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The purpose of this study is to obtain safety, tolerability, and immunogenicity data on the co-administration or sequential administration of Chimeravax™-JE vaccine and STAMARIL®.
Objectives:
Safety:
Immunogenicity:
All participants will receive two injections, one to each arm on Days 0 and 30, respectively. Immunogenicity will be tested on Days 0, 15, 30, 45, and 60, and at Month 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChimeriVax™-JE then STAMARIL® | Experimental | Participants will receive ChimeriVax™-JE on Day 0 and STAMARIL® on Day 30 |
|
| STAMARIL® then ChimeriVax™-JE | Experimental | Participants will receive STAMARIL® on Day 0 and ChimeriVax™-JE on Day 30 |
|
| ChimeriVax™-JE and STAMARIL®, then Diluent | Experimental | Participants will receive ChimeriVax™-JE and STAMARIL® on Day 0 and diluent on Day 30. |
|
| Diluent then ChimeriVax™-JE and STAMARIL® | Experimental | Participants will receive Diluent on Day 0 and ChimeriVax™-JE and STAMARIL® on Day 30. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live attenuated Japanese encephalitis virus; Yellow fever virus | Biological | ChimeriVax™-JE, 0.5 mL, Subcutaneous on Day 0; STAMARIL®, 0.5 mL, Subcutaneous on Day 30. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Japanese Encephalitis Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. | Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples. The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL). | Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60) |
| Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination. | Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples. The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL). | Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60) |
| Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. | Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL) |
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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 |
|---|---|---|---|---|---|---|
| Herston | Queensland | QLD 4006 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20864814 | Result | Nasveld PE, Marjason J, Bennett S, Aaskov J, Elliott S, McCarthy K, Kanesa-Thasan N, Feroldi E, Reid M. Concomitant or sequential administration of live attenuated Japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine: randomized double-blind phase II evaluation of safety and immunogenicity. Hum Vaccin. 2010 Nov;6(11):906-14. doi: 10.4161/hv.6.11.12854. Epub 2010 Nov 1. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 108 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants were screened and enrolled from 27 July 2004 to 27 September 2004 at 1 clinical center in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | ChimeriVax™-JE Then STAMARIL® | All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30. |
| FG001 | STAMARIL® Then ChimeriVax™-JE |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Yellow fever virus; Live attenuated Japanese encephalitis virus | Biological | STAMARIL®, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous on Day 30. |
|
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| Live attenuated Japanese encephalitis virus; Yellow fever virus | Biological | ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL, Subcutaneous on Day 0; Diluent 0.5 mL, Subcutaneous on Day 30. |
|
|
| Live attenuated Japanese encephalitis virus; Yellow fever virus | Biological | Diluent, 0.5 mL Subcutaneous on Day 0; ChimeriVax™-JE, 0.5 mL Subcutaneous and STAMARIL®, 0.5 mL Subcutaneous on Day 30. |
|
|
| Day 0 (Pre-vaccination) through Day 30 post-vaccination |
| Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo | Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain. All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups. | Day 0 up to Day 60 post-vaccination |
| Day 0 through 6 months post-vaccination |
| Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo | Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test. Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL). | Day 0 through 6 months post-vaccination |
All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
| FG002 | Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent | All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. |
| FG003 | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ChimeriVax™-JE Then STAMARIL® | All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30. |
| BG001 | STAMARIL® Then ChimeriVax™-JE | All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30. |
| BG002 | Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent | All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. |
| BG003 | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
|
| 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 Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. | Neutralising antibody titer against homologous Japanese encephalitis (JE), yellow fever (YF), and other relevant wild type JE strains were determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion post-vaccination was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-vaccination (Day 0) and the post-vaccination samples. The 30 Days post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL). | Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population). | Posted | Number | Participants | Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60) |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Yellow Fever Seroconversion Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL® or Placebo Vaccination. | Neutralising antibody titer against yellow fever strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint ws defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titre between the pre-injection Day 0 and later post vaccination samples. The Day 30 post-JE seroconversion is: Day 30 for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 60 