Trial Outcomes & Findings for Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age (NCT NCT00463684)
NCT ID: NCT00463684
Last Updated: 2019-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
278 participants
Primary outcome timeframe
1 year
Results posted on
2019-02-08
Participant Flow
Potential subject children were identified through Ministry of Health (MOH) birth and immunization registries of selected vaccination clinics.
Participant milestones
| Measure |
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.
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 Study
STARTED
|
278
|
|
Overall Study
COMPLETED
|
274
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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.
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 Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age
Baseline characteristics by cohort
| Measure |
All Subjects
n=278 Participants
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.
|
|---|---|
|
Age, Continuous
|
9.2 months
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
|
Region of Enrollment
Sri Lanka
|
278 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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).
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.
Outcome measures
| Measure |
All Subjects
n=257 Participants
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.
|
|---|---|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies
Day 0 · Yes
|
14 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies
Day 0 · No
|
243 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies
Day 28 · Yes
|
233 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies
Day 28 · No
|
24 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies
6 months · Yes
|
202 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies
6 months · No
|
41 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies
1 year · Yes
|
221 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies
1 year · No
|
32 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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).
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).
Outcome measures
| Measure |
All Subjects
n=257 Participants
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.
|
|---|---|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition
Day 0 · Yes
|
0 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition
Day 0 · No
|
257 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition
Day 28 · Yes
|
218 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition
Day 28 · No
|
39 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition
6 months · Yes
|
229 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition
6 months · No
|
14 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition
1 year · Yes
|
246 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition
1 year · No
|
7 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 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).
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).
Outcome measures
| Measure |
All Subjects
n=257 Participants
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.
|
|---|---|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects
Day 0 · Yes
|
0 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects
Day 0 · No
|
257 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects
Day 28 · Yes
|
244 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects
Day 28 · No
|
13 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects
6 months · Yes
|
229 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects
6 months · No
|
14 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects
1 year · Yes
|
246 Participants
|
|
Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects
1 year · No
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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).
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%.
Outcome measures
| Measure |
All Subjects
n=257 Participants
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.
|
|---|---|
|
Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies
Day 0
|
5.5 titer
Interval 5.2 to 5.8
|
|
Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies
Day 28
|
110.6 titer
Interval 90.3 to 135.4
|
|
Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies
6 months
|
68.3 titer
Interval 55.3 to 83.4
|
|
Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies
1 year
|
75.5 titer
Interval 62.2 to 91.6
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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).
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).
Outcome measures
| Measure |
All Subjects
n=257 Participants
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.
|
|---|---|
|
Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG)
Day 0
|
20.5 titer
Interval 18.4 to 22.8
|
|
Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG)
Day 28
|
374.9 titer
Interval 351.0 to 400.4
|
|
Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG)
6 months
|
697.8 titer
Interval 634.0 to 768.0
|
|
Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG)
1 year
|
1201.7 titer
Interval 1076.7 to 1341.3
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Not all subjects were followed for a full 30 minutes after injection.
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.
Outcome measures
| Measure |
All Subjects
n=278 Participants
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.
|
|---|---|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Immediate reaction · Yes
|
0 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Immediate reaction · No
|
254 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited local reaction: LJEV, Days 0-3 · Yes
|
34 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited local reaction: LJEV, Days 0-3 · No
|
244 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited local reaction: measles, Days 0-3 · Yes
|
27 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited local reaction: measles, Days 0-3 · No
|
251 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited local reactions, LJEV: Days 4-7 · Yes
|
2 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited local reactions, LJEV: Days 4-7 · No
|
276 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited local reactions, measles: Days 4-7 · Yes
|
1 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited local reactions, measles: Days 4-7 · No
|
277 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited systemic reaction, days 0-7 · Yes
|
112 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited systemic reaction, days 0-7 · No
|
166 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited systemic reaction, >7 days · Yes
|
18 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Solicited systemic reaction, >7 days · No
|
260 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Unsolicited systemic reactions, Days 0-7 · Yes
|
30 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Unsolicited systemic reactions, Days 0-7 · No
|
248 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Unsolicited systemic reactions, >7 days · Yes
|
14 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Unsolicited systemic reactions, >7 days · No
|
264 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Any non-serious adverse event · Yes
|
122 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Any non-serious adverse event · No
|
156 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Related adverse events · Yes
|
0 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Related adverse events · No
|
278 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Serious adverse events, Days 8-365 · Yes
|
45 Participants
|
|
Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)
Serious adverse events, Days 8-365 · No
|
233 Participants
|
SECONDARY outcome
Timeframe: 3 daysParents 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.
Outcome measures
| Measure |
All Subjects
n=278 Participants
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.
|
|---|---|
|
Number of Solicited Local Reactions to LJEV: Days 0-3
Any solicited local reaction: Any severity
|
34 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 0-3
Any solicited local reaction: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 0-3
Erythema: Any severity
|
11 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 0-3
Erythema: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 0-3
Induration: Any severity
|
7 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 0-3
Induration: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 0-3
Pain: Any severity
|
25 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 0-3
Pain: Grade 3
|
0 reactions
|
SECONDARY outcome
Timeframe: 4 daysParents 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.
Outcome measures
| Measure |
All Subjects
n=278 Participants
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.
|
|---|---|
|
Number of Solicited Local Reactions to LJEV: Days 4-7
Any solicited local reaction: Any severity
|
2 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 4-7
Any solicited local reaction: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 4-7
Erythema: Any severity
|
1 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 4-7
Erythema: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 4-7
Induration: Any severity
|
0 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 4-7
Induration: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 4-7
Pain: Any severity
|
1 reactions
|
|
Number of Solicited Local Reactions to LJEV: Days 4-7
Pain: Grade 3
|
0 reactions
|
SECONDARY outcome
Timeframe: 3 daysParents 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.
