A Phase 2 interventional study of Live attenuated tetravalent dengue vaccine and Placebo in Dengue, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
This descriptive study will evaluate the safety and immunogenicity of 5 different formulations of the WRAIR dengue vaccine compared to a placebo.
Subjects will be randomized into one of 6 groups. One group will receive a placebo vaccine and the others will receive one of 5 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.
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's enrollment of 86 is below the median of 123 across 195 interventional studies indexed under Dengue.
Browse Dengue studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion:
History of:
Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Biological: Live attenuated tetravalent dengue vaccine
Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.
Biological: Live attenuated tetravalent dengue vaccine
Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.
Biological: Live attenuated tetravalent dengue vaccine
Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.
Biological: Placebo
Live attenuated tetravalent dengue vaccine
Placebo
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4
Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.
Time frame: At 30 days (Month 7) after Dose 2 of the study vaccine
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status
Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.
Time frame: At 5 to 12 months post-Dose 2 of the study vaccine
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status
Titers for DEN 1, DEN 2, DEN 3 and DEN 4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.
Time frame: At Month 1 post-booster dose of the study vaccine
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 21-day (Days 0-20) follow-up after each dose of the study vaccine
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 21-day (Days 0-20) follow-up after each dose of the study vaccine
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Days 0-30) follow-up after any study vaccine dose
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the whole primary phase of the study (from Day 0 up to Month 9)
Number of Subjects With Alert Values for Safety Laboratory Determinations
Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet).
Time frame: During the 31-day (Days 0-30) follow-up after each vaccine dose (Month 1 and Month 7)
Number of Subjects With Abnormal Findings at Dengue Physical Examination
The abnormal findings at Dengue physical examination included: Rash, Generalized Rash, Skin Hemorrhage, Conjunctival Hemorrhage, Conjunctival Injection, Mucosal Hemorrhage, Lymphadenopathy, Generalized Lymphadenopathy, Hepatomegaly and Splenomegaly. Rash involved \< 50% of the body surface; Generalized rash involved at least 50% of the body surface. Generalized lymphadenopathy was defined as palpable lymph nodes in four or more of the following locations: cervical, axillary, inguinal or other, with right and left sides considered as separate locations.
Time frame: During the 31-day (Days 0-30) follow-up after each vaccine dose and across doses
Number of Subjects With Suspected and Confirmed Dengue
The number of subjects with suspected and confirmed Dengue post-vaccination.
Time frame: During the 31-day (Days 0-30) follow-up after each vaccine dose and across doses
Number of Subjects With Measurable Dengue Viremia
The number of subjects with measurable dengue viremia at specified timepoints. Negative = Genome equivalent (GEQ)/µL result is equal to zero; Undetermined = GEQ/µL result is below limit of detection (LOD); Positive = GEQ/µL result is ≥ LOD.
Time frame: During the 31-day (Days 0-30) follow-up after each vaccine dose
Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges
Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: During the 31-day (Days 0-30) follow-up after each vaccine dose (Month 1 and Month 7)
Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4
Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.
Time frame: At Month 0 and Month 1
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype
Assay cut-off values were greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.
Time frame: At Months 0, 1 and 7
Number of Subjects With Antibody Titers Above the Assay Cut-off Value (Tetravalent Response) for All Dengue Serotypes
The antibody titers and pre-vaccination status were determined by MN50 with a cut-off value equal to 1:10.
Time frame: At Months 1 and 7
Number of Subjects With Sero-response to Each DEN Type
Sero-response defined as: For initially seronegative subjects (antibody titer \< 10 ED50 for neutralizing antibodies to DEN 1, DEN 2, DEN 3, DEN 4 prior to vaccination), antibody titer ≥ 10 ED50 at post-vaccination; For initially seropositive subjects (antibody titer ≥ 10 ED50 for neutralizing antibodies to DEN 1, DEN 2, DEN 3, DEN 4 prior to vaccination), antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: At Months 1 and 7
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 21-day (Days 0-20) follow-up after the study vaccine booster dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = oral fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 21-day (Days 0-20) follow-up after the study vaccine booster dose
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Days 0-30) follow-up after the study vaccine booster dose
Number of Subjects With SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the whole booster phase of the study (from pre-vaccination up to Month 6 post-vaccination with the booster dose)
Number of Subjects With Hematological and Biochemical Determinations Within and Outside the Normal Ranges
Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Note: No blood sample was taken for these laboratory tests at Month 6 post-booster vaccination.
Time frame: At each booster phase visit [pre-booster vaccination (PRE), study Visit 12 post-booster vaccination (Days 2, 5, 8 or 12) (FU1), study Visit 13 post-booster vaccination (Days 5, 8, 12 or 14) (FU2) and at Months 1 and 6 post-booster vaccination]
Number of Subjects With Alert Values for Safety Laboratory Determinations
Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet).
Time frame: During the 31-day (Days 0-30) follow-up after the study vaccine booster dose
Number of Subjects With Abnormal Findings at Dengue Physical Examination
The abnormal findings at Dengue physical examination included: Conjunctival hemorrhage, Conjunctival injection, Generalized lymphadenopathy, Generalized rash, Hepatomegaly, Lymphadenopathy, Mucosal hemorrhage, Rash, Skin hemorrhage and Splenomegaly. Rash involved \< 50% of the body surface; Generalized rash involved at least 50% of the body surface. Generalized lymphadenopathy was defined as palpable lymph nodes in four or more of the following locations: cervical, axillary, inguinal or other, with right and left sides considered as separate locations. Note: Results only available during the 31-day follow-up period (Month 1) after the booster dose, instead of at each booster phase visit \[pre-vaccination, study Visit 12 post-booster vaccination (Days 2, 5, 8 or 12), Visit 13 post-booster vaccination (Days 5, 8, 12 or 14) and at Months 1 and 6 post-booster vaccination\].
