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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
Sponsor:
Collaborators:
Ministry of Health of Sri Lanka
Mahidol University
Quintiles Singapore
Information provided by:
PATH

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Japanese Encephalitis
Interventions Biological: Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine
Biological: Live, attenuated measles vaccine
Enrollment 278
Recruitment Details Potential subject children were identified through Ministry of Health (MOH) birth and immunization registries of selected vaccination clinics.
Pre-assignment Details  
Arm/Group Title All Subjects
Hide Arm/Group Description

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Period Title: Overall Study
Started 278
Completed 274
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             3
Arm/Group Title All Subjects
Hide Arm/Group Description

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Baseline Participants 278
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 278 participants
9.2  (0.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 278 participants
Female
148
  53.2%
Male
130
  46.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sri Lanka Number Analyzed 278 participants
278
1.Primary Outcome
Title Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 257
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0 Number Analyzed 257 participants
Yes
14
   5.4%
No
243
  94.6%
Day 28 Number Analyzed 257 participants
Yes
233
  90.7%
No
24
   9.3%
6 months Number Analyzed 243 participants
Yes
202
  83.1%
No
41
  16.9%
1 year Number Analyzed 253 participants
Yes
221
  87.4%
No
32
  12.6%
2.Primary Outcome
Title Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition
Hide Description 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).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 257
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0 Number Analyzed 257 participants
Yes
0
   0.0%
No
257
 100.0%
Day 28 Number Analyzed 257 participants
Yes
218
  84.8%
No
39
  15.2%
6 months Number Analyzed 243 participants
Yes
229
  94.2%
No
14
   5.8%
1 year Number Analyzed 253 participants
Yes
246
  97.2%
No
7
   2.8%
3.Primary Outcome
Title Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects
Hide Description 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).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 257
Measure Type: Count of Participants
Unit of Measure: Participants
Day 0 Number Analyzed 257 participants
Yes
0
   0.0%
No
257
 100.0%
Day 28 Number Analyzed 257 participants
Yes
244
  94.9%
No
13
   5.1%
6 months Number Analyzed 243 participants
Yes
229
  94.2%
No
14
   5.8%
1 year Number Analyzed 253 participants
Yes
246
  97.2%
No
7
   2.8%
4.Secondary Outcome
Title Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies
Hide Description 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%.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 257
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0 Number Analyzed 257 participants
5.5
(5.2 to 5.8)
Day 28 Number Analyzed 257 participants
110.6
(90.3 to 135.4)
6 months Number Analyzed 243 participants
68.3
(55.3 to 83.4)
1 year Number Analyzed 253 participants
75.5
(62.2 to 91.6)
5.Secondary Outcome
Title Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG)
Hide Description 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).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28).
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 257
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
20.5
(18.4 to 22.8)
Day 28
374.9
(351.0 to 400.4)
6 months
697.8
(634.0 to 768.0)
1 year
1201.7
(1076.7 to 1341.3)
6.Secondary Outcome
Title Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Not all subjects were followed for a full 30 minutes after injection.
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 278
Measure Type: Count of Participants
Unit of Measure: Participants
Immediate reaction Number Analyzed 254 participants
Yes
0
   0.0%
No
254
 100.0%
Solicited local reaction: LJEV, Days 0-3 Number Analyzed 278 participants
Yes
34
  12.2%
No
244
  87.8%
Solicited local reaction: measles, Days 0-3 Number Analyzed 278 participants
Yes
27
   9.7%
No
251
  90.3%
