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The proposed study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Lot | Active Comparator | Lot of Vaccine produced in existing facility |
|
| New Lot #1 | Experimental | First lot of vaccine produced in new facility |
|
| New Lot #2 | Experimental | Second lot of vaccine produced in new facility |
|
| New Lot #3 | Experimental | Third lot of vaccine produced in new facility |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine produced in existing facility | Biological | Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| Measure | Description | Time Frame |
|---|---|---|
| Number/Percentage of Subjects With Demonstrated Seroprotection | Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control. In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT [Hombach et al. 2005]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study. | 28 days post-vaccination |
| Geometric Mean Titers (GMT) | Geometric Mean Titers of Neutralizing anti-JEV antibody | 28 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE) | Subjects were monitored for the following adverse events and categorized as events almost certainly related to receipt of the vaccine: Redness Swelling Tenderness Dyspnea Cyanosis Loose Stools Vomiting Convulsion Fever (37 degrees Celsius or greater, axillary) Hives (urticaria) Angioedema | Within 30 minutes of vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K Zaman, MD | ICCDR,B | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICDDR,B | Dhaka | Bangladesh |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference Lot | Lot of Vaccine produced in existing facility Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| FG001 | New Lot #1 | First lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| FG002 | New Lot #2 | Second lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| FG003 | New Lot #3 | Third lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrolled and Vaccinated (Day 0) |
| |||||||||||||
| Evaluated for Immunogenicity |
|
Per-protocol population
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| ID | Title | Description |
|---|---|---|
| BG000 | Reference Lot | Lot of Vaccine produced in existing facility Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| BG001 | New Lot #1 |
| 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 | Number/Percentage of Subjects With Demonstrated Seroprotection | Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control. In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT [Hombach et al. 2005]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study. | Per protocol population | Posted | Count of Participants | Participants | 28 days post-vaccination |
|
28 days post-vaccination
Adverse events other than solicited reactogenicities within the time frame. If the parent/guardian failed to come on day 28, a maximum of 4 days was allowed for follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference Lot | Lot of Vaccine produced in existing facility Vaccine produced in existing facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
Lower than anticipated rates of enrollment across all groups made it necessary to analyze antibody response data in smaller samples than initially planned. This adversely influenced the precision of all estimates (i.e., resulted in broader 95% CIs)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Flores | PATH | (202) 822-0033 | jeflores@path.org |
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| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| Vaccine produced in new facility | Biological | Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
|
| Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination | Collected by a home visit to observe the subject and interview his/her parent or guardian occurrence and severity of solicited injection site reactogenicity events (REs) related to vaccination and solicited systemic REs or other AEs that might or might not be related to the prior receipt of vaccine | Within 7 days of vaccination |
| Number/Percentage of Subjects With Other Adverse Events (AE) During the Study | Adverse events other than solicited reactogenicities were obtained through review of medical history when subject returned to clinic. They were graded for severity and rated by the PI for possible relationship to vaccination throughout the 28 days study period. | Between 7 and 28 days of vaccination |
| COMPLETED |
|
| NOT COMPLETED |
|
|
First lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| BG002 | New Lot #2 | Second lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| BG003 | New Lot #3 | Third lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| BG004 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | New Lot #1 | First lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| OG002 | New Lot #2 | Second lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| OG003 | New Lot #3 | Third lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China |
| OG004 | All New Lots | All subjects receiving vaccine from the new facility (Lot 1, 2, or 3) |
|
|
|
| Primary | Geometric Mean Titers (GMT) | Geometric Mean Titers of Neutralizing anti-JEV antibody | Per-Protocol Population | Posted | Geometric Mean | 95% Confidence Interval | titer | 28 days post-vaccination |
|
|
|
| Secondary | Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE) | Subjects were monitored for the following adverse events and categorized as events almost certainly related to receipt of the vaccine: Redness Swelling Tenderness Dyspnea Cyanosis Loose Stools Vomiting Convulsion Fever (37 degrees Celsius or greater, axillary) Hives (urticaria) Angioedema | All study subjects receiving vaccine were included in this measure. | Posted | Count of Participants | Participants | Within 30 minutes of vaccination |
|
|
|
| Secondary | Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination | Collected by a home visit to observe the subject and interview his/her parent or guardian occurrence and severity of solicited injection site reactogenicity events (REs) related to vaccination and solicited systemic REs or other AEs that might or might not be related to the prior receipt of vaccine | All subjects receiving the vaccine were assessed for this measure. | Posted | Count of Participants | Participants | Within 7 days of vaccination |
|
|
|
| Secondary | Number/Percentage of Subjects With Other Adverse Events (AE) During the Study | Adverse events other than solicited reactogenicities were obtained through review of medical history when subject returned to clinic. They were graded for severity and rated by the PI for possible relationship to vaccination throughout the 28 days study period. | All subjects receiving the vaccine were evaluated for this measure. | Posted | Count of Participants | Participants | Between 7 and 28 days of vaccination |
|
|
|
| 0 |
| 163 |
| 2 |
| 163 |
| 60 |
| 163 |
| EG001 | New Lot #1 | First lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China | 0 | 220 | 4 | 220 | 84 | 220 |
| EG002 | New Lot #2 | Second lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China | 0 | 211 | 4 | 211 | 92 | 211 |
| EG003 | New Lot #3 | Third lot of vaccine produced in new facility Vaccine produced in new facility: Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China | 0 | 224 | 0 | 224 | 77 | 224 |
| Dysentery | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute watery diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Mucous stools | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site erythema | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Irritability | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Swelling | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Crying | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinorhhea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Furuncle | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritis generalized | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| No immediate RE |
|
| No RE |
|
| No AE |
|