Time frame: At Month 1 post-booster vaccination
Number of Subjects With Suspected and Confirmed Dengue
The number of subjects with suspected and confirmed Dengue post-booster vaccination.
Time frame: During the 31-day (Days 0-30) follow-up after the study vaccine booster dose
Number of Subjects With Measurable Dengue Viremia
The number of subjects with measurable dengue viremia at specified timepoints.
Time frame: At study Visit 12 (Days 2, 5, 8 or 12) (FU1), study Visit 13 post-booster vaccination (Days 5, 8, 12 or 14) (FU2) and at study Visit 14 (Month 1 post-booster vaccination)
Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype
Assay cut-off values were greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.
Time frame: Before (PRE) and one month after the booster vaccination (Month 1)
| Milestone | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Started | 22 | 22 | 21 | 21 |
| Completed | 17 | 19 | 18 | 21 |
| Not completed | 5 | 3 | 3 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
| Withdrew: Other | 5 | 3 | 2 | 0 |
| Milestone | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Started | 0 | 9 | 12 | 0 |
| Completed | 0 | 9 | 12 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Any Pain | 7 | 2 | 4 | 5 |
| Grade 3 Pain | 0 | 0 | 0 | 1 |
| Any Redness | 8 | 3 | 4 | 4 |
| Grade 3 Redness | 1 | 1 | 0 | 0 |
| Any Swelling | 6 | 4 | 5 | 2 |
| Grade 3 Swelling | 0 | 1 | 1 | 1 |
Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Any Abdominal pain | 0 | 3 | 3 | 4 |
| Grade 3 Abdominal pain | 0 | 0 | 1 | 0 |
| Related Abdominal pain | 0 | 2 | 2 | 3 |
| Any Arthralgia | 5 | 2 | 2 | 3 |
| Grade 3 Arthralgia | 0 | 0 | 0 | 1 |
| Related Arthralgia | 4 | 2 | 2 | 2 |
| Any Fatigue | 8 | 5 | 5 | 7 |
| Grade 3 Fatigue | 0 | 0 | 1 | 1 |
| Related Fatigue | 5 | 2 | 4 | 6 |
| Any Fever | 4 | 2 | 2 | 1 |
| Grade 3 Fever | 0 | 0 | 0 | 1 |
| Related Fever | 3 | 2 | 2 | 1 |
| Any Headache | 12 | 8 | 7 | 7 |
| Grade 3 Headache | 0 | 0 | 0 | 0 |
| Related Headache | 8 | 5 | 3 | 5 |
| Any Muscle aches | 5 | 2 | 3 | 4 |
| Grade 3 Muscle aches | 0 | 0 | 0 | 2 |
| Related Muscle aches | 3 | 1 | 3 | 3 |
| Any Nausea | 5 | 3 | 3 | 1 |
| Grade 3 Nausea | 0 | 0 | 0 | 0 |
| Related Nausea | 4 | 0 | 2 | 1 |
| Any Pain behind eyes | 4 | 4 | 5 | 2 |
| Grade 3 Pain behind eyes | 0 | 0 | 0 | 0 |
| Related Pain behind eyes | 4 | 3 | 4 | 2 |
| Any Photophobia | 3 | 1 | 4 | 2 |
| Grade 3 Photophobia | 0 | 0 | 0 | 1 |
| Related Photophobia | 3 | 1 | 3 | 2 |
| Any Pruritus | 8 | 3 | 2 | 4 |
| Grade 3 Pruritus | 0 | 0 | 0 | 0 |
| Related Pruritus | 4 | 2 | 2 | 3 |
| Any Rash | 4 | 3 | 1 | 0 |
| Grade 3 Rash | 0 | 0 | 0 | 0 |
| Related Rash | 4 | 3 | 1 | 0 |
| Any Vomiting | 2 | 1 | 0 | 0 |
| Grade 3 Vomiting | 0 | 0 | 0 | 0 |
| Related Vomiting | 1 | 0 | 0 | 0 |
Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.
| ED50 | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| DEN-1 | 241 (81 to 719) | 83 (25 to 273) | 204 (69 to 603) | 7 (4 to 14) |
| DEN-2 | 691 (407 to 1175) | 223 (76 to 656) | 342 (123 to 954) | 6 (4 to 10) |
| DEN-3 | 94 (28 to 321) | 55 (17 to 177) | 96 (30 to 309) | 6 (4 to 10) |
| DEN-4 | 350 (85 to 1439) | 91 (27 to 305) | 84 (24 to 294) | 6 (4 to 8) |
Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.
| ED50 | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| DEN-1, Not primed | 15 (4 to 57) | 35 (6 to 187) |
| DEN-1, Primed | 521 (40 to 6785) | 2430 (2430 to 2430) |
| DEN-2, Not primed | 33 (5 to 203) | 30 (6 to 158) |
| DEN-2, Primed | 346 (0 to 97683203) | 673 (10 to 46541) |
| DEN-3, Not primed | 7 (3 to 20) | 12 (4 to 38) |
| DEN-3, Primed | 426 (0 to 785070000000000) | 1413 (1165 to 1715) |
| DEN-4, Not primed | 29 (2 to 521) | 23 (3 to 168) |
| DEN-4, Primed | 123 (0 to 15158843) | 766 (1 to 959438) |
Titers for DEN 1, DEN 2, DEN 3 and DEN 4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.
