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| ID | Type | Description | Link |
|---|---|---|---|
| PR-15036 | Other Identifier | International Centre for Diarrhoeal Disease Research, Bangladesh |
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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
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This study aims to understand the persistence of the Japanese encephalitis (JE) antibody response in previously vaccinated children. The proposed study will enrol Bangladeshi children who had previously participated in a lot to lot consistency study (JEV05; NCT01567865) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).
Study participants previously immunized with CD-JEV (Clinical Trials identifier: NCT01567865, JEV05) will have serum collected three and four years after initial vaccination to assess long-term immunogenicity. Four years after receiving the initial dose of CD-JEV, eligible participants will be vaccinated with a second subcutaneous dose of CD-JEV to assess the antibody response.
Participants will be monitored for safety for 28 days following receipt of the booster dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live Attenuated JE SA-14-14-2 Vaccine (CD-JEV) | Experimental | Participants previously vaccinated with CD-JEV will receive a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine four years after initial vaccination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine | Biological | 0.5 mL subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV | Seroprotection rate is defined as the percentage of participants with an anti-Japanese encephalitis (JE) neutralizing antibody titer ≥ 1:10 as measured using a 50% plaque reduction neutralization test (PRNT-50). Seroprotection was assessed at 3 and 4 years after the initial vaccination in Study JEV05, prior to participants receiving a booster vaccination in the current study. | 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365) |
| Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV | The geometric mean titer (GMT) of anti-JE neutralizing antibodies 3 and 4 years after initial vaccination with CD-JEV in Study JEV05 and prior to receiving the booster vaccination in the current study, measured using PRNT-50. | 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365) |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection Rate 7 Days and 28 Days After Booster Dose | Seroprotection rate is defined as the percentage of study participants with an anti-JE neutralizing antibody titer ≥1:10 assessed using PRNT-50. | 7 days and 28 days following booster vaccination (Study Days 372 and 393) |
| GMT of Anti-JE Neutralizing Antibodies 7 Days and 28 Days After Booster Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K Zaman, PhD, MPH, MBBS | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25239483 | Result | Zaman K, Naser AM, Power M, Yaich M, Zhang L, Ginsburg AS, Luby SP, Rahman M, Hills S, Bhardwaj M, Flores J. Lot-to-lot consistency of live attenuated SA 14-14-2 Japanese encephalitis vaccine manufactured in a good manufacturing practice facility and non-inferiority with respect to an earlier product. Vaccine. 2014 Oct 21;32(46):6061-6. doi: 10.1016/j.vaccine.2014.09.012. Epub 2014 Sep 18. | |
| 35243320 |
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Children were analyzed based on whether they received vaccine from the new or old facility in Study JEV05:
This study enrolled Bangladeshi children who had participated in Study JEV05 (NCT01567865) and received a single dose of live attenuated Japanese encephalitis vaccine (CD-JEV).
The first visit in this study was 3 years after vaccination in JEV05. At the 2nd study visit, 4 years after initial vaccination, children received a booster dose of CD-JEV.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: CD-JEV | Participants previously vaccinated with CD-JEV manufactured in the new facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination. |
| FG001 | Group B: CD-JEV | Participants previously vaccinated with CD-JEV manufactured in the old facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: CD-JEV | Participants previously vaccinated with CD-JEV manufactured in the new facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination. |
| BG001 | Group B: CD-JEV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV | Seroprotection rate is defined as the percentage of participants with an anti-Japanese encephalitis (JE) neutralizing antibody titer ≥ 1:10 as measured using a 50% plaque reduction neutralization test (PRNT-50). Seroprotection was assessed at 3 and 4 years after the initial vaccination in Study JEV05, prior to participants receiving a booster vaccination in the current study. | Enrolled participants with at least one serology result at Year 3 (Day 1) or Year 4 (Day 365), prior to receiving the booster dose (long-term assessment intention-to-treat population [ITT]). | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365) |
|
28 days after booster vaccination (Study Day 365 to 393)
Adverse events are reported for all participants who received the CD-JEV booster vaccination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: CD-JEV | Participants previously vaccinated with CD-JEV manufactured in the new facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Flores, MD | PATH | (202) 822-0033 | jeflores@path.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2018 | Sep 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2018 | Sep 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| D018177 | Flavivirus Infections |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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Geometric mean titer of anti-JE neutralizing antibodies measured using PRNT-50. |
