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| ID | Type | Description | Link |
|---|---|---|---|
| GSK 103996 | Other Identifier | GalaxoSmithKline | |
| HSRRB A-13291 | Other Identifier | USAMRMC HSRRB |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Walter Reed Army Institute of Research (WRAIR) | FED |
This descriptive study will evaluate the safety and immunogenicity of 3 different formulations of the WRAIR dengue vaccine compared to a placebo.
Subjects will be randomized into one of 4 groups. One group will receive a placebo vaccine and the others will receive one of 3 different dengue vaccine formations. Each subject will receive two doses six months apart. Study subjects who elect to participate in a mosquito transmissibility component of the study will undergo mosquito feedings during each of the two assigned follow-up visits after vaccine dose 1. All subjects will have 11 venipunctures during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.
A third (booster) dose of post transfection F17 or F19 will be administered approximately 5 to 12 months after dose 2 to all subjects who received one of these formulation for their first two doses. Volunteers will return for a single visit 6 months after receiving their booster dose (long term follow-up)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-transfection F17 | Experimental | 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine |
|
| Post-transfection F17 | Experimental | 4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection |
|
| Post-transfection F19 | Experimental | 4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection |
|
| Placebo | Placebo Comparator | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-transfection F17 | Biological | Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 | GMTs for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1 | Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3 |
| Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 | Serpositivity rates for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1 | Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3 |
| Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine | Diary cards, digital thermometers, and small rulers were provided to subjects to record local and general solicited symptoms(pain, redness and swelling at the injection site, fatigue, headache, pain behind the eyes, abdominal pain, nausea, vomiting, muscle aches, joint aches, rash, photophobia and pruritis) and oral temperature taken daily for 21 days (days 0 through 20). The observations were to be recorded each evening and account for the previous 24 hours. If multiple temperature measurements were taken throughout the day, the maximum temperature was to be recorded. | 21 days following 1st vaccination dose |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine; | within 21 days after vaccination | |
| Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose | Summary of Unsolicited Adverse Events within 31 days after each dose of study vaccine dose (Primary total vaccinated cohort) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Thomas, MD, FACP | Walter Reed Army Institute of Research (WRAIR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Institute of Research | Silver Spring | Maryland | 20910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23208878 | Derived | Thomas SJ, Eckels KH, Carletti I, De La Barrera R, Dessy F, Fernandez S, Putnak R, Toussaint JF, Sun W, Bauer K, Gibbons RV, Innis BL. A phase II, randomized, safety and immunogenicity study of a re-derived, live-attenuated dengue virus vaccine in healthy adults. Am J Trop Med Hyg. 2013 Jan;88(1):73-88. doi: 10.4269/ajtmh.2012.12-0361. Epub 2012 Dec 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-transfection F17 | 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Post-transfection F17 | Biological | Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
|
| Post-transfection F19 | Biological | Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
|
| Placebo | Other | Sterile solution of buffered water (0.9% NaCl), U.S. FDA accepted vaccine excipient, phenol red dye(phenolsulfonphthalein, used in vaccines as a pH indicator); 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection |
|
| within 31 days of study vaccine |
| Occurrence of Serious Adverse Events (SAEs) Throughout the Entire Study Period. | Serious adverse events will be recorded throughout the entire study period. Subjects instructed to contact the investigator immediately should they manifest any signs or symptoms they perceive as serious. An identification card and a set of phone numbers to contact study staff 24 hours a day, 7 days a week given to subjects. | Days 0 to 270 |
| Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose | Abnormal findings at DEN physical examination were defined as: rash, generalized rash, hemorrhages (skin, conjunctival or mucosal), conjunctival injection, hepatomegaly, splenomegaly or lymphadenopathy; generalized lymphadenopathy (palpable lymph nodes in 4 or more of the following locations: cervical, axillary, inguinal or other with right and left sides considered as separate locations) positive tourniquet test (WHO criterion of 20 or more petechiae per 2.5 cm square)Results were reported positive/negative using the WHO criterion. | throughout the 202 day study |
| Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort) | The case definition of confirmed dengue used in this protocol requires fever (equivalent to an oral temperature ≥38.0ºC/≥ 100.4ºF) for three or more successive days, at least two of the signs or symptoms consistent with "suspected dengue" occurring during the period of fever, at least one clinical laboratory abnormality, and DEN viremia detected by RTqPCR. Cases not meeting all criteria were not considered "confirmed dengue." The percentage of subjects with suspected or confirmed dengue were tabulated by group after each vaccination. | Days 0-30 post vaccination periods (total vaccinated cohort) |
| Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose | Sero-response defined as: For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer | Days 0 to 270 |
| Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) | Sero-response defined as: For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer | Days 0 to 270 |
| Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. | For vireimia: Negative = GEQ/µl result is equal to zero Undetermined = GEQ/µL result is below LOD Positive = GEQ/µL result is >= LOD | Days 0 to 270 |
| FG001 | Post-transfection F17 | DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection. Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| FG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| FG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-transfection F17 | 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine. Pre-transfection F17: Dengue tetravalent Vaccine F17 Pre transfection: 1.0 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
| BG001 | Post-transfection F17 | DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lot 1262. Lyophilized, single dose vials and sterile water for injection. Post-transfection F17: Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| BG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| BG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
| 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 |
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| Age, Continuous | Mean | Standard Deviation | years |
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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 | N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 | GMTs for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1 | Number of subjects with titer within specified range | Posted | Mean | 95% Confidence Interval | GMT value | Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3 |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4 | Serpositivity rates for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1 | Vaccinated subjects for whom assay results were available. | Posted | Number | 95% Confidence Interval | percentage of participants | Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3 |