| ED50 | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| DEN-1, Not primed | 39 (7 to 226) | 73 (19 to 281) |
| DEN-1, Primed | 672 (55 to 8245) | 2430 (2430 to 2430) |
| DEN-2, Not primed | 104 (15 to 720) | 194 (56 to 675) |
| DEN-2, Primed | 909 (3 to 255163) | 795 (734 to 861) |
| DEN-3, Not primed | 34 (5 to 226) | 19 (5 to 69) |
| DEN-3, Primed | 890 (0 to 13080837) | 1502 (645 to 3498) |
| DEN-4, Not primed | 46 (4 to 535) | 31 (4 to 231) |
| DEN-4, Primed | 215 (99 to 463) | 618 (0 to 2096791) |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Any Pain | 7 | 1 | 1 | 2 |
| Grade 3 Pain | 0 | 0 | 0 | 0 |
| Any Redness | 1 | 0 | 2 | 2 |
| Grade 3 Redness | 0 | 0 | 0 | 0 |
| Any Swelling | 1 | 0 | 0 | 1 |
| Grade 3 Swelling | 0 | 0 | 0 | 0 |
Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Any Abdominal pain | 0 | 3 | 1 | 1 |
| Grade 3 Abdominal pain | 0 | 0 | 0 | 0 |
| Related Abdominal pain | 0 | 2 | 0 | 1 |
| Any Arthralgia | 1 | 2 | 2 | 0 |
| Grade 3 Arthralgia | 0 | 1 | 0 | 0 |
| Related Arthralgia | 1 | 2 | 1 | 0 |
| Any Fatigue | 4 | 4 | 3 | 3 |
| Grade 3 Fatigue | 0 | 1 | 0 | 0 |
| Related Fatigue | 3 | 2 | 1 | 1 |
| Any Fever | 1 | 2 | 1 | 4 |
| Grade 3 Fever | 0 | 0 | 0 | 0 |
| Related Fever | 1 | 2 | 0 | 2 |
| Any Headache | 6 | 5 | 3 | 5 |
| Grade 3 Headache | 0 | 1 | 1 | 0 |
| Related Headache | 3 | 4 | 1 | 3 |
| Any Muscle aches | 1 | 4 | 1 | 0 |
| Grade 3 Muscle aches | 0 | 1 | 0 | 0 |
| Related Muscle aches | 1 | 2 | 1 | 0 |
| Any Nausea | 1 | 3 | 0 | 1 |
| Grade 3 Nausea | 0 | 0 | 0 | 0 |
| Related Nausea | 1 | 2 | 0 | 1 |
| Any Pain behind eyes | 1 | 4 | 1 | 1 |
| Grade 3 Pain behind eyes | 0 | 0 | 0 | 0 |
| Related Pain behind eyes | 0 | 2 | 0 | 0 |
| Any Photophobia | 1 | 2 | 0 | 2 |
| Grade 3 Photophobia | 0 | 0 | 0 | 0 |
| Related Photophobia | 1 | 1 | 0 | 1 |
| Any Pruritus | 2 | 0 | 1 | 1 |
| Grade 3 Pruritus | 0 | 0 | 0 | 0 |
| Related Pruritus | 2 | 0 | 1 | 1 |
| Any Rash | 3 | 0 | 2 | 0 |
| Grade 3 Rash | 0 | 0 | 0 | 0 |
| Related Rash | 3 | 0 | 2 | 0 |
| Any Vomiting | 0 | 1 | 0 | 0 |
| Grade 3 Vomiting | 0 | 0 | 0 | 0 |
| Related Vomiting | 0 | 0 | 0 | 0 |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Any Pain | 9 | 3 | 5 | 5 |
| Grade 3 Pain | 0 | 0 | 0 | 1 |
| Any Redness | 8 | 3 | 5 | 5 |
| Grade 3 Redness | 1 | 1 | 0 | 0 |
| Any Swelling | 7 | 4 | 5 | 3 |
| Grade 3 Swelling | 0 | 1 | 1 | 1 |
Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Any Abdominal pain | 0 | 5 | 4 | 4 |
| Grade 3 Abdominal pain | 0 | 0 | 1 | 0 |
| Related Abdominal pain | 0 | 3 | 2 | 3 |
| Any Arthralgia | 6 | 4 | 3 | 3 |
| Grade 3 Arthralgia | 0 | 1 | 0 | 1 |
| Related Arthralgia | 5 | 4 | 3 | 2 |
| Any Fatigue | 10 | 8 | 6 | 7 |
| Grade 3 Fatigue | 0 | 1 | 1 | 1 |
| Related Fatigue | 7 | 3 | 5 | 6 |
| Any Fever | 5 | 4 | 3 | 5 |
| Grade 3 Fever | 0 | 0 | 0 | 1 |
| Related Fever | 4 | 4 | 2 | 3 |
| Any Headache | 14 | 9 | 10 | 9 |
| Grade 3 Headache | 0 | 1 | 1 | 0 |
| Related Headache | 9 | 6 | 4 | 7 |
| Any Muscle aches | 6 | 5 | 4 | 4 |
| Grade 3 Muscle aches | 0 | 1 | 0 | 2 |
| Related Muscle aches | 4 | 3 | 4 | 3 |
| Any Nausea | 6 | 4 | 3 | 2 |
| Grade 3 Nausea | 0 | 0 | 0 | 0 |
| Related Nausea | 5 | 2 | 2 | 2 |
| Any Pain behind the eyes | 4 | 7 | 5 | 3 |
| Grade 3 Pain behind the eyes | 0 | 0 | 0 | 0 |
| Related Pain behind the eyes | 4 | 5 | 4 | 2 |
| Any Photophobia | 4 | 3 | 4 | 4 |
| Grade 3 Photophobia | 0 | 0 | 0 | 1 |
| Related Photophobia | 4 | 2 | 3 | 3 |
| Any Pruritus | 9 | 3 | 3 | 4 |
| Grade 3 Pruritus | 0 | 0 | 0 | 0 |
| Related Pruritus | 6 | 2 | 3 | 3 |
| Any Rash | 7 | 3 | 3 | 0 |
| Grade 3 Rash | 0 | 0 | 0 | 0 |
| Related Rash | 7 | 3 | 3 | 0 |
| Any Vomiting | 2 | 2 | 0 | 0 |
| Grade 3 Vomiting | 0 | 0 | 0 | 0 |
| Related Vomiting | 1 | 0 | 0 | 0 |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs) | 15 | 10 | 15 | 12 |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 0 | 0 | 1 | 1 |
Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet).