for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL). | Yellow fever seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population). | Posted | Number | Participants | Pre-vaccination (Day 0 or 30) and post-vaccination (Day 30 or 60) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) to Japanese Encephalitis (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo Vaccination. | Neutralising antibody titer against homologous Japanese encephalitis (JE) and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Post-vaccination 15 (30) Days JE seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL) | GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-protocol Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 through 6 months post-vaccination |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers to Yellow Fever (Homologous Virus) Following ChimeriVax™-JE or STAMARIL® Alone or the Co-administration of ChimeriVax™-JE and STAMARIL®, or Placebo | Neutralising antibody titer against homologous yellow fever was determined using a 50% serum dilution plaque reduction neutralisation test. Post vaccination 15 (30) Days Yellow Fever seroconversion is: Day 15 (30) for Group 1 (ChimeriVax™-JE then STAMARIL®) and Group 3 (Co-administration of ChimeriVax™-JE and STAMARIL, then Diluent); Day 45 (60) for Group 2 (STAMARIL® then ChimeriVax™-JE) and Group 4 (Diluent then Co-administration of ChimeriVax™-JE and STAMARIL). | GMTs were assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per-Protocol Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 through 6 months post-vaccination |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Seroconverted to Japanese Encephalitis 30 Days Post ChimeriVax™-JE Vaccination | Neutralising antibody titer against homologous JE, YF, and other relevant wild type JE strains was determined using a 50% serum dilution plaque reduction neutralisation test. Seroconversion at a later post vaccination timepoint was defined as the appearance of neutralising antibody titer when not present at Day 0, or at least a four-fold rise in neutralising antibody titer between the pre-injection Day 0 and post-vaccination samples. | Japanese encephalitis seroconversion was assessed in all participants who were flavivirus naive at Day 0 and who had no protocol violations that might have interfered with analysis of primary endpoints (Per Protocol Population). | Posted | Number | Participants | Day 0 (Pre-vaccination) through Day 30 post-vaccination |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Solicited Local and Systemic Adverse Events Post Vaccination With ChimeriVax™-JE or STAMARIL® Alone or the Co-Administration of ChimeriVax™-JE and STAMARIL®, or Placebo | Solicited Local Adverse Events: Injection Site Pain, Erythema, Swelling, Hemorrhage, Venipuncture site Hemorrhage. Solicited Systemic Adverse Events: Fatigue, Malaise, Pyrexia, Chills, Headache, Dizziness, Myalgia, Abdominal Pain, Diarrhea, Nausea, Pharyngolaryngeal Pain. All solicited local reactions associated with ChimeriVax™-JE are presented in Group 1, those associated with STAMARIL® in Group 2, those associated with co-administered vaccines in Group 3, and those associated with diluent in Group 4. The solicited systemic adverse events are reported according to the participants' randomized study groups. | Safety analyses were performed on data from all randomized subjects who received at least one dose of study medication: ChimeriVax JE, STAMARIL, or Diluent (Safety Population). | Posted | Number | Participants | Day 0 up to Day 60 post-vaccination |
|
Adverse events data were collected from Day 0, after vaccination up to Month 6 post-vaccination.
Solicited local reactions associated with ChimeriVax™-JE are presented in Group 1; associated with STAMARIL® in Group 2; associated co-administered vaccines in Group 3, and associated with diluents in Group 4. Solicited systemic reactions and unsolicited adverse events are reported according to the participants' randomized study groups.
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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 | ChimeriVax™-JE Then STAMARIL® | All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30. | 0 | 36 | 18 | 71 | ||
| EG001 | STAMARIL® Then ChimeriVax™-JE | All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30. | 0 | 36 | 20 | 72 | ||
| EG002 | Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent | All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. | 0 | 18 | 6 | 36 | ||
| EG003 | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. | 0 | 18 | 10 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Systematic Assessment |
|
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 |
|---|---|
| D004672 | Encephalitis, Japanese |
| D015004 | Yellow Fever |
| ID | Term |
|---|---|
| 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 |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D006482 | Hemorrhagic Fevers, Viral |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Day 60 (N = 17, 23, 13, 10) |
|
| 30 Days Post-JE Seroconversion (N = 17, 23, 23, 0) |
|
| OG002 | Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent | Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30. |
| OG003 | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30. |
|
|
| Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent |
All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. |
| OG003 | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. |
|
|
All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. |
| OG003 | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. |
|
|
Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
| OG003 | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30. |
|
|
| OG002 | Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent | All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30. |
| OG003 | Diluent Then Coadministration With ChimeriVax-JE and STAMARIL® | All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30. |
|
|