderate	22 22%	37 15.7%	30 12.8%
Systemic reaction: severe	2 2%	7 3%	2 0.9%
Fever: any	24 24%	52 22%	57 24.3%
Fever: 37.5-38.6°C	18 18%	38 16.1%	47 20%
Fever: 38.7-39.9°C	6 6%	14 5.9%	10 4.3%
Fever: ≥ 40°C	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants Experiencing Local and Systemic Reactogenicity After Receiving Measles Vaccine
Description	Local reactions included erythema, pain, swelling, and induration. Systemic reactions included loss of appetite, crying, diarrhea, drowsiness, insomnia, irritability, and vomiting. The parents of the participants recorded all local reactions and systemic events on an individual safety diary form.
Time Frame	Up to 7 days after measles vaccination

Outcome Measure Data

Analysis Population Description

Participants who received measles vaccine

Arm/Group Title	LJEV Then MV	LJEV and MV	MV Then LJEV
Arm/Group Description	Received 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.	Received 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.	Received 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.
Measure Participants	97	236	235
Local reactions: any	19 19%	44 18.6%	61 26%
Local reactions: mild	15 15%	42 17.8%	50 21.3%
Local reactions: moderate	4 4%	2 0.8%	11 4.7%
Local reactions: severe	0 0%	0 0%	0 0%
Systemic reactions: any	49 49%	97 41.1%	122 51.9%
Systemic reaction: mild	31 31%	53 22.5%	77 32.8%
Systemic reaction: moderate	13 13%	37 15.7%	42 17.9%
Systemic reaction: severe	5 5%	7 3%	3 1.3%
Fever: any	31 31%	52 22%	64 27.2%
Fever: 37.5-38.6°C	21 21%	38 16.1%	52 22.1%
Fever: 38.7-39.9°C	10 10%	14 5.9%	12 5.1%
Fever: ≥ 40°C	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants Experiencing Unsolicited Adverse Events (AE)
Time Frame	Up to 7 days post-vaccination

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	LJEV Then MV	LJEV and MV	MV Then LJEV
Arm/Group Description	Received 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.	Received 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.	Received 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.
Measure Participants	100	236	235
Any Adverse Event	35 35%	43 18.2%	79 33.6%
Related adverse event	0 0%	4 1.7%	2 0.9%
Serious adverse event	2 2%	0 0%	3 1.3%

Adverse Events

Time Frame	1 month for serious adverse events and 7 days for non-serious adverse events
Arm/Group Title	LJEV Then MV		LJEV and MV		MV Then LJEV
Arm/Group Description	Received 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.		Received 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.		Received 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.
All Cause Mortality
	LJEV Then MV		LJEV and MV		MV Then LJEV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/236 (0%)		0/235 (0%)
Serious Adverse Events
	LJEV Then MV		LJEV and MV		MV Then LJEV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/100 (5%)		0/236 (0%)		7/235 (3%)
Gastrointestinal disorders
Amoebiasis	1/100 (1%)		0/236 (0%)		2/235 (0.9%)
Acute Gastroenteritis	2/100 (2%)		0/236 (0%)		1/235 (0.4%)
Infections and infestations
Pneumonia	1/100 (1%)		0/236 (0%)		0/235 (0%)
Injury, poisoning and procedural complications
Animal bite	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Nervous system disorders
Complex Febrile Seizure	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Renal and urinary disorders
Urinary tract infection	1/100 (1%)		0/236 (0%)		1/235 (0.4%)
Respiratory, thoracic and mediastinal disorders
Bronchial Asthma	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Other (Not Including Serious) Adverse Events
	LJEV Then MV		LJEV and MV		MV Then LJEV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/100 (34%)		43/236 (18.2%)		78/235 (33.2%)
Eye disorders
Viral conjunctivitis	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Conjunctivitis	0/100 (0%)		1/236 (0.4%)		1/235 (0.4%)
Gastrointestinal disorders
Acute gastroenteritis	8/100 (8%)		7/236 (3%)		8/235 (3.4%)
Intestinal parasitism	0/100 (0%)		1/236 (0.4%)		0/235 (0%)
Oral candidiasis	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Stomatitis	1/100 (1%)		0/236 (0%)		1/235 (0.4%)
Immune system disorders
Bronchial asthma	0/100 (0%)		0/236 (0%)		2/235 (0.9%)
Infections and infestations
Acute bronchitis	4/100 (4%)		1/236 (0.4%)		5/235 (2.1%)
Acute otitis media	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Acute Tonsillopharyngitis	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Bacterial conjunctivitis	1/100 (1%)		0/236 (0%)		0/235 (0%)
Cellulitis	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Enteric fever	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Pneumonia	0/100 (0%)		2/236 (0.8%)		1/235 (0.4%)
Roseola infantum	0/100 (0%)		1/236 (0.4%)		0/235 (0%)
Systemic viral infection	4/100 (4%)		0/236 (0%)		2/235 (0.9%)
Urinary tract infection	1/100 (1%)		0/236 (0%)		1/235 (0.4%)
Injury, poisoning and procedural complications
Concussion	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Infected wound	0/100 (0%)		1/236 (0.4%)		0/235 (0%)
Insect bite	0/100 (0%)		1/236 (0.4%)		0/235 (0%)
Respiratory, thoracic and mediastinal disorders
Acute rhinitis	6/100 (6%)		6/236 (2.5%)		10/235 (4.3%)
Upper respiratory tract infection	14/100 (14%)		18/236 (7.6%)		42/235 (17.9%)
Skin and subcutaneous tissue disorders
Atopic dermatitis	0/100 (0%)		1/236 (0.4%)		0/235 (0%)
Dermatitis	0/100 (0%)		3/236 (1.3%)		0/235 (0%)
Impetigo contagious	0/100 (0%)		0/236 (0%)		1/235 (0.4%)
Maculo-papular lesions	0/100 (0%)		1/236 (0.4%)		0/235 (0%)
Miliaria	0/100 (0%)		0/236 (0%)		2/235 (0.9%)
Rash	0/100 (0%)		1/236 (0.4%)		0/235 (0%)
Furuncle	0/100 (0%)		3/236 (1.3%)		1/235 (0.4%)
Surgical and medical procedures
Post-extraction hematoma	0/100 (0%)		1/236 (0.4%)		2/235 (0.9%)
Post-vaccination reaction	0/100 (0%)		1/236 (0.4%)		0/235 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.