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| ALT, Month 1 | 0 | 0 | 0 | 0 |
| ALT, Month 7 | 0 | 0 | 0 | 0 |
| AST, Month 1 | 0 | 0 | 0 | 0 |
| AST, Month 7 | 0 | 0 | 0 | 0 |
| HC, Month 1 | 0 | 0 | 0 | 0 |
| HC, Month 7 | 0 | 0 | 0 | 0 |
| NEU, Month 1 | 0 | 0 | 0 | 0 |
| NEU, Month 7 | 0 | 0 | 0 | 0 |
| Platelet, Month 1 | 0 | 0 | 0 | 0 |
| Platelet, Month 7 | 0 | 0 | 0 | 0 |
The abnormal findings at Dengue physical examination included: Rash, Generalized Rash, Skin Hemorrhage, Conjunctival Hemorrhage, Conjunctival Injection, Mucosal Hemorrhage, Lymphadenopathy, Generalized Lymphadenopathy, Hepatomegaly and Splenomegaly. Rash involved \< 50% of the body surface; Generalized rash involved at least 50% of the body surface. Generalized lymphadenopathy was defined as palpable lymph nodes in four or more of the following locations: cervical, axillary, inguinal or other, with right and left sides considered as separate locations.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Rash, Dose 1 | 1 | 0 | 1 | 0 |
| Generalized Rash, Dose 1 | 0 | 0 | 1 | 0 |
| Skin Hemorrhage, Dose 1 | 0 | 0 | 0 | 1 |
| Conjunctival Hemorrhage, Dose 1 | 0 | 0 | 0 | 0 |
| Conjunctival Injection, Dose 1 | 2 | 0 | 1 | 1 |
| Mucosal Hemorrhage, Dose 1 | 2 | 1 | 1 | 1 |
| Lymphadenopathy, Dose 1 | 3 | 3 | 4 | 3 |
| Generalized Lymphadenopathy,Dose 1 | 0 | 1 | 0 | 1 |
| Hepatomegaly, Dose 1 | 2 | 3 | 5 | 2 |
| Splenomegaly, Dose 1 | 0 | 1 | 1 | 1 |
| Rash, Dose 2 | 2 | 1 | 2 | 0 |
| Generalized Rash, Dose 2 | 1 | 0 | 1 | 0 |
| Skin Hemorrhage, Dose 2 | 0 | 0 | 0 | 0 |
| Conjunctival Hemorrhage, Dose 2 | 0 | 0 | 0 | 1 |
| Conjunctival Injection, Dose 2 | 1 | 1 | 2 | 0 |
| Mucosal Hemorrhage, Dose 2 | 0 | 0 | 0 | 0 |
| Lymphadenopathy, Dose 2 | 1 | 3 | 5 | 3 |
| Generalized Lymphadenopathy,Dose 2 | 0 | 0 | 0 | 0 |
| Hepatomegaly, Dose 2 | 1 | 0 | 3 | 3 |
| Splenomegaly, Dose 2 | 0 | 0 | 0 | 2 |
| Rash, Across | 3 | 1 | 3 | 0 |
| Generalized Rash, Across | 1 | 0 | 2 | 0 |
| Skin Hemorrhage, Across | 0 | 0 | 0 | 1 |
| Conjunctival Hemorrhage, Across | 0 | 0 | 0 | 1 |
| Conjunctival Injection, Across | 2 | 1 | 2 | 1 |
| Mucosal Hemorrhage, Across | 2 | 1 | 1 | 1 |
| Lymphadenopathy, Across | 4 | 6 | 7 | 4 |
| Generalized Lymphadenopathy,Across | 0 | 1 | 0 | 1 |
| Hepatomegaly, Across | 2 | 3 | 6 | 4 |
| Splenomegaly, Across | 0 | 1 | 1 | 2 |
The number of subjects with suspected and confirmed Dengue post-vaccination.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Suspected dengue, Dose 1 | 1 | 0 | 0 | 1 |
| Confirmed dengue, Dose 1 | 0 | 0 | 0 | 0 |
| Suspected dengue, Dose 2 | 0 | 0 | 0 | 0 |
| Confirmed dengue, Dose 2 | 0 | 0 | 0 | 0 |
| Suspected dengue, Across doses | 1 | 0 | 0 | 1 |
| Confirmed dengue, Across doses | 0 | 0 | 0 | 0 |
The number of subjects with measurable dengue viremia at specified timepoints. Negative = Genome equivalent (GEQ)/µL result is equal to zero; Undetermined = GEQ/µL result is below limit of detection (LOD); Positive = GEQ/µL result is ≥ LOD.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| DEN-1 Positive, Dose 1 | 0 | 0 | 0 | 0 |
