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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1112-2269 | Other Identifier | WHO |
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The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric virus vaccine (JE-CV) with a single dose of SA14-14-2 live vaccine as primary vaccination in infants and toddlers.
Primary Objective:
Secondary Objectives:
All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JE-CV Group | Experimental | Participants will receive one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) |
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| SA14-14-2 vaccine Group | Active Comparator | Participants will receive one dose of Japanese encephalitis live vaccine, SA14-14-2 vaccine. (CD.JEVAX®) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Japanese encephalitis chimeric virus vaccine (JE-CV) | Biological | 0.5 mL, Subcutaneous |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50). Japanese Encephalitis seroconversion was defined as a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination. | Day 0 through Day 28 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12. |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | 10330 | Thailand | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24717964 | Derived | Feroldi E, Pancharoen C, Kosalaraksa P, Chokephaibulkit K, Boaz M, Meric C, Hutagalung Y, Bouckenooghe A. Primary immunization of infants and toddlers in Thailand with Japanese encephalitis chimeric virus vaccine in comparison with SA14-14-2: a randomized study of immunogenicity and safety. Pediatr Infect Dis J. 2014 Jun;33(6):643-9. doi: 10.1097/INF.0000000000000276. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled; 299 were vaccinated.
Participants were enrolled from 07 March 2010 to 27 April 2011 at 3 clinical centers in Thailand.
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| ID | Title | Description |
|---|---|---|
| FG000 | Japanese Encephalitis Chimeric Vaccine (JE-CV) | Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0. |
| FG001 | Japanese Encephalitis Live Vaccine (SA14-14-2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®) |
| Biological |
0.5 mL, Subcutaneous |
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| Day 28 post-vaccination |
| Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Seroconversion was defined as a pre-vaccination titer < 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination. | Day 28 post-vaccination |
| Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. | Day 0 (pre-vaccination) and Day 28 post-vaccination |
| Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12. | Day 28 up to 12 months post-vaccination |
| Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. | Day 0 (pre-vaccination) and up to 12 months post-vaccination |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability. Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature > 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable. | Day 0 through Day 14 post-vaccination |
| Bangkok |
| 10700 |
| Thailand |
| Khon Kaen | 40002 | Thailand |
Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Japanese Encephalitis Chimeric Vaccine (JE-CV) | Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0. |
| BG001 | Japanese Encephalitis Live Vaccine (SA14-14-2) | Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| 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 of Participants With Japanese Encephalitis Seroconversion After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | Immunogenicity was assessed by the JE-CV virus and the SA14-14-2 virus 50% plaque reduction neutralization test (PRNT50). Japanese Encephalitis seroconversion was defined as a pre-vaccination titer <10 1/dil and post-vaccination titer ≥ 10 1/dil; or a pre-vaccination titer ≥ 10 1/dil and a 4-fold increase from pre- to post-vaccination. | Japanese encephalitis antibody titers were assessed in all participants with immunogenicity data and who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population) | Posted | Number | Participants | Day 0 through Day 28 after vaccination |
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| Secondary | Number of Participants With Japanese Encephalitis Seroprotection 28 Days After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12. | Japanese encephalitis antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population) | Posted | Number | Participants | Day 28 post-vaccination |
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| Secondary | Number of Participants With Seroconversion After Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2) (CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Seroconversion was defined as a pre-vaccination titer < 10 1/dil and post vaccination titer ≥ 10 1/dil, or a pre-vaccination titer ≥ 10 and a 4-fold increase from pre- to post-vaccination. | Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population) | Posted | Number | Participants | Day 28 post-vaccination |
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| Secondary | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. | Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per-Protocol Population) | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) and Day 28 post-vaccination |
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| Secondary | Summary of Participants With Japanese Encephalitis Seroprotection After Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2, CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. Japanese encephalitis seroprotection defined as participant with antibody titer ≥ 1:10 at baseline (D0) and on Day 28, Month 6, and Month 12. | Japanese encephalitis antibody titers were assessed in all vaccinated participants with available immunogenicity data (Full Analysis Set) | Posted | Number | Participants | Day 28 up to 12 months post-vaccination |
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| Secondary | Summary of Geometric Mean Titers of Vaccine Antibodies Before and Following One Dose of Vaccination With Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2; CD.JEVAX®) | Immunogenicity was assessed by JE-CV virus 50% plaque reduction neutralization test (PRNT50) or SA14-14-2 virus PRNT50. | Japanese encephalitis antibody titers were assessed in all participants that received a vaccine and with available immunogenicity data (Full Analysis Set) | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) and up to 12 months post-vaccination |
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| Secondary | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Japanese Encephalitis Live Vaccine (SA14-14-2 Vaccine) (CD.JEVAX®) | Solicited Injection Site Reactions: Tenderness, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability. Grade 3 Reactions defined as: Tenderness - crying when injected limb was moved, or movement of the injected limb was reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature > 39.5ºC; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite loss - refused ≥ 3 feeds or refused most feeds; and Irritability - inconsolable. | Solicited injection site and systemic reactions were assessed in all participants who received a study vaccination and for whom safety data were available, according to the vaccine actually received (Safety Population). | Posted | Number | Participants | Day 0 through Day 14 post-vaccination |
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Adverse events were assessed from Day 0 (post-vaccination) through 12 months post-vaccination.
Two participants randomized to receive JE-CV received SA14-14-2 vaccine instead. They were analyzed in the Full Analysis Set according to the group to which they were randomized (JE-CV) and in the Safety Analysis Set according to the vaccine actually received (SA14-14-2 vaccine)
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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 | Japanese Encephalitis Chimeric Vaccine (JE-CV) | Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0. | 14 | 147 | 66 | 147 | ||
| EG001 | Japanese Encephalitis Live Vaccine (SA14-14-2) | Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0. | 18 | 152 | 88 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophageal Obstruction | Gastrointestinal disorders | MedRA 12.0 | Non-systematic Assessment |
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| Anal Abscess | Infections and infestations | MedRA 12.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Dengue Fever | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Diarrhoea Infectious | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis Rotavirus | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis Viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Pneumonia Bacterial | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Pneumonia Respiratory Syncytial Viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Febrile Convulsion | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Balanitis | Reproductive system and breast disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA12.0 | Systematic Assessment |
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| Crying Abnormal | General disorders | MedDRA12.0 | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA12.0 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA12.0 | Systematic Assessment |
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| Injection Site Tenderness | General disorders | MedDRA12.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA12.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA12.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA12.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA12.0 | Non-systematic Assessment |
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| Appetite Loss | Metabolism and nutrition disorders | MedDRA12.0 | Systematic Assessment |
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| Drowsiness | Nervous system disorders | MedDRA12.0 | Systematic Assessment |
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| Fever | General disorders | MedDRA 12.0 | Systematic Assessment |
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Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D004660 | Encephalitis |
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| 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 |
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| >=65 years |
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| Male |
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| Participants |
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