| 7 days and 28 days following booster vaccination (Study Days 372 and 393) |
| Seroconversion Rate 7 Days and 28 Days After Booster Dose | Seroconversion rate is defined as the percentage of study participants with either:
| 7 days and 28 days following booster vaccination (Study Days 372 and 393) |
| GMT Ratio of Anti-JE Neutralizing Antibody Titers Between Post-Booster and Pre-Booster Vaccination | To evaluate the magnitude of the increase in GMTs, the GMT ratio of anti-JE neutralizing antibody titers between post-booster vaccination and pre-booster vaccination was calculated for the following:
| 4 years after the initial vaccination (Study Day 365, pre-booster vaccination) and 7 and 28 days following booster vaccination (Study Days 372 and 393) |
| Number of Participants With Immediate Reactions 30 Minutes Following Booster Vaccination | The number of participants with at least one occurrence of an immediate reaction, including local, systemic, or unsolicited adverse event that occurred within 30 minutes of the booster vaccination. | 30 minutes following booster vaccination (Study Day 365) |
| Number of Participants With Solicited Local Reactions Occurring Within 7 Days of Booster Vaccination | Participants were monitored for local reactions from 30 minutes through 7 days post booster vaccination. Local reactions (at the injection site) included the following:
Local ecchymosis, erythema, edema, and induration were graded as follows:
Injection site pain/tenderness were graded as follows:
| From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372) |
| Number of Participants With Solicited Systemic Reactions Occurring Within 7 Days of Booster Vaccination | Participants were monitored for systemic reactions from 30 minutes through 7 days post booster vaccination. Systemic reactions (general signs / symptoms) included the following:
Fever was graded as follows:
Change in eating habits, diarrhea, sleepiness, irritability, unusual crying, vomiting were graded as follows:
| From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372) |
| Number of Participants With Unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) Within 28 Days Following Booster Vaccination | AEs were graded for severity according to the following: Grade 1 (Mild): Symptoms causing no or minimal interference with usual social and functional activities Grade 2 (Moderate): Symptoms causing greater than minimal interference with usual social and functional activities Grade 3 (Severe): Symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated Grade 4 (Potentially life-threatening): Symptoms causing inability to perform basic self-care functions OR medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Relationship to study vaccine was based on the Clinician's assessment. A serious adverse event is defined as an AE that meets 1 of the following criteria:
| 28 days following booster vaccination (Study Days 365 to 393) |
| Derived |
| Zaman K, Yunus M, Aziz AB, Feser J, Mooney J, Tang Y, Ellison DW, Thaisomboonsuk B, Zhang L, Neuzil KM, Marfin AA, Letson GW. Antibody persistence and immune memory response following primary vaccination and boosting with live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) in Bangladesh: A phase 4 open-label clinical trial. Vaccine X. 2022 Feb 5;10:100143. doi: 10.1016/j.jvacx.2022.100143. eCollection 2022 Apr. |
| Withdrawal by Subject |
|
| Other |
|
Participants previously vaccinated with CD-JEV manufactured in the old facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Group B: CD-JEV | Participants previously vaccinated with CD-JEV manufactured in the old facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination. |
| OG002 | Total | Participants previously vaccinated with CD-JEV received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination. |
|
|
|
| Primary | Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV | The geometric mean titer (GMT) of anti-JE neutralizing antibodies 3 and 4 years after initial vaccination with CD-JEV in Study JEV05 and prior to receiving the booster vaccination in the current study, measured using PRNT-50. | Enrolled participants with at least one serology result at Year 3 (Day 1) or Year 4 (Day 365), prior to receiving the booster dose. | Posted | Geometric Mean | 95% Confidence Interval | titer | 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365) |
|
|
|
|
| Secondary | Seroprotection Rate 7 Days and 28 Days After Booster Dose | Seroprotection rate is defined as the percentage of study participants with an anti-JE neutralizing antibody titer ≥1:10 assessed using PRNT-50. | Participants who received the booster dose of CD-JEV and had at least one serology result 7 days or 28 days after the booster vaccination (ITT booster analysis set). | Posted | Number | 95% Confidence Interval | percentage of participants | 7 days and 28 days following booster vaccination (Study Days 372 and 393) |
|
|
|
|
| Secondary | GMT of Anti-JE Neutralizing Antibodies 7 Days and 28 Days After Booster Dose | Geometric mean titer of anti-JE neutralizing antibodies measured using PRNT-50. | Participants who received the booster dose of CD-JEV and had at least one serology result 7 days or 28 days after the booster vaccination (ITT booster analysis set). | Posted | Geometric Mean | 95% Confidence Interval | titer | 7 days and 28 days following booster vaccination (Study Days 372 and 393) |
|
|
|
|
| Secondary | Seroconversion Rate 7 Days and 28 Days After Booster Dose | Seroconversion rate is defined as the percentage of study participants with either:
| Participants who received the booster dose of CD-JEV and had at least one serology result 7 days or 28 days after the booster vaccination (ITT booster analysis set). | Posted | Number | 95% Confidence Interval | percentage of participants | 7 days and 28 days following booster vaccination (Study Days 372 and 393) |
|
|
|
|
| Secondary | GMT Ratio of Anti-JE Neutralizing Antibody Titers Between Post-Booster and Pre-Booster Vaccination | To evaluate the magnitude of the increase in GMTs, the GMT ratio of anti-JE neutralizing antibody titers between post-booster vaccination and pre-booster vaccination was calculated for the following:
| Participants who received the booster dose of CD-JEV and had at least one serology result 7 days or 28 days after the booster vaccination (ITT booster analysis set). | Posted | Number | 95% Confidence Interval | ratio | 4 years after the initial vaccination (Study Day 365, pre-booster vaccination) and 7 and 28 days following booster vaccination (Study Days 372 and 393) |
|
|
|
| Secondary | Number of Participants With Immediate Reactions 30 Minutes Following Booster Vaccination | The number of participants with at least one occurrence of an immediate reaction, including local, systemic, or unsolicited adverse event that occurred within 30 minutes of the booster vaccination. | Participants who received the booster vaccination | Posted | Count of Participants | Participants | 30 minutes following booster vaccination (Study Day 365) |
|
|
|
| Secondary | Number of Participants With Solicited Local Reactions Occurring Within 7 Days of Booster Vaccination | Participants were monitored for local reactions from 30 minutes through 7 days post booster vaccination. Local reactions (at the injection site) included the following:
Local ecchymosis, erythema, edema, and induration were graded as follows:
Injection site pain/tenderness were graded as follows:
| Participants who received the booster vaccination | Posted | Count of Participants | Participants | From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372) |
|
|
|
| Secondary | Number of Participants With Solicited Systemic Reactions Occurring Within 7 Days of Booster Vaccination | Participants were monitored for systemic reactions from 30 minutes through 7 days post booster vaccination. Systemic reactions (general signs / symptoms) included the following:
Fever was graded as follows:
Change in eating habits, diarrhea, sleepiness, irritability, unusual crying, vomiting were graded as follows:
| Participants who received the booster vaccination | Posted | Count of Participants | Participants | From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372) |
|
|
|
| Secondary | Number of Participants With Unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) Within 28 Days Following Booster Vaccination | AEs were graded for severity according to the following: Grade 1 (Mild): Symptoms causing no or minimal interference with usual social and functional activities Grade 2 (Moderate): Symptoms causing greater than minimal interference with usual social and functional activities Grade 3 (Severe): Symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated Grade 4 (Potentially life-threatening): Symptoms causing inability to perform basic self-care functions OR medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Relationship to study vaccine was based on the Clinician's assessment. A serious adverse event is defined as an AE that meets 1 of the following criteria:
| Participants who received the booster vaccination | Posted | Count of Participants | Participants | 28 days following booster vaccination (Study Days 365 to 393) |
|
|
|
| 0 |
| 424 |
| 0 |
| 424 |
| 57 |
| 424 |
| EG001 | Group B: CD-JEV | Participants previously vaccinated with CD-JEV manufactured in the old facility received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination. | 0 | 109 | 0 | 109 | 26 | 109 |
| EG002 | Total | Participants previously vaccinated with CD-JEV received a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine by subcutaneous injection four years after initial vaccination. | 0 | 533 | 0 | 533 | 83 | 533 |
| Otorrhoea | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Measles | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Mumps | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Animal scratch | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Gastric pH decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
Not provided
Not provided
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| Year 4 |
|
|
| GMT Ratio (Group A/B) |
| 1.0 |
| 2-Sided |
| 95 |
| 0.9 |
| 1.1 |
| Other |
| 28 days after booster |
|
|
| Difference (Group A - B) |
| -1.3 |
| 2-Sided |
| 95 |
| -3.3 |
| 3.0 |
| Other |
| 28 days after booster |
|
|
| GMT Ratio (Group A/B) |
| 0.7 |
| 2-Sided |
| 95 |
| 0.6 |
| 0.9 |
| Other |
| 28 days after booster |
|
|
| Difference (Group A - B) |
| -1.8 |
| 2-Sided |
| 95 |
| -4.4 |
| 3.0 |
| Other |
| 28 days after booster |
|
|
|
| Injection site swelling |
|
| Title | Measurements |
|---|---|
|
| Erythema |
|
| Edema |
|
| Induration |
|
| Pain/tenderness |
|
| Pain/tenderness - Grade 1 |
|
| Title | Measurements |
|---|---|
|
| Fever - Grade 1 |
|
| Fever - Grade 2 |
|
| Change in eating habits |
|
| Change in eating habits - Grade 1 |
|
| Diarrhea |
|
| Sleepiness |
|
| Irritability |
|
| Irritability - Grade 1 |
|
| Unusual crying |
|
| Vomiting |
|
| Vomiting - Grade 1 |
|
|
| Moderate adverse events |
|
| Severe adverse events |
|
| Life-threatening adverse events |
|
| Related adverse events |
|
| Unrelated adverse events |
|
| Serious adverse events |
|