| DEN-1 Undetermined, Dose 1 | 2 | 1 | 2 | 1 |
| DEN-1 Negative, Dose 1 | 18 | 21 | 19 | 20 |
| DEN-1 Missing, Dose 1 | 2 | 0 | 0 | 0 |
| DEN-1 Positive, Dose 2 | 0 | 0 | 0 | 0 |
| DEN-1 Undetermined, Dose 2 | 1 | 2 | 2 | 1 |
| DEN-1 Negative, Dose 2 | 15 | 17 | 16 | 19 |
| DEN-1 Missing, Dose 2 | 6 | 3 | 3 | 1 |
| DEN-1 Positive, Across doses | 0 | 0 | 0 | 0 |
| DEN-1 Undetermined, Across doses | 3 | 3 | 3 | 2 |
| DEN-1 Negative, Across doses | 13 | 16 | 15 | 18 |
| DEN-1 Missing, Across doses | 6 | 3 | 3 | 1 |
| DEN-2 Positive, Dose 1 | 0 | 0 | 0 | 0 |
| DEN-2 Undetermined, Dose 1 | 1 | 1 | 0 | 0 |
| DEN-2 Negative, Dose 1 | 18 | 20 | 19 | 19 |
| DEN-2 Missing, Dose 1 | 3 | 1 | 2 | 2 |
| DEN-2 Positive, Dose 2 | 0 | 0 | 0 | 0 |
| DEN-2 Undetermined, Dose 2 | 0 | 1 | 1 | 0 |
| DEN-2 Negative, Dose 2 | 15 | 17 | 15 | 18 |
| DEN-2 Missing, Dose 2 | 7 | 4 | 5 | 3 |
| DEN-2 Positive, Across doses | 0 | 0 | 0 | 0 |
| DEN-2 Undetermined, Across doses | 0 | 2 | 1 | 0 |
| DEN-2 Negative, Across doses | 15 | 16 | 15 | 18 |
| DEN-2 Missing, Across doses | 7 | 4 | 5 | 3 |
| DEN-3 Positive, Dose 1 | 0 | 0 | 0 | 0 |
| DEN-3 Undetermined, Dose 1 | 0 | 0 | 0 | 0 |
| DEN-3 Negative, Dose 1 | 20 | 22 | 21 | 21 |
| DEN-3 Missing, Dose 1 | 2 | 0 | 0 | 0 |
| DEN-3 Positive, Dose 2 | 0 | 0 | 0 | 0 |
| DEN-3 Undetermined, Dose 2 | 0 | 0 | 0 | 0 |
| DEN-3 Negative, Dose 2 | 16 | 19 | 18 | 20 |
| DEN-3 Missing, Dose 2 | 6 | 3 | 3 | 1 |
| DEN-3 Positive, Across doses | 0 | 0 | 0 | 0 |
| DEN-3 Undetermined, Across doses | 0 | 0 | 0 | 0 |
| DEN-3 Negative, Across doses | 16 | 19 | 18 | 20 |
| DEN-3 Missing, Across doses | 6 | 3 | 3 | 1 |
| DEN-4 Positive, Dose 1 | 2 | 1 | 0 | 0 |
| DEN-4 Undetermined, Dose 1 | 1 | 1 | 1 | 0 |
| DEN-4 Negative, Dose 1 | 17 | 20 | 20 | 21 |
| DEN-4 Missing, Dose 1 | 2 | 0 | 0 | 0 |
| DEN-4 Positive, Dose 2 | 3 | 0 | 0 | 0 |
| DEN-4 Undetermined, Dose 2 | 0 | 0 | 0 | 0 |
| DEN-4 Negative, Dose 2 | 13 | 19 | 18 | 20 |
| DEN-4 Missing, Dose 2 | 6 | 3 | 3 | 1 |
| DEN-4 Positive, Across doses | 5 | 1 | 0 | 0 |
| DEN-4 Undetermined, Across doses | 1 | 1 | 1 | 0 |
| DEN-4 Negative, Across doses | 11 | 17 | 17 | 20 |
| DEN-4 Missing, Across doses | 5 | 3 | 3 | 1 |
Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| ALT Below, Month 1 | 0 | 0 | 0 | 0 |
| ALT Above, Month 1 | 1 | 1 | 1 | 2 |
| ALT Below, Month 7 | 0 | 0 | 0 | 0 |
| ALT Above, Month 7 | 0 | 0 | 0 | 0 |
| AST Below, Month 1 | 0 | 0 | 0 | 0 |
| AST Above, Month 1 | 0 | 1 | 2 | 1 |
| AST Below, Month 7 | 0 | 0 | 0 | 0 |
| AST Above, Month 7 | 0 | 0 | 0 | 0 |
| HC Below, Month 1 | 0 | 6 | 2 | 4 |
| HC Above, Month 1 | 0 | 0 | 0 | 0 |
| HC Below, Month 7 | 3 | 3 | 3 | 3 |
| HC Above, Month 7 | 0 | 0 | 0 | 0 |
| NEU Below, Month 1 | 1 | 0 | 0 | 1 |
| NEU Above, Month 1 | 0 | 0 | 0 | 0 |
| NEU Below, Month 7 | 0 | 1 | 0 | 1 |
| NEU Above, Month 7 | 0 | 0 | 0 | 2 |
| Platelet Below, Month 1 | 0 | 0 | 0 | 0 |
| Platelet Above, Month 1 | 0 | 1 | 2 | 0 |
| Platelet Below, Month 7 | 0 | 0 | 0 | 0 |
| Platelet Above, Month 7 | 0 | 0 | 0 | 0 |
Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.