Solicited local reactions, LJEV: Days 4-7 Number Analyzed 278 participants
Yes
2
   0.7%
No
276
  99.3%
Solicited local reactions, measles: Days 4-7 Number Analyzed 278 participants
Yes
1
   0.4%
No
277
  99.6%
Solicited systemic reaction, days 0-7 Number Analyzed 278 participants
Yes
112
  40.3%
No
166
  59.7%
Solicited systemic reaction, >7 days Number Analyzed 278 participants
Yes
18
   6.5%
No
260
  93.5%
Unsolicited systemic reactions, Days 0-7 Number Analyzed 278 participants
Yes
30
  10.8%
No
248
  89.2%
Unsolicited systemic reactions, >7 days Number Analyzed 278 participants
Yes
14
   5.0%
No
264
  95.0%
Any non-serious adverse event Number Analyzed 278 participants
Yes
122
  43.9%
No
156
  56.1%
Related adverse events Number Analyzed 278 participants
Yes
0
   0.0%
No
278
 100.0%
Serious adverse events, Days 8-365 Number Analyzed 278 participants
Yes
45
  16.2%
No
233
  83.8%
7.Secondary Outcome
Title Number of Solicited Local Reactions to LJEV: Days 0-3
Hide Description 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.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: reactions
Any solicited local reaction: Any severity 34
Any solicited local reaction: Grade 3 0
Erythema: Any severity 11
Erythema: Grade 3 0
Induration: Any severity 7
Induration: Grade 3 0
Pain: Any severity 25
Pain: Grade 3 0
8.Secondary Outcome
Title Number of Solicited Local Reactions to LJEV: Days 4-7
Hide Description 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.
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: reactions
Any solicited local reaction: Any severity 2
Any solicited local reaction: Grade 3 0
Erythema: Any severity 1
Erythema: Grade 3 0
Induration: Any severity 0
Induration: Grade 3 0
Pain: Any severity 1
Pain: Grade 3 0
9.Secondary Outcome
Title Number of Solicited Local Reactions to Measles Vaccine: Days 0-3
Hide Description 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.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: reactions
Any solicited local reaction: Any severity 27
Any solicited local reaction: Grade 3 0
Erythema: Any severity 11
Erythema: Grade 3 0
Induration: Any severity 6
Induration: Grade 3 0
Pain: Any severity 21
Pain: Grade 3 0
10.Secondary Outcome
Title Number of Solicited Local Reactions to Measles Vaccine: Days 4-7
Hide Description 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.
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: reactions
Any solicited local reaction: Any severity 1
Any solicited local reaction: Grade 3 0
Erythema: Any severity 1
Erythema: Grade 3 0
Induration: Any severity 0
Induration: Grade 3 0
Pain: Any severity 0
Pain: Grade 3 0
11.Secondary Outcome
Title Number of Solicited Systemic Reactions: Days 0-3
Hide Description 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.
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: reactions
Any solicited systemic reaction: Any severity 105
Any solicited systemic reaction: Grade 3 4
Fever: Any severity 21
Fever: Grade 3 0
Anorexia: Any severity 52
Anorexia: Grade 3 0
Crying: Any severity 56
Crying: Grade 3 0
Diarrhea: any severity 27
Diarrhea: Grade 3 2
Tiredness: Any severity 32
Tiredness: Grade 3 0
Insomnia: Any severity 33
Insomnia: Grade 3 1
Irritability: Any severity 17
Irritability: Grade 3 0
Vomiting: Any severity 17
Vomiting: Grade 3 1
12.Secondary Outcome
Title Number of Solicited Systemic Reactions: Days 4-7
Hide Description 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.
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Overall Number of Participants Analyzed 278
Measure Type: Number
Unit of Measure: reactions
Any solicited systemic reaction: Any severity 55
Any solicited systemic reaction: Grade 3 2
Fever: Any severity 14
Fever: Grade 3 0
Anorexia: Any severity 32
Anorexia: Grade 3 0
Crying: Any severity 18
Crying: Grade 3 0
Diarrhea: any severity 19
Diarrhea: Grade 3 2
Tiredness: Any severity 11
Tiredness: Grade 3 0
Insomnia: Any severity 15
Insomnia: Grade 3 0
Irritability: Any severity 10
Irritability: Grade 3 0
Vomiting: Any severity 6
Vomiting: Grade 3 0
Time Frame 1 year for serious adverse events, 28 days for non-serious adverse events.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description

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.

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.

Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   0/278 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%) # Events
Total   45/278 (16.19%)    
Eye disorders   
Conjunctivitis   1/278 (0.36%)  1
Gastrointestinal disorders   
Anal skin tags   1/278 (0.36%)  1
Constipation   1/278 (0.36%)  1
General disorders   
Gait disturbance   1/278 (0.36%)  1
Pyrexia   3/278 (1.08%)  3
Infections and infestations   
Bacterial infection   1/278 (0.36%)  1
Bronchiolitis   1/278 (0.36%)  1
Bronchitis   1/278 (0.36%)  1
Bronchopneumonia   1/278 (0.36%)  1
Dysentery   1/278 (0.36%)  1
Eczema infected   1/278 (0.36%)  1
Gastroenteritis   11/278 (3.96%)  13
Gastroenteritis viral   1/278 (0.36%)  1
Lower respiratory tract infection   7/278 (2.52%)  7
Otitis media acute   1/278 (0.36%)  1
Subcutaneous abscess   1/278 (0.36%)  1
Tonsillitis   1/278 (0.36%)  1
Urinary tract infection   2/278 (0.72%)  2
Viral infection   8/278 (2.88%)  9
Injury, poisoning and procedural complications   
Concussion   1/278 (0.36%)  1
Ear injury   1/278 (0.36%)  1
Laceration   1/278 (0.36%)  2
Thermal burn   1/278 (0.36%)  1
Nervous system disorders   
Febrile convulsion   3/278 (1.08%)  4
Reproductive system and breast disorders   
Genital labial adhesions   1/278 (0.36%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma   1/278 (0.36%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Subjects
Affected / at Risk (%) # Events
Total   122/278 (43.88%)    
Eye disorders   
Conjunctivitis   1/278 (0.36%)  1
Gastrointestinal disorders   
Anal skin tags   1/278 (0.36%)  1
Constipation   1/278 (0.36%)  1
Diarrhoea   12/278 (4.32%)  13
Vomiting   8/278 (2.88%)  9
Gait disturbance   1/278 (0.36%)  1
Pyrexia   38/278 (13.67%)  39
Gastroenteritis viral   1/278 (0.36%)  1
Immune system disorders   
Food allergy   1/278 (0.36%)  1
Infections and infestations   
Acarodermatitis   1/278 (0.36%)  1
Bacterial infection   1/278 (0.36%)  1
Bronchiolitis   1/278 (0.36%)  1
Bronchitis   1/278 (0.36%)  1
Bronchopneumonia   1/278 (0.36%)  1
Dysentery   1/278 (0.36%) 
Ear infection   1/278 (0.36%)  1
Eczema infected   1/278 (0.36%)  1
Gastroenteritis   11/278 (3.96%)  12
Impetigo   1/278 (0.36%)  1
Infection   1/278 (0.36%)  1
Lower respiratory tract infection   10/278 (3.60%)  10
Nasopharyngitis   34/278 (12.23%)  35
Otitis media acute   1/278 (0.36%)  1
Rash pustular   1/278 (0.36%)  1
Subcutaneous abscess   1/278 (0.36%)  1
Tonsillitis   1/278 (0.36%)  1
Upper respiratory tract infection   3/278 (1.08%)  3
Urinary tract infection   2/278 (0.72%)  2
Viral infection   8/278 (2.88%)  9
Injury, poisoning and procedural complications   
Concussion   1/278 (0.36%)  1
Ear injury   1/278 (0.36%)  1
Laceration   1/278 (0.36%)  1
Thermal burn   1/278 (0.36%)  1
Nervous system disorders   
Febrile convulsion   3/278 (1.08%)  4
Headache   1/278 (0.36%)  1
Psychiatric disorders   
Crying   1/278 (0.36%)  1
Reproductive system and breast disorders   
Genital labial adhesions   1/278 (0.36%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma   1/278 (0.36%)  1
Cough   46/278 (16.55%)  46
Productive cough   1/278 (0.36%)  1
Rhinorrhoea   8/278 (2.88%)  8
Wheezing   8/278 (2.88%)  8
Skin and subcutaneous tissue disorders   
Dermatitis allergic   1/278 (0.36%)  1
Rash   3/278 (1.08%)  3
Rash erythematous   1/278 (0.36%)  1
Rash papular   2/278 (0.72%)  2
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Jorge Flores
Organization: PATH
Phone: (202) 822-0033
ClinicalTrials.gov Identifier: NCT00463684     History of Changes
Other Study ID Numbers: JEV03
First Submitted: April 18, 2007
First Posted: April 20, 2007
Results First Submitted: September 11, 2018
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019