| ID | Type | Description | Link |
|---|---|---|---|
| GSK 103795 | Other Identifier | GSK | |
| WRAIR 1159 | Other Identifier | WRAIR |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered approx. 1 year following the second dose
The purpose of this study is to find out more about the two doses of dengue vaccine, over a five year period, that the children received in the Dengue-003 study and to study a third dose of dengue that will be given to the children
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total vaccinated | Experimental | The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEN vaccine F17 | Biological | The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points. | Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 |
| Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers [GMTs]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points. | Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited Local Adverse Events (AEs) Within 21 Day Follow-up | Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort). | 21 days |
| Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sriluck Simasathien, M.D. | Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand | Principal Investigator |
| Robert Gibbons, M.D. | Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Phramongkutklao Hospital | Phayathai | Bangkok | 10400 | Thailand |
GSK
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Seven Thai children from the Dengue-03 study will be invited to participate
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Vaccinated | The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003 DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Vaccinated | The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003 DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points. | Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1 | Posted | Mean | 95% Confidence Interval | % of subjects | Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 |
|
21 days post vaccination period following each dose
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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 | Total Vaccinated | The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003 DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sriluck Simasathien, MD | Dept of Pediatrics, Pharmongkutklao Hospital, Bankok, Thailand | 66-2-644-8971 | ssriluck@yahoo.com |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
|
Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)
| 31 days |
| Serious Adverse Events (SAE) Within 31 Days Post Vaccination | Occurrence of SAEs within 31 days (Day 0-30) after vaccination | 31 days |
| Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination | Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort) | 31 days |
| Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity) | Prebooster year 1, 30 Days Post Booster, Year 2, Year 3 |
| Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose | Nested Polymerase Chain Reaction (PCR) for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination | 10 days |
| Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | The ratio of DEN Immunoglobulin type M and G (IgM:IgG) measured at the time of booster vaccination and 30 days following was used to assess intercurrent flavivirus infection. Flavivirus infection in terms of dengue IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG is summarized. Flavivirus immunity= ratio IgM on IgG <1.8 with either IgM or IgM >1:40 If the antibody response is detectable by isotype capture enzyme immunoassay (either the IgM or IgG component ≥40 U), its anamnestic character can be inferred from detection of a DEN IgM to IgG ratio of <1.8. | 1 year, 30 Days Post Booster, 2 years |
| Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Clinical safety laboratory test were monitored for alert levels. Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Normal Ranges: Alanine Aminotransferases (ALT): LNL=0 and UNL=30 Aspartate Aminotransferases (AST): LNL=0 and UNL=40 Platelet (PLA): LNL=150000 and UNL=350000 Hematocrit (HC): LNL=35 and UNL=45 Neutrophil (NEU): LNL=1500 and UNL=8000 | Year 1 (day 0); Year 1 (day 30); Year 2 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers [GMTs]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points. | Posted | Mean | 95% Confidence Interval | GMTs | Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 |
|
|
|
| Secondary | Solicited Local Adverse Events (AEs) Within 21 Day Follow-up | Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort). | Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort). | Posted | Number | Adverse events | 21 days |
|
|
|
| Secondary | Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination | Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort) | Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort) | Posted | Number | 95% Confidence Interval | Percentage of subjects | 31 days |
|
|
|
| Secondary | Serious Adverse Events (SAE) Within 31 Days Post Vaccination | Occurrence of SAEs within 31 days (Day 0-30) after vaccination | Occurrence of SAEs within 31 days (Day 0-30) after vaccination | Posted | Count of Participants | Participants | 31 days |
|
|
|
| Secondary | Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination | Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort) | Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort) | Posted | Number | 95% Confidence Interval | Percentage of subjects | 31 days |
|
|
|
| Secondary | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity) | Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity). Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1 | Posted | Number | 95% Confidence Interval | percentage of subjects | Prebooster year 1, 30 Days Post Booster, Year 2, Year 3 |