| ED50 | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| DEN-1, Month 0 | 10 (5 to 22) | 10 (4 to 24) | 13 (4 to 41) | 7 (4 to 12) |
| DEN-1, Month 1 | 51 (15 to 179) | 20 (8 to 50) | 127 (36 to 450) | 7 (3 to 14) |
| DEN-2, Month 0 | 9 (5 to 17) | 11 (4 to 26) | 11 (4 to 29) | 7 (4 to 10) |
| DEN-2, Month 1 | 230 (84 to 630) | 94 (34 to 261) | 287 (95 to 870) | 7 (4 to 10) |
| DEN-3, Month 0 | 8 (5 to 14) | 11 (5 to 25) | 10 (4 to 25) | 6 (4 to 9) |
| DEN-3, Month 1 | 41 (13 to 124) | 22 (10 to 51) | 43 (14 to 135) | 6 (4 to 10) |
| DEN-4, Month 0 | 9 (5 to 19) | 8 (4 to 16) | 10 (4 to 23) | 6 (4 to 7) |
| DEN-4, Month 1 | 59 (16 to 224) | 52 (16 to 173) | 63 (17 to 238) | 6 (5 to 8) |
Assay cut-off values were greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| DEN-1, Month 0 | 4 | 3 | 3 | 1 |
| DEN-1, Month 1 | 11 | 9 | 13 | 1 |
| DEN-1, Month 7 | 15 | 14 | 13 | 2 |
| DEN-2, Month 0 | 4 | 3 | 3 | 3 |
| DEN-2, Month 1 | 18 | 15 | 16 | 2 |
| DEN-2, Month 7 | 16 | 15 | 15 | 2 |
| DEN-3, Month 0 | 4 | 4 | 3 | 1 |
| DEN-3, Month 1 | 12 | 12 | 12 | 1 |
| DEN-3, Month 7 | 12 | 13 | 13 | 2 |
| DEN-4, Month 0 | 4 | 3 | 3 | 1 |
| DEN-4, Month 1 | 10 | 12 | 11 | 3 |
| DEN-4, Month 7 | 13 | 14 | 11 | 1 |
The antibody titers and pre-vaccination status were determined by MN50 with a cut-off value equal to 1:10.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Unprimed, Month 1 | 6 | 6 | 6 | 0 |
| Unprimed, Month 7 | 10 | 9 | 8 | 0 |
| Primed, Month 1 | 4 | 3 | 3 | 1 |
| Primed, Month 7 | 2 | 3 | 3 | 1 |
Sero-response defined as: For initially seronegative subjects (antibody titer \< 10 ED50 for neutralizing antibodies to DEN 1, DEN 2, DEN 3, DEN 4 prior to vaccination), antibody titer ≥ 10 ED50 at post-vaccination; For initially seropositive subjects (antibody titer ≥ 10 ED50 for neutralizing antibodies to DEN 1, DEN 2, DEN 3, DEN 4 prior to vaccination), antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
| Participants | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| DEN-1, Month 1 | 10 | 6 | 10 | 0 |
| DEN-1, Month 7 | 14 | 11 | 10 | 1 |
| DEN-2, Month 1 | 16 | 13 | 14 | 0 |
| DEN-2, Month 7 | 14 | 13 | 13 | 0 |
| DEN-3, Month 1 | 11 | 8 | 10 | 0 |
| DEN-3, Month 7 | 11 | 11 | 11 | 1 |
| DEN-4, Month 1 | 9 | 10 | 9 | 2 |
| DEN-4, Month 7 | 12 | 12 | 9 | 0 |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| Any Pain | 0 | 0 |
| Grade 3 Pain | 0 | 0 |
| Any Redness | 1 | 2 |
| Grade 3 Redness | 0 | 0 |
| Any Swelling | 0 | 1 |
| Grade 3 Swelling | 0 | 0 |
Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = oral fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| Any Abdominal pain | 0 | 1 |
| Grade 3 Abdominal pain | 0 | 0 |
| Related Abdominal pain | 0 | 0 |
| Any Arthralgia | 0 | 0 |
| Grade 3 Arthralgia | 0 | 0 |
| Related Arthralgia | 0 | 0 |
| Any Fatigue | 1 | 0 |
| Grade 3 Fatigue | 0 | 0 |
| Related Fatigue | 1 | 0 |
| Any Fever | 3 | 0 |
| Grade 3 Fever | 0 | 0 |
| Related Fever | 2 | 0 |
| Any Headache | 2 | 0 |
| Grade 3 Headache | 0 | 0 |
| Related Headache | 2 | 0 |
| Any Muscle aches | 0 | 0 |
| Grade 3 Muscle aches | 0 | 0 |
| Related Muscle aches | 0 | 0 |
| Any Nausea | 1 | 1 |
| Grade 3 Nausea | 0 | 0 |
| Related Nausea | 0 | 0 |
| Any Pain behind eyes | 0 | 0 |
| Grade 3 Pain behind eyes | 0 | 0 |
| Related Pain behind eyes | 0 | 0 |
| Any Photophobia | 0 | 1 |
| Grade 3 Photophobia | 0 | 0 |
| Related Photophobia | 0 | 1 |
| Any Pruritus | 0 | 0 |
| Grade 3 Pruritus | 0 | 0 |
| Related Pruritus | 0 | 0 |
| Any Rash | 0 | 0 |
| Grade 3 Rash | 0 | 0 |
| Related Rash | 0 | 0 |
| Any Vomiting | 1 | 0 |
| Grade 3 Vomiting | 0 | 0 |
| Related Vomiting | 0 | 0 |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| Any AE(s) | 6 | 3 |
| Grade 3 AE(s) | 2 | 0 |
| Related AE(s) | 0 | 1 |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| Number of Subjects With SAEs | 2 | 0 |
Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Note: No blood sample was taken for these laboratory tests at Month 6 post-booster vaccination.