| |||||||||||||||||||||||||||||||||
| Primary | Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine | Diary cards, digital thermometers, and small rulers were provided to subjects to record local and general solicited symptoms(pain, redness and swelling at the injection site, fatigue, headache, pain behind the eyes, abdominal pain, nausea, vomiting, muscle aches, joint aches, rash, photophobia and pruritis) and oral temperature taken daily for 21 days (days 0 through 20). The observations were to be recorded each evening and account for the previous 24 hours. If multiple temperature measurements were taken throughout the day, the maximum temperature was to be recorded. | Posted | Number | participants | 21 days following 1st vaccination dose |
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| Secondary | Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine; | Subjects with sufficient data to perform safety analysis | Posted | Number | participants | within 21 days after vaccination |
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| Secondary | Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose | Summary of Unsolicited Adverse Events within 31 days after each dose of study vaccine dose (Primary total vaccinated cohort) | Posted | Number | Number of AEs | within 31 days of study vaccine |
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| Secondary | Occurrence of Serious Adverse Events (SAEs) Throughout the Entire Study Period. | Serious adverse events will be recorded throughout the entire study period. Subjects instructed to contact the investigator immediately should they manifest any signs or symptoms they perceive as serious. An identification card and a set of phone numbers to contact study staff 24 hours a day, 7 days a week given to subjects. | Posted | Number | participants | Days 0 to 270 |
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| Secondary | Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose | Abnormal findings at DEN physical examination were defined as: rash, generalized rash, hemorrhages (skin, conjunctival or mucosal), conjunctival injection, hepatomegaly, splenomegaly or lymphadenopathy; generalized lymphadenopathy (palpable lymph nodes in 4 or more of the following locations: cervical, axillary, inguinal or other with right and left sides considered as separate locations) positive tourniquet test (WHO criterion of 20 or more petechiae per 2.5 cm square)Results were reported positive/negative using the WHO criterion. | Posted | Number | participants | throughout the 202 day study |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort) | The case definition of confirmed dengue used in this protocol requires fever (equivalent to an oral temperature ≥38.0ºC/≥ 100.4ºF) for three or more successive days, at least two of the signs or symptoms consistent with "suspected dengue" occurring during the period of fever, at least one clinical laboratory abnormality, and DEN viremia detected by RTqPCR. Cases not meeting all criteria were not considered "confirmed dengue." The percentage of subjects with suspected or confirmed dengue were tabulated by group after each vaccination. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 0-30 post vaccination periods (total vaccinated cohort) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose | Sero-response defined as: For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer | Vaccinated subjects for whom assay results were available. | Posted | Number | 95% Confidence Interval | percentage of responders | Days 0 to 270 |
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| Secondary | Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued) | Sero-response defined as: For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer | Vaccinated subjects for whom assay results were available. | Posted | Number | 95% Confidence Interval | percentage of responders | Days 0 to 270 |
| |||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose. | For vireimia: Negative = GEQ/µl result is equal to zero Undetermined = GEQ/µL result is below LOD Positive = GEQ/µL result is >= LOD | Posted | Number | participants | Days 0 to 270 |
|
Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).
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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 | Pre-transfection F17 | 4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine | 0 | 22 | 0 | 22 | 19 | 22 |
| EG001 | Post-transfection F17 | monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection | 0 | 22 | 2 | 22 | 19 | 22 |
| EG002 | Post-transfection F19 | 4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection; 0.5 mL F19 vaccines | 0 | 21 | 1 | 21 | 16 | 21 |
| EG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. 0.5 mL for placebo | 0 | 21 | 1 | 21 | 13 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| axonal demyelinating polyneuropathy/bilateral upper and lower extremeties | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rule out cerebral bleed secondary to assualt trauma (physical assault) | Social circumstances | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Redness | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Swelling | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fever >37.5ºC | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Muscle aches | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain behind the eyes | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tooth ache | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vessel puncture site hemorrage | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fungal rash | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nerve injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ejaculation failure | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin warm | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Physical assault | Social circumstances | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Phlebotomy | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Division of Regulated Activities and Compliance Director | United States Army Medical Materiel Development Activity | 301-619-0317 | USAMRMCREGULATORYAFFAIRS@amedd.army.mil |
| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| DEN-1: PI(M1) |
|
|
| DEN-1: PII(M7) |
|
|
| DEN-1: PRE III |
|
|
| DEN-1: PIII(M1) |
|
|
| DEN-2: PRE |
|
|
| DEN-2: P1(M1) |
|
|
| DEN-2: PII(M7) |
|
|
| DEN-2: PRE III |
|
|
| DEN-2: PIII(M1) |
|
|
| DEN-3: PRE |
|
|
| DEN-3: PI(M1) |
|
|
| DEN-3: PII(M7) |
|
|
| DEN-3: PRE III |
|
|
| DEN-3: PIII(M1) |
|
|
| DEN-4: PRE |
|
|
| DEN-4: PI(M1) |
|
|
| DEN-4: PII(M7) |
|
|
| DEN-4: PRE III |
|
|
| DEN-4: PIII(M1) |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| OG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| OG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| OG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| OG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| OG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| OG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| OG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| OG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
|
|
| OG002 | Post-transfection F19 | DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Tetravalent vaccine lot 1263. Lyophilized, single dose vials and sterile water for injection Post-transfection F19: Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose. |
| OG003 | Placebo | A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Lot 1249. Lyophilized, single dose vials and sterile water for injection. Placebo: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. |
|
|