Outcome measures
| Measure |
All Subjects
n=278 Participants
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.
|
|---|---|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 0-3
Any solicited local reaction: Any severity
|
27 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 0-3
Any solicited local reaction: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 0-3
Erythema: Any severity
|
11 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 0-3
Erythema: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 0-3
Induration: Any severity
|
6 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 0-3
Induration: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 0-3
Pain: Any severity
|
21 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 0-3
Pain: Grade 3
|
0 reactions
|
SECONDARY outcome
Timeframe: 4 daysParents 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.
Outcome measures
| Measure |
All Subjects
n=278 Participants
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.
|
|---|---|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 4-7
Any solicited local reaction: Any severity
|
1 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 4-7
Any solicited local reaction: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 4-7
Erythema: Any severity
|
1 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 4-7
Erythema: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 4-7
Induration: Any severity
|
0 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 4-7
Induration: Grade 3
|
0 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 4-7
Pain: Any severity
|
0 reactions
|
|
Number of Solicited Local Reactions to Measles Vaccine: Days 4-7
Pain: Grade 3
|
0 reactions
|
SECONDARY outcome
Timeframe: 3 daysParents 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.
Outcome measures
| Measure |
All Subjects
n=278 Participants
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.
|
|---|---|
|
Number of Solicited Systemic Reactions: Days 0-3
Any solicited systemic reaction: Any severity
|
105 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Any solicited systemic reaction: Grade 3
|
4 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Fever: Any severity
|
21 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Fever: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Anorexia: Any severity
|
52 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Anorexia: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Crying: Any severity
|
56 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Crying: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Diarrhea: any severity
|
27 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Diarrhea: Grade 3
|
2 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Tiredness: Any severity
|
32 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Tiredness: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Insomnia: Any severity
|
33 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Insomnia: Grade 3
|
1 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Irritability: Any severity
|
17 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Irritability: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Vomiting: Any severity
|
17 reactions
|
|
Number of Solicited Systemic Reactions: Days 0-3
Vomiting: Grade 3
|
1 reactions
|
SECONDARY outcome
Timeframe: 4 daysParents 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.
Outcome measures
| Measure |
All Subjects
n=278 Participants
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.
|
|---|---|
|
Number of Solicited Systemic Reactions: Days 4-7
Any solicited systemic reaction: Any severity
|
55 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Any solicited systemic reaction: Grade 3
|
2 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Fever: Any severity
|
14 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Fever: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Anorexia: Any severity
|
32 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Anorexia: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Crying: Any severity
|
18 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Crying: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Diarrhea: any severity
|
19 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Diarrhea: Grade 3
|
2 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Tiredness: Any severity
|
11 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Tiredness: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Insomnia: Any severity
|
15 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Insomnia: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Irritability: Any severity
|
10 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Irritability: Grade 3
|
0 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Vomiting: Any severity
|
6 reactions
|
|
Number of Solicited Systemic Reactions: Days 4-7
Vomiting: Grade 3
|
0 reactions
|
Adverse Events
All Subjects
Serious events: 45 serious events
Other events: 122 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Subjects
n=278 participants at risk
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.
|
|---|---|
|
Eye disorders
Conjunctivitis
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Gastrointestinal disorders
Anal skin tags
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
General disorders
Gait disturbance
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
General disorders
Pyrexia
|
1.1%
3/278 • Number of events 3 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Bacterial infection
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Bronchiolitis
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Bronchitis
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Bronchopneumonia
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Dysentery
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Eczema infected
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
11/278 • Number of events 13 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Gastroenteritis viral
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.5%
7/278 • Number of events 7 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Otitis media acute
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Subcutaneous abscess
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Tonsillitis
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.72%
2/278 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Viral infection
|
2.9%
8/278 • Number of events 9 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.36%
1/278 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Nervous system disorders
Febrile convulsion
|
1.1%
3/278 • Number of events 4 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Reproductive system and breast disorders
Genital labial adhesions
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
Other adverse events
| Measure |
All Subjects
n=278 participants at risk
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.
|
|---|---|
|
Eye disorders
Conjunctivitis
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Gastrointestinal disorders
Anal skin tags
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
12/278 • Number of events 13 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
8/278 • Number of events 9 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Gastrointestinal disorders
Gait disturbance
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Gastrointestinal disorders
Pyrexia
|
13.7%
38/278 • Number of events 39 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Immune system disorders
Food allergy
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Acarodermatitis
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Bacterial infection
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Bronchiolitis
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Bronchitis
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Bronchopneumonia
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Dysentery
|
0.36%
1/278 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Ear infection
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Eczema infected
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
11/278 • Number of events 12 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Impetigo
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Infection
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.6%
10/278 • Number of events 10 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
12.2%
34/278 • Number of events 35 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Otitis media acute
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Rash pustular
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Subcutaneous abscess
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Tonsillitis
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
3/278 • Number of events 3 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.72%
2/278 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Infections and infestations
Viral infection
|
2.9%
8/278 • Number of events 9 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Nervous system disorders
Febrile convulsion
|
1.1%
3/278 • Number of events 4 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Nervous system disorders
Headache
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Psychiatric disorders
Crying
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Reproductive system and breast disorders
Genital labial adhesions
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.5%
46/278 • Number of events 46 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.9%
8/278 • Number of events 8 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.9%
8/278 • Number of events 8 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
3/278 • Number of events 3 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.36%
1/278 • Number of events 1 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.72%
2/278 • Number of events 2 • 1 year for serious adverse events, 28 days for non-serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place