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| ALT Within, PRE | 9 | 12 |
| ALT Within, FU1 | 9 | 12 |
| ALT Within, FU2 | 9 | 12 |
| ALT Within, Month 1 | 9 | 12 |
| ALT Below, PRE | 0 | 0 |
| ALT Below, FU1 | 0 | 0 |
| ALT Below, FU2 | 0 | 0 |
| ALT Below, Month 1 | 0 | 0 |
| ALT Above, PRE | 0 | 0 |
| ALT Above, FU1 | 0 | 0 |
| ALT Above, FU2 | 0 | 0 |
| ALT Above, Month 1 | 0 | 0 |
| AST Within, PRE | 9 | 12 |
| AST Within, FU1 | 9 | 12 |
| AST Within, FU2 | 9 | 12 |
| AST Within, Month 1 | 9 | 12 |
| AST Below, PRE | 0 | 0 |
| AST Below, FU1 | 0 | 0 |
| AST Below, FU2 | 0 | 0 |
| AST Below, Month 1 | 0 | 0 |
| AST Above, PRE | 0 | 0 |
| AST Above, FU1 | 0 | 0 |
| AST Above, FU2 | 0 | 0 |
| AST Above, Month 1 | 0 | 0 |
| HC Within, PRE | 8 | 10 |
| HC Within, FU1 | 8 | 9 |
| HC Within, FU2 | 8 | 11 |
| HC Within, Month 1 | 8 | 12 |
| HC Below, PRE | 1 | 2 |
| HC Below, FU1 | 1 | 3 |
| HC Below, FU2 | 1 | 1 |
| HC Below, Month 1 | 1 | 0 |
| HC Above, PRE | 0 | 0 |
| HC Above, FU1 | 0 | 0 |
| HC Above, FU2 | 0 | 0 |
| HC Above, Month 1 | 0 | 0 |
| NEU Within, PRE | 9 | 11 |
| NEU Within, FU1 | 8 | 12 |
| NEU Within, FU2 | 8 | 12 |
| NEU Within, Month 1 | 7 | 12 |
| NEU Below, PRE | 0 | 0 |
| NEU Below, FU1 | 1 | 0 |
| NEU Below, FU2 | 0 | 0 |
| NEU Below, Month 1 | 2 | 0 |
| NEU Above, PRE | 0 | 1 |
| NEU Above, FU1 | 0 | 0 |
| NEU Above, FU2 | 1 | 0 |
| NEU Above, Month 1 | 0 | 0 |
| Platelet Within, PRE | 9 | 12 |
| Platelet Within, FU1 | 9 | 12 |
| Platelet Within, FU2 | 9 | 12 |
| Platelet Within, Month 1 | 8 | 12 |
| Platelet Below, PRE | 0 | 0 |
| Platelet Below, FU1 | 0 | 0 |
| Platelet Below, FU2 | 0 | 0 |
| Platelet Below, Month 1 | 0 | 0 |
| Platelet Above, PRE | 0 | 0 |
| Platelet Above, FU1 | 0 | 0 |
| Platelet Above, FU2 | 0 | 0 |
| Platelet Above, Month 1 | 1 | 0 |
Among assessed haematological and biochemical parameters were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), hematocrit (HC), absolute neutrophil count (NEU) and platelet count (Platelet).
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| ALT | 0 | 0 |
| AST | 0 | 0 |
| HC | 0 | 0 |
| NEU | 0 | 0 |
| Platelet | 0 | 0 |
The abnormal findings at Dengue physical examination included: Conjunctival hemorrhage, Conjunctival injection, Generalized lymphadenopathy, Generalized rash, Hepatomegaly, Lymphadenopathy, Mucosal hemorrhage, Rash, Skin hemorrhage and Splenomegaly. Rash involved \< 50% of the body surface; Generalized rash involved at least 50% of the body surface. Generalized lymphadenopathy was defined as palpable lymph nodes in four or more of the following locations: cervical, axillary, inguinal or other, with right and left sides considered as separate locations. Note: Results only available during the 31-day follow-up period (Month 1) after the booster dose, instead of at each booster phase visit \[pre-vaccination, study Visit 12 post-booster vaccination (Days 2, 5, 8 or 12), Visit 13 post-booster vaccination (Days 5, 8, 12 or 14) and at Months 1 and 6 post-booster vaccination\].