|
|
|
| Secondary | Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose | Nested Polymerase Chain Reaction (PCR) for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination | Nested PCR for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination | Posted | Count of Participants | Participants | 10 days |
|
|
|
| Secondary | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | The ratio of DEN Immunoglobulin type M and G (IgM:IgG) measured at the time of booster vaccination and 30 days following was used to assess intercurrent flavivirus infection. Flavivirus infection in terms of dengue IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG is summarized. Flavivirus immunity= ratio IgM on IgG <1.8 with either IgM or IgM >1:40 If the antibody response is detectable by isotype capture enzyme immunoassay (either the IgM or IgG component ≥40 U), its anamnestic character can be inferred from detection of a DEN IgM to IgG ratio of <1.8. | Posted | Number | Flavivirus immunity ratio | 1 year, 30 Days Post Booster, 2 years |
|
|
|
| Secondary | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Clinical safety laboratory test were monitored for alert levels. Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Normal Ranges: Alanine Aminotransferases (ALT): LNL=0 and UNL=30 Aspartate Aminotransferases (AST): LNL=0 and UNL=40 Platelet (PLA): LNL=150000 and UNL=350000 Hematocrit (HC): LNL=35 and UNL=45 Neutrophil (NEU): LNL=1500 and UNL=8000 | Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Tests included ALT, AST, PLA, HC, and NEU levels. | Posted | Number | U/L | Year 1 (day 0); Year 1 (day 30); Year 2 |
|
|
|
| 0 |
| 7 |
| 7 |
| 7 |
|
| Abdominial Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Fever (Axillary) | General disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Fever (Axillary) | General disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Muscle aches | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Muscle aches | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Pain behind eyes | Eye disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Pain behind eyes | Eye disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Photophobia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Photophobia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | < 2 days |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | > 2 days |
|
Not provided
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| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| Title | Measurements |
|---|---|
|
| N lg to DEN-1: Year 3 |
|
| N lg to DEN-2: Pre-booster Year 1 |
|
| N lg to DEN-2: 30 Day Post-booster |
|
| N lg to DEN-2: Year 2 |
|
| N lg to DEN-2: Year 3 |
|
| N lg to DEN-3: Pre-booster Year 1 |
|
| N lg to DEN-3: 30 Days post-booster |
|
| N lg to DEN-3: Year 2 |
|
| N lg to DEN-3: Year 3 |
|
| N lg to DEN-4: Pre-booster Year 1 |
|
| N lg to DEN-4: 30 Days Post-booster |
|
| N lg to DEN-4: Year 2 |
|
| N lg to DEN-4: Year 3 |
|
| Title | Measurements |
|---|---|
|
| Redness: Grade 3 |
|
| Swelling: All |
|
| Swelling: Grade 3 |
|
|
| Nervous System Disorders |
|
| Renal and Urinary Disorders |
|
| Respiratory, Thoracic and Mediastinal Disorders |
|
|
| Pre-Booster Year 1: Tetravalent |
|
| 30 Days Post Booster: Monovalent |
|
| 30 Days Post Booster: Bivalent |
|
| 30 Days post Booster: Trivalent |
|
| 30 Days Post Booster: Tetravalent |
|
| Year 2: Monovalent |
|
| Year 2: Bivalent |
|
| Year 2: Trivalent |
|
| Year 2: Tetravalent |
|
| Year 3: Monovalent |
|
| Year 3: Bivalent |
|
| Year 3: Trivalent |
|
| Year 3: Tetravalent |
|
| Title | Measurements |
|---|---|
|
| JEV Subject 2: Year 1 Ratio |
|
| JEV Subject 2: 30 Days Post Booster Ratio |
|
| JEV Subject 2: Year 2 Ratio |
|
| DEN Subject 3: Year 1 Ratio |
|
| DEN Subject 3: 30 Days Post Booster Ratio |
|
| DEN Subject 3: Year 2 Ratio |
|
| JEV Subject 3: Year 1 Ratio |
|
| JEV Subject 3: 30 Days Post Booster Ratio |
|
| JEV Subject 3: Year 2 Ratio |
|
| DEN Subject 4: Year 1 Ratio |
|
| DEN Subject 4: 30 Days Post Booster Ratio |
|
| DEN Subject 4: Year 2 Ratio |
|
| JEV Subject 4: Year 1 Ratio |
|
| JEV Subject 4: Year 2 Ratio |
|
| DEN Subject 5: Year 1 Ratio |
|
| DEN Subject 5: 30 Days Post Booster Ratio |
|
| DEN Subject 5: Year 2 Ratio |
|
| JEV Subject 5: Year 1 Ratio |
|
| JEV Subject 5: 30 Days Post Booster Ratio |
|
| JEV Subject 5: Year 2 Ratio |
|
| DEN Subject 6: Year 1 Ratio |
|
| DEN Subject 6: 30 Days Post Booster Ratio |
|
| DEN Subject 6: Year 2 Ratio |
|
| JEV Subject 6: Year 1 Ratio |
|
| JEV Subject 6: 30 Days Post Booster Ratio |
|
| JEV Subject 6: Year 2 Ratio |
|
| DEN Subject 7: Year 1 Ratio |
|
| DEN Subject 7: 30 Days Post Booster Ratio |
|
| DEN Subject 7: Year 2 Ratio |
|
| JEV Subject 7: Year 1 Ratio |
|
| JEV Subject 7: 30 Days Post Ratio |
|
| JEV Subject 7: Year 2 Ratio |
|
| Subject 1: Year 1, Day 10 |
|
| Subject 1: Year 1, Day 30 |
|
| Subject 1: Year 2 |
|
| Subject 2: Year 1, Day 0 |
|
| Subject 2: Year 1, Day 10 |
|
| Subject 2: Year 1, Day 30 |
|
| Subject 2: Year 2 |
|
| Subject 3: Year 1, Day 0 |
|
| Subject 3: Year 1, Day 10 |
|
| Subject 3: Year 1, Day 30 |
|
| Subject 3: Year 2 |
|
| Subject 4: Year 1, Day 0 |
|
| Subject 4: Year 1, Day 10 |
|
| Subject 4: Year 1, Day 30 |
|
| Subject 4: Year 2 |
|
| Subject 5: Year 1, Day 0 |
|
| Subject 5: Year 1, Day 10 |
|
| Subject 5: Year 1, Day 30 |
|
| Subject 5: Year 2 |
|
| Subject 6: Year 1, Day 0 |
|
| Subject 6, Year 1, Day 10 |
|
| Subject 6, Year 1, Day 30 |
|
| Subject 6, Year 2 |
|
| Subject 7: Year 1, Day 0 |
|
| Subject 7: Year 1, Day 10 |
|
| Subject 7: Year 1, Day 30 |
|
| Subject 7, Year 2 |
|