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| Conjunctival hemorrhage | 0 | 0 |
| Conjunctival injection | 0 | 0 |
| Generalized lymphadenopathy | 0 | 0 |
| Generalized rash | 0 | 0 |
| Hepatomegaly | 0 | 2 |
| Lymphadenopathy | 1 | 2 |
| Mucosal hemorrhage | 1 | 0 |
| Rash | 0 | 0 |
| Skin hemorrhage | 0 | 0 |
| Splenomegaly | 0 | 0 |
The number of subjects with suspected and confirmed Dengue post-booster vaccination.
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| Suspected dengue | 0 | 0 |
| Confirmed dengue | 0 | 0 |
The number of subjects with measurable dengue viremia at specified timepoints.
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| DEN-1 Positive, FU1 | 0 | 0 |
| DEN-2 Positive, FU1 | 0 | 0 |
| DEN-3 Positive, FU1 | 0 | 0 |
| DEN-4 Positive, FU1 | 0 | 0 |
| DEN-1 Positive, FU2 | 0 | 0 |
| DEN-2 Positive, FU2 | 0 | 0 |
| DEN-3 Positive, FU2 | 0 | 0 |
| DEN-4 Positive, FU2 | 0 | 0 |
| DEN-1 Positive, Month 1 | 0 | 0 |
| DEN-2 Positive, Month 1 | 0 | 1 |
| DEN-3 Positive, Month 1 | 0 | 0 |
| DEN-4 Positive, Month 1 | 0 | 0 |
Assay cut-off values were greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.
| Participants | Dengue Formulation 17b Group | Dengue Formulation 19 Group |
|---|---|---|
| DEN-1 Not primed, PRE | 4 | 5 |
| DEN-1 Not primed, Month 1 | 5 | 7 |
| DEN-1 Primed, PRE | 2 | 2 |
| DEN-1 Primed, Month 1 | 2 | 2 |
| DEN-2 Not primed, PRE | 4 | 4 |
| DEN-2 Not primed, Month 1 | 5 | 7 |
| DEN-2 Primed, PRE | 2 | 2 |
| DEN-2 Primed, Month 1 | 2 | 2 |
| DEN-3 Not primed, PRE | 1 | 3 |
| DEN-3 Not primed, Month 1 | 5 | 4 |
| DEN-3 Primed, PRE | 2 | 2 |
| DEN-3 Primed, Month 1 | 2 | 2 |
| DEN-4 Not primed, PRE | 2 | 3 |
| DEN-4 Not primed, Month 1 | 5 | 4 |
| DEN-4 Primed, PRE | 2 | 2 |
| DEN-4 Primed, Month 1 | 2 | 2 |
Collected over Solicited local and general symptoms: during the 21-day (Days 0-20) follow up period after primary vaccination; Unsolicited AEs: during the 31-day (Days 0-30) follow up period after primary vaccination; SAEs: throughout the whole study period (from Day 0 up to Month 6 post-booster vaccination).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dengue Formulation 17a Group | 0/22 (0%) | 0/22 (0%) | 20/22 (90.9%) |
| Dengue Formulation 17b Group | 0/22 (0%) | 1/22 (4.5%) | 19/22 (86.4%) |
| Dengue Formulation 19 Group | 0/21 (0%) | 1/21 (4.8%) | 18/21 (85.7%) |
| Placebo Group | 0/21 (0%) | 1/21 (4.8%) | 16/21 (76.2%) |
| Event | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| Procedural hypertentionInjury, poisoning and procedural complications | 0/22 | 1/9 | 0/12 | 0/21 |
| Hodgkin's diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/22 | 1/9 | 0/12 | 0/21 |
| Demyelinating polyneuropathyNervous system disorders | 0/22 | 0/22 | 1/21 | 0/21 |
| Physical assaultSocial circumstances | 0/22 | 0/22 | 0/21 | 1/21 |
| Event | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group |
|---|---|---|---|---|
| HeadacheNervous system disorders | 14/22 | 9/22 | 10/21 | 9/21 |
| FatigueGeneral disorders | 10/22 | 8/22 | 6/21 | 7/21 |
| PainGeneral disorders | 9/22 | 3/22 | 5/21 | 5/21 |
| PruritusSkin and subcutaneous tissue disorders | 9/22 | 3/22 | 3/21 | 4/21 |
| ErythemaSkin and subcutaneous tissue disorders | 8/22 | 3/22 | 5/21 | 6/21 |
| Eye painEye disorders | 4/22 | 7/22 | 5/21 | 3/21 |
| RashSkin and subcutaneous tissue disorders | 7/22 | 3/22 | 3/21 | 0/21 |
| SwellingGeneral disorders | 7/22 | 5/22 | 5/21 | 3/21 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 6/22 | 4/22 | 3/21 | 3/21 |
| MyalgiaMusculoskeletal and connective tissue disorders | 6/22 | 5/22 | 4/21 | 4/21 |
| Age, Continuous(Years) | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group | Total |
|---|---|---|---|---|---|
| Mean | 35.90 ± 7.75 | 32.80 ± 6.93 | 33.0 ± 8.60 | 35.8 ± 6.70 | 34.37 ± 7.54 |
| Sex: Female, Male(Participants) | Dengue Formulation 17a Group | Dengue Formulation 17b Group | Dengue Formulation 19 Group | Placebo Group | Total |
|---|---|---|---|---|---|
| Female | 6 | 11 | 8 | 10 | 35 |
| Male | 16 | 11 | 13 | 11 | 51 |
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline