Healthy Volunteers
Conditions
Keywords
Drug therapy
Brief summary
The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.
Detailed description
The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). TDV is being tested to protect people against dengue fever and to look at long-term safety results. This study will look at the success rate of TDV in preventing dengue fever (vaccine efficacy) and long-term side effects of the vaccine. The study will be conducted in 5 parts. Part 1 will evaluate vaccine efficacy (VE) and will last a minimum of 15 months. Part 2 will be for an additional 6 months to evaluate VE. Part 3 will evaluate long-term safety by following participants for side effects and will last an additional 3 years. Part 4 will evaluate safety for 13 months post-booster vaccination. Part 5 will be the long-term safety follow-up for 1 year after completion of Part 4. Participants may be enrolled into a dry-run to commence and test febrile surveillance methodology; this dry-run part may be up to 10 months prior to receiving study injection, however, will not be applicable to all trials sites or participants. Approximately 20,100 participants will be enrolled into the study and randomly assigned (by chance) to one of the two treatment groups-which will remain undisclosed to the participants and study doctors during the study (unless there is an urgent medical need): * TDV 0.5 mL subcutaneous injection * Placebo (dummy inactive subcutaneous injection) - this is a solution that looks like the study drug but has no active ingredient All participants will receive a single injection of TDV or placebo on Day 1, Day 90. Participation in a booster phase will be offered to approximately 10,500 participants to receive (TDV or placebo) on Day 1b (Day 1 in booster phase). A subset of participants will be asked to record any local symptoms at the injection site (Pain, Erythema and Swelling) in a diary card for 7 days after each injection. The same subset of participants will also be asked to record any systemic symptoms (child \<6 years: fever, irritability/fussiness, drowsiness, loss of appetite and child ≥6 years: fever, headache, asthenia, malaise and myalgia) in a diary card for 14 days after each injection. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 7 years excluding the dry-run. Participants will make multiple visits to the clinic and will be contacted at least every week for the entire study duration.
Interventions
DRUGPlacebo
TDV placebo-matching SC injection.
BIOLOGICALTetravalent Dengue Vaccine (TDV)
TDV SC injection.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is aged 4 to 16 years, inclusive, at the time of randomization. 2. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator. 3. The participant and/or the participant's parent/guardian signs and dates an assent/written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements. 4. Can comply with trial procedures and are available for the duration of follow-up. Inclusion criteria for Booster Phase: 1. Is included in the per-protocol set (PPS) of the trial. 2. Was aged 4 to 11 years at the time of randomization in the study (Day 1 \[Month 0\]).
Exclusion criteria
1. Has febrile illness (temperature ≥38°C) or moderate or severe acute illness or infection at the time of randomization. 2. Has history of or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial. 3. Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within 28 days after Day 1 (Month 0). 4. Has participated in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial. 5. Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine. 6. Is first degree relative of individuals involved in trial conduct. 7. Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month 0). 8. Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks post-second vaccination. 9. Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily. 10. Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures. 11. Identified as an employee of the Investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 1 (Month 15) when at least 120 cases of dengue fever were confirmed and minimum duration of participant follow-up was 12 months post-second vaccination | The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype | From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2. |
| VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline | From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2. |
| VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline | From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21) | VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2. |
| VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype | From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2. |
| Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Days 1 through 7 after each vaccination | Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Days 1 through 14 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3) | Solicited systemic AEs in children (\< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥ 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except fever) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for fever were derived from the recorded body temperature measurements and presented using the proposed temperature increments published by the Brighton Collaboration. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. |
| VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2. |
| Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2 | From Day 1 until the end of Parts 1 (Month 15) and 2 (Month 21) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. In the category 'Part 1 and 2 combined' participants are counted only once even if they experienced events in both Part 1 and Part 2 in order to yield total of unique participants who had SAEs. |
| Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 | First and Second half (18 months each) of Part 3 (up to 3 years, beginning at Month 22) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. |
| Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. |
| Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent), and four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) and at least trivalent (seropositive for ≥3 dengue serotypes), is derived from the titers of dengue-neutralizing antibodies. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years) | GMTs of neutralizing antibodies were measured via microneutralization test 50% (MNT50). The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. |
| Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset | Days 1 through 28 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Percentages were rounded off to the nearest single decimal place. |
Other
| Measure | Time frame | Description |
|---|---|---|
| VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined | From 30 days post-booster vaccination (Day 30b [Month 1b) until the end of Part 5 (Month 25b) | The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to. |
| VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever. |
| Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Days 1b through 7b after booster vaccination in Part 4 | Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Days 1b through 14b after booster vaccination in Part 4 | Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except fever) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for fever were derived from the recorded body temperature measurements and presented using the proposed temperature increments published by the Brighton Collaboration. Percentages were rounded off to the nearest single decimal place except the data point where rounding-up may lead to data misinterpretation. |
| Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Days 1b through 28b after booster vaccination in Part 4 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Percentages were rounded off to the nearest single decimal place. |
| Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5 | From Day 1b until the end of Part 4 (Month 13b) and Part 5 (Month 25b) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. In the category 'Part 4 and 5 combined' participants are counted only once even if they experienced events in both Part 4 and Part 5 in order to yield total of unique participants who had SAEs. |
| Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | From Day 1b until the end of Part 4 (Month 13b) and Part 5 (Month 25b) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. In the category 'Part 4 and 5 combined' participants are counted only once even if they experienced events in both Part 4 and Part 5 in order to yield total of unique participants who had SAEs. |
| Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) and Day 760b (Month 25b) in Parts 4 and 5 | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. |
| Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Pre-booster vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) and Day 760b (Month 25b) in Parts 4 and 5 | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent), and four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) and at least trivalent (seropositive for ≥3 dengue serotypes), is derived from the titers of dengue-neutralizing antibodies. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. |
| VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | First half of Part 3 (18 months beginning at Month 22) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases due to virologically-confirmed dengue fever that occurred during the first half of Part 3. |
| Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype | Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 30b (Month 1b) in Part 4 | The GMR is the geometric mean of the ratio of the two visits being compared. |
| GMR of Neutralizing Antibodies for Each Dengue Serotype | Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 180b (Month 6b) in Part 4 | The GMR is the geometric mean of the ratio of the two visits being compared. |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) and Day 760b (Month 25b) in Parts 4 and 5 | GMTs of neutralizing antibodies were measured via MNT50. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. |
| VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | First half of Part 3 (18 months beginning at Month 22) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during the first half of Part 3. |
| VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4 | From 30 days post-booster vaccination (Day 30 booster [b] (Month 1b)) until the end of Part 4 (Month 13b) | The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b) | VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to. |
| VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever. |
| VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5 | From Month 14b until the end of Part 5 (Month 25b) | The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the any dengue serotype. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5 | From Month 14b until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted separately for each dengue serotype. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | From Month 14b until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | From Month 14b until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to. |
| VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5 | From Month 14b until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever. |
| VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype During Part 5 | From Month 14b until the end of Part 5 (Month 25b) | VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever. |
Countries
Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, Thailand
Participant flow
Recruitment details
Participants took part in the study at various investigative sites globally from 26 April 2016 to 28 June 2024.
Pre-assignment details
Healthy children and adolescents were randomized in a 2:1 ratio to receive either tetravalent dengue vaccine (TDV) or placebo followed by a booster vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study. | 6,317 |
| TDV 0.5 mL Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study. | 12,704 |
| Total | 19,021 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part 1: Vaccine Efficacy (Months 0-15) | Adverse Event | 5 | 14 |
| Part 1: Vaccine Efficacy (Months 0-15) | Lost to Follow-up | 13 | 26 |
| Part 1: Vaccine Efficacy (Months 0-15) | Pregnancy | 19 | 42 |
| Part 1: Vaccine Efficacy (Months 0-15) | Protocol Violation | 2 | 5 |
| Part 1: Vaccine Efficacy (Months 0-15) | Reason not Specified | 7 | 15 |
| Part 1: Vaccine Efficacy (Months 0-15) | Withdrawal by Participant and/or Participants Parent/Guardian | 131 | 260 |
| Part 1: Vaccine Efficacy (Months 0-15) | Without Adult Consent in Place | 1 | 4 |
| Part 2: Additional VE (Months 16-21) | Adverse Event | 0 | 1 |
| Part 2: Additional VE (Months 16-21) | Lost to Follow-up | 4 | 8 |
| Part 2: Additional VE (Months 16-21) | Pregnancy | 11 | 17 |
| Part 2: Additional VE (Months 16-21) | Reason Not Specified | 3 | 6 |
| Part 2: Additional VE (Months 16-21) | Withdrawal by Participant&/ortheir Parent/Guardian | 13 | 33 |
| Part 2: Additional VE (Months 16-21) | Without Adult Consent in Place | 1 | 7 |
| Part 3: Long Term Safety & VE (3 Years) | Adverse Event | 6 | 10 |
| Part 3: Long Term Safety & VE (3 Years) | Lost to Follow-up | 67 | 149 |
| Part 3: Long Term Safety & VE (3 Years) | Pregnancy | 120 | 228 |
| Part 3: Long Term Safety & VE (3 Years) | Protocol Violation | 1 | 2 |
| Part 3: Long Term Safety & VE (3 Years) | Reason Not Specified | 13 | 18 |
| Part 3: Long Term Safety & VE (3 Years) | Withdrawal by Participant and/or Participants Parent/Guardian | 119 | 227 |
| Part 3: Long Term Safety & VE (3 Years) | Without Adult Consent in Place | 82 | 150 |
| Part 4: Booster VE & Safety (13 Months) | Adverse Event | 1 | 3 |
| Part 4: Booster VE & Safety (13 Months) | Lost to Follow-up | 4 | 13 |
| Part 4: Booster VE & Safety (13 Months) | Pregnancy | 8 | 15 |
| Part 4: Booster VE & Safety (13 Months) | Reason Not Specified | 4 | 9 |
| Part 4: Booster VE & Safety (13 Months) | Withdrawal by Participant and/or Participants Parent/Guardian | 29 | 60 |
| Part 4: Booster VE & Safety (13 Months) | Without Adult Consent in Place | 0 | 1 |
| Part 5: Booster VE & Safety (1 Year) | Adverse Event | 0 | 3 |
| Part 5: Booster VE & Safety (1 Year) | Lost to Follow-up | 8 | 30 |
| Part 5: Booster VE & Safety (1 Year) | Pregnancy | 18 | 27 |
| Part 5: Booster VE & Safety (1 Year) | Reason Not Specified | 40 | 89 |
| Part 5: Booster VE & Safety (1 Year) | Withdrawal by Subject | 18 | 40 |
| Part 5: Booster VE & Safety (1 Year) | Without Adult Consent in Place | 14 | 29 |
Baseline characteristics
| Characteristic | TDV 0.5 mL | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 9.6 years STANDARD_DEVIATION 3.35 | 9.6 years STANDARD_DEVIATION 3.35 | 9.6 years STANDARD_DEVIATION 3.34 |
| Body Mass Index (BMI) | 17.76 kg/m^2 STANDARD_DEVIATION 3.831 | 17.73 kg/m^2 STANDARD_DEVIATION 3.77 | 17.67 kg/m^2 STANDARD_DEVIATION 3.645 |
| Height | 134.84 cm STANDARD_DEVIATION 19.151 | 134.85 cm STANDARD_DEVIATION 19.092 | 134.87 cm STANDARD_DEVIATION 18.976 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4821 Participants | 7200 Participants | 2379 Participants |
| Race/Ethnicity, Customized Asian | 5888 Participants | 8822 Participants | 2934 Participants |
| Race/Ethnicity, Customized Black or African American | 1353 Participants | 2061 Participants | 708 Participants |
| Race/Ethnicity, Customized More than one race or Unknown | 356 Participants | 520 Participants | 164 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 284 Participants | 415 Participants | 131 Participants |
| Region of Enrollment Brazil | 1091 Participants | 1595 Participants | 504 Participants |
| Region of Enrollment Colombia | 2268 Participants | 3423 Participants | 1155 Participants |
| Region of Enrollment Dominican Republic | 1007 Participants | 1540 Participants | 533 Participants |
| Region of Enrollment Nicaragua | 512 Participants | 751 Participants | 239 Participants |
| Region of Enrollment Panama | 1930 Participants | 2874 Participants | 944 Participants |
| Region of Enrollment Philippines | 2554 Participants | 3860 Participants | 1306 Participants |
| Region of Enrollment Sri Lanka | 1368 Participants | 2051 Participants | 683 Participants |
| Region of Enrollment Thailand | 1974 Participants | 2927 Participants | 953 Participants |
| Sex: Female, Male Female | 6314 Participants | 9412 Participants | 3098 Participants |
| Sex: Female, Male Male | 6390 Participants | 9609 Participants | 3219 Participants |
| Weight | 33.98 kg STANDARD_DEVIATION 14.951 | 33.91 kg STANDARD_DEVIATION 14.805 | 33.77 kg STANDARD_DEVIATION 14.506 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 6,687 | 22 / 13,380 | 7 / 6,519 | 18 / 13,033 | 7 / 6,487 | 17 / 12,961 | 1 / 2,985 | 6 / 5,990 | 0 / 2,939 | 3 / 5,889 |
| other Total, other adverse events | 527 / 6,687 | 1,260 / 13,380 | 0 / 6,519 | 0 / 13,033 | 0 / 6,487 | 0 / 12,961 | 149 / 2,985 | 409 / 5,990 | 0 / 2,939 | 0 / 5,889 |
| serious Total, serious adverse events | 256 / 6,687 | 414 / 13,380 | 82 / 6,519 | 152 / 13,033 | 397 / 6,487 | 666 / 12,961 | 126 / 2,985 | 161 / 5,990 | 73 / 2,939 | 109 / 5,889 |
Outcome results
Primary
Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1.
Time frame: 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 1 (Month 15) when at least 120 cases of dengue fever were confirmed and minimum duration of participant follow-up was 12 months post-second vaccination
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 149 number of cases |
| TDV 0.5 mL | Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 61 number of cases |
Comparison: Assuming true VE of 60% and, virologically confirmed cases of dengue fever induced by any dengue serotype occurring from 30 days post 2nd vaccination (Day 120) until end of Part 1 would provide at least 90% power to rule out vaccine effect of ≤25%.p-value: <0.00195% CI: [73.3, 85.3]Cox Proportional Hazard Model
Secondary
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
GMTs of neutralizing antibodies were measured via microneutralization test 50% (MNT50). The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
Population: PPSI: all participants in FASI who had no major protocol violations. The FASI were based on FAS \& included all randomized participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-3 | 105.3 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-2 | 197.2 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-4 | 84.4 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-3 | 103.9 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-1 | 139.2 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-4 | 80.8 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-2 | 211.8 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-4 | 77.8 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-3 | 97.3 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-3 | 108.6 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-4 | 99.9 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-1 | 139.0 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-1 | 161.3 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-3 | 109.4 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-2 | 183.1 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-2 | 215.3 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-3 | 111.0 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-4 | 77.6 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-4 | 98.6 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-3 | 114.5 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-1 | 205.1 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-1 | 127.5 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-2 | 208.1 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-4 | 86.2 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-3 | 127.5 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-1 | 126.3 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-4 | 110.4 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-1 | 130.5 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-1 | 213.3 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-2 | 197.4 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-2 | 193.6 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-2 | 225.7 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-3 | 139.8 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-2 | 201.0 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-4 | 107.6 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-1 | 128.6 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-4 | 244.4 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-1 | 120.3 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-2 | 186.0 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-3 | 108.7 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-4 | 76.2 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-1 | 1031.5 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-2 | 6575.7 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-3 | 1133.8 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-4 | 653.4 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-1 | 828.7 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-2 | 3598.5 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-3 | 714.2 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-4 | 463.9 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-1 | 1059.2 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-2 | 3646.7 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-3 | 986.7 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-4 | 630.0 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-1 | 666.6 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-2 | 2521.0 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-3 | 513.0 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-4 | 390.0 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-1 | 584.1 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-2 | 1977.3 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-3 | 383.9 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-4 | 408.0 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-1 | 567.8 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-2 | 1123.9 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-3 | 377.7 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-4 | 345.0 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-1 | 513.2 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-2 | 896.4 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-3 | 323.2 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-4 | 283.8 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-1 | 483.1 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-2 | 727.5 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-3 | 327.9 titres |
Secondary
Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Percentages were rounded off to the nearest single decimal place.
Time frame: Days 1 through 28 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)
Population: The SS-Immunogenicity Subset included all randomized participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). Number analyzed is the number of participants with data available for analysis for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset | After First Vaccination | 11.6 percentage of participants |
| Placebo | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset | After Second Vaccination | 9.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset | After First Vaccination | 11.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset | After Second Vaccination | 9.3 percentage of participants |
Secondary
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Time frame: First and Second half (18 months each) of Part 3 (up to 3 years, beginning at Month 22)
Population: The SS included all randomized participants who received at least one dose of the IP (TDV or placebo). Overall number of participants analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants at risk at the start of the specified analysis period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 | Fatal SAEs: Second Half of Part 3 | 0.0631 percentage of participants |
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 | SAEs Related to Study Drug: First Half of Part 3 | 0 percentage of participants |
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 | SAEs Related to Study Drug: Second Half of Part 3 | 0 percentage of participants |
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 | Fatal SAEs: First Half of Part 3 | 0.0308 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 | SAEs Related to Study Drug: Second Half of Part 3 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 | SAEs Related to Study Drug: First Half of Part 3 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 | Fatal SAEs: Second Half of Part 3 | 0.0474 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 | Fatal SAEs: First Half of Part 3 | 0.0386 percentage of participants |
Secondary
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. In the category 'Part 1 and 2 combined' participants are counted only once even if they experienced events in both Part 1 and Part 2 in order to yield total of unique participants who had SAEs.
Time frame: From Day 1 until the end of Parts 1 (Month 15) and 2 (Month 21)
Population: The SS included all randomized participants who received at least one dose of the investigational product (IP) (TDV or placebo). Number analyzed is the number of participants at risk at the start of the specified analysis period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2 | Part 1 | 3.8 percentage of participants |
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2 | Part 2 | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2 | Parts 1 and 2 Combined | 4.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2 | Part 1 | 3.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2 | Part 2 | 1.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2 | Parts 1 and 2 Combined | 4.1 percentage of participants |
Secondary
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Time frame: Days 1 through 7 after each vaccination
Population: The Safety Set (SS)- Immunogenicity Subset included all randomized participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). Number analyzed is the number of participants with data available for analyses for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Pain: Mild | 16.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Erythema; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Pain: Moderate | 2.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Pain: Moderate | 1.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Pain: Severe | 0.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Erythema; Mild | 0.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Erythema; Mild | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Pain: Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Erythema; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Swelling; Mild | 0.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Erythema; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Erythema; Mild | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Swelling; Mild | 0.4 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Pain: Severe | 0.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Swelling; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Erythema; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Swelling; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Swelling; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Pain; Mild | 10.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Erythema; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Pain; Moderate | 1.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Erythema; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Pain; Severe | 0.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Swelling; Mild | 0.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Erythema; Mild | 0.0898 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Swelling; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Erythema; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Swelling; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Erythema; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Pain: Moderate | 1.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Swelling; Mild | 0.0899 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Swelling; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Swelling; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Pain: Mild | 13.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Swelling; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Pain: Mild | 19.5 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Swelling; Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Pain: Mild | 21.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Pain: Moderate | 2.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Pain: Severe | 0.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Erythema; Mild | 0.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Erythema; Moderate | 0.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Erythema; Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Swelling; Mild | 1.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Swelling; Moderate | 0.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Swelling; Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Pain: Mild | 18.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Pain: Moderate | 2.5 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Pain: Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Erythema; Mild | 0.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Erythema; Moderate | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Erythema; Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Swelling; Mild | 0.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Swelling; Moderate | 0.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Swelling; Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Pain: Mild | 23.4 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Pain: Moderate | 3.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Pain: Severe | 0.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Erythema; Mild | 1.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Erythema; Moderate | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Erythema; Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Swelling; Mild | 1.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Swelling; Moderate | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Swelling; Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Pain; Mild | 19.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Pain; Moderate | 3.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Pain; Severe | 0.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Erythema; Mild | 0.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Erythema; Moderate | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Erythema; Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Swelling; Mild | 0.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination Swelling; Moderate | 0 percentage of participants |
Secondary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Solicited systemic AEs in children (\< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥ 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except fever) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for fever were derived from the recorded body temperature measurements and presented using the proposed temperature increments published by the Brighton Collaboration. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Time frame: Days 1 through 14 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)
Population: The SS- Immunogenicity Subset included all randomized participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). Number analyzed is the number of participants with data available for analysis for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Irritability/Fussiness: Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Irritability/Fussiness: Moderate | 0.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Irritability/Fussiness: Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Drowsiness; Mild | 10.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Drowsiness; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Drowsiness; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Loss of Appetite; Mild | 7.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Loss of Appetite; Moderate | 1.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Loss of Appetite; Severe | 0.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever; 38.0-<38.5 | 3.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever; 38.5-<39.0 | 2.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever; 39.0-<39.5 | 2.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever; 39.5-<40.0 | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever: >=40.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Irritability/Fussiness: Mild | 2.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Irritability/Fussiness: Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Irritability/Fussiness: Mild | 8.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Drowsiness; Mild | 4.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Drowsiness; Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Drowsiness; Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Loss of Appetite; Mild | 4.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Loss of Appetite; Moderate | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Loss of Appetite; Severe | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 38.0-<38.5 | 4.4 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 38.5-<39.0 | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 39.0-<39.5 | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 39.5-<40.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 40.0-<40.5 | 0.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: >=40.5 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Headache: Mild | 17.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Headache: Moderate | 3.4 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Headache: Severe | 1.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Asthenia: Mild | 8.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Asthenia: Moderate | 2.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Asthenia: Severe | 0.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Malaise: Mild | 11.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Malaise: Moderate | 2.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Malaise: Severe | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Muscle Pain: Mild | 11.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Muscle Pain: Moderate | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Muscle Pain: Severe | 0.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 38.0-<38.5 | 3.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 38.5-<39.0 | 1.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 39.0-<39.5 | 1.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 39.5-<40.0 | 0.4 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 40.0-<40.5 | 0.0951 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 40.5-<41.0 | 0.0951 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: >=41.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Headache: Mild | 10.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Headache: Moderate | 2.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Headache: Severe | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Asthenia: Mild | 5.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Asthenia: Moderate | 1.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Asthenia: Severe | 0.4 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Malaise: Mild | 6.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Malaise: Moderate | 1.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Malaise: Severe | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Muscle Pain: Mild | 7.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Muscle Pain: Moderate | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Muscle Pain: Severe | 0.4 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 38.0-<38.5 | 3.4 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 38.5-<39.0 | 1.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 39.0-<39.5 | 1.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 39.5-<40.0 | 0.4 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 40.0-<40.5 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: >=40.5 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Headache: Moderate | 3.5 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Irritability/Fussiness: Mild | 7.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Asthenia: Moderate | 2.8 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Irritability/Fussiness: Moderate | 0.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: >=40.5 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Irritability/Fussiness: Severe | 0.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Asthenia: Severe | 0.8 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Drowsiness; Mild | 8.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Headache: Severe | 1.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Drowsiness; Moderate | 2.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Malaise: Mild | 11.8 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Drowsiness; Severe | 0.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Muscle Pain: Moderate | 2.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Loss of Appetite; Mild | 12.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Malaise: Moderate | 3.4 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Loss of Appetite; Moderate | 1.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Asthenia: Mild | 6.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Loss of Appetite; Severe | 0.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Malaise: Severe | 1.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever; 38.0-<38.5 | 3.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 39.0-<39.5 | 0.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever; 38.5-<39.0 | 1.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Muscle Pain: Mild | 14.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever; 39.0-<39.5 | 1.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Asthenia: Moderate | 1.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever; 39.5-<40.0 | 1.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Muscle Pain: Moderate | 2.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After First Vaccination; Fever: >=40.0 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Muscle Pain: Severe | 0.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Irritability/Fussiness: Mild | 5.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Muscle Pain: Severe | 0.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Irritability/Fussiness: Moderate | 0.4 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Asthenia: Severe | 0.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Irritability/Fussiness: Severe | 0.4 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 38.0-<38.5 | 3.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Drowsiness; Mild | 6.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 40.0-<40.5 | 0.0467 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Drowsiness; Moderate | 1.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 38.5-<39.0 | 2.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Drowsiness; Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Malaise: Mild | 8.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Loss of Appetite; Mild | 6.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 39.0-<39.5 | 0.5 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Loss of Appetite; Moderate | 1.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 38.0-<38.5 | 2.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Loss of Appetite; Severe | 0.4 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 39.5-<40.0 | 0.4 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 38.0-<38.5 | 1.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Malaise: Moderate | 1.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 38.5-<39.0 | 3.5 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 40.0-<40.5 | 0.0479 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 39.0-<39.5 | 1.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 39.5-<40.0 | 0.5 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 39.5-<40.0 | 0.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: 40.5-<41.0 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: 40.0-<40.5 | 0.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Malaise: Severe | 1.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age <6 Years; After Second Vaccination; Fever: >=40.5 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Fever: >=41.0 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Headache: Mild | 17.5 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Fever: 38.5-<39.0 | 1.5 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Headache: Moderate | 5.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Headache: Mild | 10.4 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Headache: Severe | 1.8 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After Second Vaccination; Muscle Pain: Mild | 10.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset | Children of Age >=6 Years; After First Vaccination; Asthenia: Mild | 8.8 percentage of participants |
Secondary
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Time frame: Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
Population: Per-Protocol Set for Immunogenicity (PPSI): all participants in Full Analysis Set for Immunogenicity (FASI) who had no major protocol violations. The FASI were based on FAS \& included all randomized participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-3 | 65.0 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-1 | 65.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-2 | 70.3 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-3 | 63.7 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-4 | 63.2 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-1 | 65.0 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-2 | 70.0 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-3 | 64.0 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-4 | 62.7 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-1 | 66.9 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-2 | 71.2 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-3 | 63.6 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-4 | 63.6 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-1 | 67.6 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-2 | 71.8 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-4 | 65.2 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-1 | 67.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-2 | 73.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-3 | 65.2 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-4 | 65.2 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-1 | 67.7 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-2 | 70.4 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-3 | 64.3 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-4 | 66.0 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-1 | 69.6 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-2 | 72.0 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-3 | 67.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-4 | 68.6 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-1 | 71.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-2 | 73.7 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-3 | 68.8 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-4 | 70.7 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-1 | 72.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-2 | 73.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-3 | 70.2 percentage of participants |
| Placebo | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-4 | 71.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-4 | 98.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-3 | 99.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-2 | 99.912 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-3 | 98.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-1 | 64.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-4 | 98.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-2 | 69.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-4 | 99.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-3 | 63.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-4 | 96.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Baseline: DENV-4 | 63.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-1 | 97.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-1 | 98.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-1 | 95.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-2 | 99.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-2 | 99.955 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-3 | 98.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-1 | 94.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 1: DENV-4 | 97.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-3 | 97.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-1 | 97.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-2 | 99.948 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-2 | 99.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 15: DENV-4 | 98.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-3 | 98.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-3 | 95.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 3: DENV-4 | 97.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-1 | 97.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-1 | 99.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 2: DENV-3 | 95.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-2 | 99.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 4: DENV-4 | 99.912 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 3: DENV-2 | 99.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-1 | 98.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Year 1: DENV-3 | 97.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset | Month 9: DENV-2 | 100.0 percentage of participants |
Secondary
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent), and four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) and at least trivalent (seropositive for ≥3 dengue serotypes), is derived from the titers of dengue-neutralizing antibodies. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Time frame: Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
Population: PPSI: all participants in FASI who had no major protocol violations. The FASI were based on FAS \& included all randomized participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: Tetravalent | 62.7 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: Trivalent | 3.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: At Least Bivalent | 68.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: At Least Bivalent | 66.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: At Least Trivalent | 64.7 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: Tetravalent | 60.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: Monovalent | 3.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: Trivalent | 3.2 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: Bivalent | 3.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: At Least Bivalent | 67.0 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: Trivalent | 2.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: Bivalent | 3.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: Tetravalent | 62.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: At Least Trivalent | 63.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: At Least Bivalent | 68.4 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: Tetravalent | 59.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: At Least Trivalent | 64.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: Monovalent | 6.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: Monovalent | 3.5 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: At Least Trivalent | 63.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: Bivalent | 1.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: Bivalent | 2.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: Trivalent | 2.2 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: At Least Bivalent | 65.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: Tetravalent | 65.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: Trivalent | 2.5 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: At Least Bivalent | 70.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: Tetravalent | 60.4 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: At Least Trivalent | 68.2 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: Tetravalent | 62.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: Monovalent | 2.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: At Least Trivalent | 63.0 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: Bivalent | 2.5 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: At Least Bivalent | 67.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: Trivalent | 1.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: Monovalent | 7.4 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: Tetravalent | 67.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: At Least Trivalent | 65.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: At Least Bivalent | 72.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: Monovalent | 6.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: At Least Trivalent | 69.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: Monovalent | 7.7 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:Monovalent | 2.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: Trivalent | 2.7 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3: Bivalent | 1.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: Bivalent | 3.4 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:Trivalent | 2.5 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: Bivalent | 3.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:Tetravalent | 68.3 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: Trivalent | 2.0 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:At Least Bivalent | 72.7 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: Bivalent | 2.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:At Least Trivalent | 70.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: Monovalent | 5.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:At Least Trivalent | 95.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: Monovalent | 6.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: Bivalent | 2.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: Trivalent | 2.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: Tetravalent | 60.2 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: At Least Bivalent | 65.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Baseline: At Least Trivalent | 63.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: Monovalent | 0.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: Bivalent | 0.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: Trivalent | 3.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: Tetravalent | 95.2 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: At Least Bivalent | 99.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 1: At Least Trivalent | 98.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: Monovalent | 0.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: Bivalent | 1.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: Trivalent | 3.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: Tetravalent | 94.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: At Least Bivalent | 99.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 3: At Least Trivalent | 98.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: Monovalent | 0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: Bivalent | 0.088 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: Trivalent | 0.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: Tetravalent | 99.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: At Least Bivalent | 99.956 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 4: At Least Trivalent | 99.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: Monovalent | 0.091 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: Bivalent | 0.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: Trivalent | 2.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: Tetravalent | 97.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: At Least Bivalent | 99.909 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 9: At Least Trivalent | 99.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: Monovalent | 0.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: Bivalent | 1.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: Trivalent | 2.2 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: Tetravalent | 96.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: At Least Bivalent | 99.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Month 15: At Least Trivalent | 98.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: Monovalent | 0.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: Bivalent | 1.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: Trivalent | 2.2 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: Tetravalent | 95.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: At Least Bivalent | 99.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 1: At Least Trivalent | 97.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: Monovalent | 1.1 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: Bivalent | 1.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: Trivalent | 3.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: Tetravalent | 93.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: At Least Bivalent | 98.9 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 2: At Least Trivalent | 97.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:Monovalent | 1.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3: Bivalent | 2.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:Trivalent | 3.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:Tetravalent | 92.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset | Year 3:At Least Bivalent | 98.3 percentage of participants |
Secondary
VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2.
Time frame: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 66 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 13 number of cases |
p-value: <0.00195% CI: [82.6, 94.7]Cox Proportional Hazard Model
Secondary
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2.
Time frame: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with seronegative baseline status and with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline | 56 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline | 39 number of cases |
95% CI: [49.1, 77.5]Cox Proportional Hazard Model
Secondary
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2.
Time frame: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with seropositive baseline status and with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline | 150 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline | 75 number of cases |
95% CI: [68.5, 81.9]Cox Proportional Hazard Model
Secondary
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2.
Time frame: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype | DENV-1 | 62 number of cases |
| Placebo | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype | DENV-2 | 80 number of cases |
| Placebo | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype | DENV-3 | 60 number of cases |
| Placebo | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype | DENV-4 | 5 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype | DENV-4 | 5 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype | DENV-1 | 38 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype | DENV-3 | 63 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype | DENV-2 | 8 number of cases |
Comparison: DENV-195% CI: [54.8, 79.9]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [89.9, 97.6]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [27.1, 64.1]Cox Proportional Hazard Model
Comparison: DENV-495% CI: [-69.7, 85.8]Cox Proportional Hazard Model
Secondary
VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2.
Time frame: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype | 1 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype | 2 number of cases |
95% CI: [-978.5, 91.1]Cox Proportional Hazard Model
Other Pre-specified
Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype
The GMR is the geometric mean of the ratio of the two visits being compared.
Time frame: Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 30b (Month 1b) in Part 4
Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analyses for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype | DENV-1 | 0.9 unitless ratio |
| Placebo | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype | DENV-2 | 0.9 unitless ratio |
| Placebo | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype | DENV-3 | 1.1 unitless ratio |
| Placebo | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype | DENV-4 | 0.9 unitless ratio |
| TDV 0.5 mL | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype | DENV-4 | 3.5 unitless ratio |
| TDV 0.5 mL | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype | DENV-1 | 3.1 unitless ratio |
| TDV 0.5 mL | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype | DENV-3 | 4.3 unitless ratio |
| TDV 0.5 mL | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype | DENV-2 | 2.4 unitless ratio |
Other Pre-specified
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
GMTs of neutralizing antibodies were measured via MNT50. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) and Day 760b (Month 25b) in Parts 4 and 5
Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Number analyzed: number of participants with data available for analyses for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Day 1b: DENV-1 | 172.7 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Day 1b: DENV-2 | 164.5 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Day 1b: DENV-3 | 129.4 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Day 1b: DENV-4 | 81.5 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 1b: DENV-1 | 179.8 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 1b: DENV-2 | 174.8 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 1b: DENV-3 | 159.9 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 1b: DENV-4 | 87.3 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 6b: DENV-1 | 191.5 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 6b: DENV-2 | 208.0 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 6b: DENV-3 | 156.0 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 6b: DENV-4 | 86.4 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 13b: DENV-1 | 259.3 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 13b: DENV-2 | 248.9 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 13b: DENV-3 | 199.1 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 13b: DENV-4 | 115.0 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 25b: DENV-1 | 293.8 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 25b: DENV-2 | 278.5 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 25b: DENV-3 | 229.7 titres |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 25b: DENV-4 | 129.2 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 25b: DENV-2 | 951.6 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Day 1b: DENV-1 | 374.7 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 6b: DENV-3 | 851.0 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Day 1b: DENV-2 | 609.4 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 13b: DENV-4 | 433.1 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Day 1b: DENV-3 | 305.2 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 6b: DENV-4 | 457.6 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Day 1b: DENV-4 | 172.9 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 25b: DENV-4 | 387.9 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 1b: DENV-1 | 1493.8 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 13b: DENV-1 | 949.1 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 1b: DENV-2 | 1611.5 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 25b: DENV-1 | 865.6 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 1b: DENV-3 | 1546.6 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 13b: DENV-2 | 1003.2 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 1b: DENV-4 | 793.8 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 25b: DENV-3 | 688.3 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 6b: DENV-1 | 1000.9 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 13b: DENV-3 | 804.1 titres |
| TDV 0.5 mL | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5 | Month 6b: DENV-2 | 1167.2 titres |
Other Pre-specified
GMR of Neutralizing Antibodies for Each Dengue Serotype
The geometric mean ratio is the geometric mean of the ratio of the two visits being compared.
Time frame: Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 720b (Month 25b) in Part 5
Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analyses for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-1 | 1.3 unitless ratio |
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-2 | 1.3 unitless ratio |
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-3 | 1.4 unitless ratio |
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-4 | 1.3 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-4 | 1.9 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-1 | 2.0 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-3 | 2.1 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-2 | 1.6 unitless ratio |
Other Pre-specified
GMR of Neutralizing Antibodies for Each Dengue Serotype
The geometric mean ratio is the geometric mean of the ratio of the two visits being compared.
Time frame: Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 395b (Month 13b) in Part 4
Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analyses for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-1 | 1.3 unitless ratio |
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-2 | 1.3 unitless ratio |
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-3 | 1.3 unitless ratio |
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-4 | 1.3 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-4 | 2.0 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-1 | 2.1 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-3 | 2.4 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-2 | 1.6 unitless ratio |
Other Pre-specified
GMR of Neutralizing Antibodies for Each Dengue Serotype
The GMR is the geometric mean of the ratio of the two visits being compared.
Time frame: Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 180b (Month 6b) in Part 4
Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analyses for specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-1 | 1.0 unitless ratio |
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-2 | 1.1 unitless ratio |
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-3 | 1.0 unitless ratio |
| Placebo | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-4 | 0.9 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-4 | 2.1 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-1 | 2.2 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-3 | 2.5 unitless ratio |
| TDV 0.5 mL | GMR of Neutralizing Antibodies for Each Dengue Serotype | DENV-2 | 1.8 unitless ratio |
Other Pre-specified
Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Percentages were rounded off to the nearest single decimal place.
Time frame: Days 1b through 28b after booster vaccination in Part 4
Population: Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4 | 1.8 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4 | 1.8 percentage of participants |
Other Pre-specified
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. In the category 'Part 4 and 5 combined' participants are counted only once even if they experienced events in both Part 4 and Part 5 in order to yield total of unique participants who had SAEs.
Time frame: From Day 1b until the end of Part 4 (Month 13b) and Part 5 (Month 25b)
Population: SS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Number analyzed is the number of participants at risk at the start of the specified analysis period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Part 4: Fatal SAEs | 0.0335 percentage of participants |
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Part 4: SAEs Related to Study Drug | 0 percentage of participants |
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Part 5: Fatal SAEs | 0 percentage of participants |
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Part 5: SAEs Related to Study Drug | 0 percentage of participants |
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Parts 4&5 Combined: Fatal SAEs | 0.0335 percentage of participants |
| Placebo | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Parts 4&5 Combined: SAEs Related to Study Drug | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Parts 4&5 Combined: Fatal SAEs | 0.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Part 4: Fatal SAEs | 0.0501 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Part 5: SAEs Related to Study Drug | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Part 4: SAEs Related to Study Drug | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Parts 4&5 Combined: SAEs Related to Study Drug | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5 | Part 5: Fatal SAEs | 0.0509 percentage of participants |
Other Pre-specified
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. In the category 'Part 4 and 5 combined' participants are counted only once even if they experienced events in both Part 4 and Part 5 in order to yield total of unique participants who had SAEs.
Time frame: From Day 1b until the end of Part 4 (Month 13b) and Part 5 (Month 25b)
Population: Safety Set-Booster (SS-B) included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Number analyzed is the number of participants at risk at the start of the specified analysis period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5 | Part 4 | 4.2 percentage of participants |
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5 | Part 5 | 2.5 percentage of participants |
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5 | Parts 4 and 5 Combined | 6.4 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5 | Part 4 | 2.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5 | Part 5 | 1.9 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5 | Parts 4 and 5 Combined | 4.4 percentage of participants |
Other Pre-specified
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place.
Time frame: Days 1b through 7b after booster vaccination in Part 4
Population: Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset. Number analyzed is the number of participants with data available for analyses for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Pain: Moderate | 3.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Erythema: Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Erythema: Mild | 0.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Swelling: Mild | 0.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Pain: Severe | 0.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Swelling: Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Erythema: Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Swelling: Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Pain: Mild | 12.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Swelling: Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Pain: Mild | 20.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Pain: Moderate | 4.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Pain: Severe | 1.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Erythema: Mild | 1.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Erythema: Moderate | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Erythema: Severe | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Swelling: Mild | 1.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Swelling: Moderate | 0 percentage of participants |
Other Pre-specified
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except fever) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for fever were derived from the recorded body temperature measurements and presented using the proposed temperature increments published by the Brighton Collaboration. Percentages were rounded off to the nearest single decimal place except the data point where rounding-up may lead to data misinterpretation.
Time frame: Days 1b through 14b after booster vaccination in Part 4
Population: Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset. Number analyzed is the number of participants with data available for analyses for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Asthenia: Severe | 0.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Myalgia: Moderate | 1.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Asthenia: Mild | 7.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Myalgia: Severe | 1.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Malaise: Mild | 7.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 38.0-<38.5 | 1.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Headache: Severe | 0.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 38.5-<39.0 | 0.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Malaise: Moderate | 2.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 39.0-<39.5 | 0.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Asthenia: Moderate | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 39.5-<40.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Malaise: Severe | 0.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 40.0-<40.5 | 0.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Headache: Moderate | 4.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 40.5-<41.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Myalgia: Mild | 9.9 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: >=41.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Headache: Mild | 8.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: >=41.0 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Headache: Mild | 12.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Headache: Moderate | 3.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Headache: Severe | 1.1 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Asthenia: Mild | 7.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Asthenia: Moderate | 2.4 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Asthenia: Severe | 0.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Malaise: Mild | 8.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Malaise: Moderate | 2.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Malaise: Severe | 0.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Myalgia: Mild | 11.7 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Myalgia: Moderate | 3.6 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Myalgia: Severe | 0.8 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 38.0-<38.5 | 1.8 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 38.5-<39.0 | 1.0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 39.0-<39.5 | 0.2 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 39.5-<40.0 | 0.3 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 40.0-<40.5 | 0 percentage of participants |
| TDV 0.5 mL | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4 | Fever: 40.5-<41.0 | 0.0873 percentage of participants |
Other Pre-specified
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Time frame: Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) and Day 760b (Month 25b) in Parts 4 and 5
Population: Per-Protocol Set for Immunogenicity-Booster (PPSI-B):all participants in Full Analysis Set for Immunogenicity-Booster (FASI-B) who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Number analyzed: participants with data available for analyses for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Day 1b: DENV-3 | 69.0 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 6b: DENV-3 | 73.0 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 1b: DENV-2 | 74.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 6b: DENV-4 | 70.3 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Day 1b: DENV-2 | 72.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 13b: DENV-1 | 74.5 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 1b: DENV-3 | 72.9 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Day 1b: DENV-4 | 67.0 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 13b: DENV-3 | 74.9 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 1b: DENV-4 | 69.2 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 13b: DENV-4 | 72.4 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Day 1b: DENV-1 | 70.2 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 25b: DENV-1 | 77.2 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 6b: DENV-1 | 72.8 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 25b: DENV-2 | 78.6 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 1b: DENV-1 | 71.6 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 25b: DENV-3 | 77.7 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 6b: DENV-2 | 75.8 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 25b: DENV-4 | 76.3 percentage of participants |
| Placebo | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 13b: DENV-2 | 77.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 25b: DENV-4 | 99.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Day 1b: DENV-1 | 94.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Day 1b: DENV-2 | 99.2 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Day 1b: DENV-3 | 97.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Day 1b: DENV-4 | 93.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 1b: DENV-1 | 99.907 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 1b: DENV-2 | 99.907 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 1b: DENV-3 | 100.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 1b: DENV-4 | 99.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 6b: DENV-1 | 99.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 6b: DENV-2 | 99.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 6b: DENV-3 | 99.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 6b: DENV-4 | 99.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 13b: DENV-1 | 99.911 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 13b: DENV-2 | 99.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 13b: DENV-3 | 100.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 13b: DENV-4 | 99.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 25b: DENV-1 | 99.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 25b: DENV-2 | 99.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5 | Month 25b: DENV-3 | 99.909 percentage of participants |
Other Pre-specified
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent), and four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) and at least trivalent (seropositive for ≥3 dengue serotypes), is derived from the titers of dengue-neutralizing antibodies. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Time frame: Pre-booster vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) and Day 760b (Month 25b) in Parts 4 and 5
Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Number analyzed: number of participants with data available for analyses for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b: Tetravalent | 67.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b: Trivalent | 3.7 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b:At Least Bivalent | 73.3 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: Bivalent | 2.0 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b:At Least Trivalent | 70.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b: Tetravalent | 66.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: Monovalent | 6.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: At Least Trivalent | 67.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: Bivalent | 2.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b:At Least Bivalent | 72.3 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: Trivalent | 2.7 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: Tetravalent | 65.5 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: Tetravalent | 70.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b:At Least Trivalent | 70.3 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: At Least Bivalent | 74.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b: Monovalent | 6.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: At Least Trivalent | 72.7 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b:Monovalent | 6.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: Monovalent | 3.4 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: Trivalent | 2.3 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: Bivalent | 1.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b: Bivalent | 2.5 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: Trivalent | 1.6 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b: Bivalent | 2.0 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: Tetravalent | 74.5 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b: Trivalent | 3.2 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: At Least Bivalent | 77.9 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: At Least Bivalent | 69.8 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: At Least Trivalent | 76.1 percentage of participants |
| Placebo | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: Monovalent | 5.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: At Least Trivalent | 99.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: Monovalent | 1.3 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: Bivalent | 3.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: Trivalent | 4.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: Tetravalent | 90.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: At Least Bivalent | 98.7 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Day 1b: At Least Trivalent | 95.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b: Monovalent | 0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b: Bivalent | 0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b: Trivalent | 0.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b: Tetravalent | 99.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b:At Least Bivalent | 100.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 1b:At Least Trivalent | 100.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b:Monovalent | 0.0887 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b: Bivalent | 0.0887 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b: Trivalent | 0.6 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b: Tetravalent | 99.2 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b:At Least Bivalent | 99.911 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 6b:At Least Trivalent | 99.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: Monovalent | 0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: Bivalent | 0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: Trivalent | 0.8 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: Tetravalent | 99.2 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: At Least Bivalent | 100.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 13b: At Least Trivalent | 100.0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: Monovalent | 0 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: Bivalent | 0.0907 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: Trivalent | 0.4 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: Tetravalent | 99.5 percentage of participants |
| TDV 0.5 mL | Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5 | Month 25b: At Least Bivalent | 99.909 percentage of participants |
Other Pre-specified
VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever.
Time frame: From Month 14b until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5 | 13 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5 | 4 number of cases |
95% CI: [53.7, 95.1]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined | 37 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined | 7 number of cases |
95% CI: [78.8, 95.8]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | 24 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | 3 number of cases |
95% CI: [79.3, 98.1]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to.
Time frame: From Month 14b until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seronegative baseline status and with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | DENV-1 | 7 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | DENV-3 | 4 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | DENV-2 | 5 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | DENV-4 | 4 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | Any Dengue Serotype | 20 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | DENV-4 | 0 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | Any Dengue Serotype | 12 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | DENV-1 | 6 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | DENV-2 | 1 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5 | DENV-3 | 5 number of cases |
Comparison: Any Dengue Serotype95% CI: [39.1, 85.5]Cox Proportional Hazard Model
Comparison: DENV-195% CI: [-27.2, 85.7]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [14, 98.8]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [-138.1, 82.9]Cox Proportional Hazard Model
Comparison: DENV-495% CI: [43.1, 100]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seronegative baseline status and with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | DENV-1 | 21 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | DENV-3 | 6 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | DENV-2 | 10 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | DENV-4 | 9 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | Any Dengue Serotype | 46 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | DENV-4 | 4 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | Any Dengue Serotype | 23 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | DENV-1 | 10 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | DENV-2 | 2 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined | DENV-3 | 7 number of cases |
Comparison: Any Dengue Serotype95% CI: [59.3, 85]Cox Proportional Hazard Model
Comparison: DENV-195% CI: [50, 88.9]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [53.7, 97.8]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [-84.9, 79.2]Cox Proportional Hazard Model
Comparison: DENV-495% CI: [29.7, 93.3]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seronegative baseline status and with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-1 | 14 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-3 | 2 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-2 | 5 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-4 | 5 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | Any Dengue Serotype | 26 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-4 | 4 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | Any Dengue Serotype | 11 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-1 | 4 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-2 | 1 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-3 | 2 number of cases |
Comparison: Any Dengue Serotype95% CI: [57.8, 89.7]Cox Proportional Hazard Model
Comparison: DENV-195% CI: [57.6, 95.4]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [13.5, 98.8]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [-307.5, 92]Cox Proportional Hazard Model
Comparison: DENV-495% CI: [-45.1, 89.5]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to.
Time frame: From Month 14b until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seropositive baseline status and with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | DENV-1 | 12 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | DENV-3 | 16 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | DENV-2 | 13 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | DENV-4 | 6 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | Any Dengue Serotype | 46 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | DENV-4 | 3 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | Any Dengue Serotype | 33 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | DENV-1 | 11 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | DENV-2 | 4 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5 | DENV-3 | 15 number of cases |
Comparison: Any Dengue Serotype95% CI: [46.4, 78.1]Cox Proportional Hazard Model
Comparison: DENV-195% CI: [0.8, 80.7]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [54.4, 95.2]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [8.3, 77.6]Cox Proportional Hazard Model
95% CI: [2.2, 93.9]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seropositive baseline status and with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | DENV-1 | 30 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | DENV-3 | 19 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | DENV-2 | 39 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | DENV-4 | 27 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | Any Dengue Serotype | 113 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | DENV-4 | 11 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | Any Dengue Serotype | 61 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | DENV-1 | 22 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | DENV-2 | 12 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined | DENV-3 | 16 number of cases |
Comparison: Any Dengue Serotype95% CI: [64.4, 80.9]Cox Proportional Hazard Model
Comparison: DENV-195% CI: [37.8, 79.3]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [71.1, 92.1]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [18.5, 78.5]Cox Proportional Hazard Model
95% CI: [59.1, 89.9]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the Any Dengue Serotype category but counted separately for each dengue serotype they belong to.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seropositive baseline status and with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-1 | 18 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-3 | 2 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-2 | 26 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-4 | 21 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | Any Dengue Serotype | 67 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-4 | 8 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | Any Dengue Serotype | 28 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-1 | 11 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-2 | 8 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-3 | 1 number of cases |
Comparison: Any Dengue Serotype95% CI: [68.3, 86.9]Cox Proportional Hazard Model
Comparison: DENV-195% CI: [36.4, 85.8]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [66.6, 93.2]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [-168.8, 97.8]Cox Proportional Hazard Model
95% CI: [57.2, 91.6]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the any dengue serotype.
Time frame: From Month 14b until the end of Part 5 (Month 25b)
Population: The Per-Protocol Set-Booster (PPS-B) included all participants in the FAS-B who had no major protocol violations. The Full Analysis Set-Booster (FAS-B) included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5 | 66 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5 | 45 number of cases |
95% CI: [52.1, 77.5]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b) until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined | 159 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined | 84 number of cases |
95% CI: [66.6, 80.3]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases.
Time frame: From 30 days post-booster vaccination (Day 30 booster [b] (Month 1b)) until the end of Part 4 (Month 13b)
Population: The Per-Protocol Set-Booster (PPS-B) included all participants in the FAS-B who had no major protocol violations. The Full Analysis Set-Booster (FAS-B) included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4 | 93 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4 | 39 number of cases |
95% CI: [70.1, 85.9]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted separately for each dengue serotype.
Time frame: From Month 14b until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5 | DENV-1 | 19 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5 | DENV-2 | 18 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5 | DENV-3 | 20 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5 | DENV-4 | 10 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5 | DENV-4 | 3 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5 | DENV-1 | 17 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5 | DENV-3 | 20 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5 | DENV-2 | 5 number of cases |
Comparison: DENV-195% CI: [16.2, 77.4]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [63.8, 95]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [9.9, 73.9]Cox Proportional Hazard Model
Comparison: DENV-495% CI: [47.4, 96]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined | DENV-1 | 51 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined | DENV-2 | 49 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined | DENV-3 | 25 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined | DENV-4 | 36 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined | DENV-4 | 15 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined | DENV-1 | 32 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined | DENV-3 | 23 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined | DENV-2 | 14 number of cases |
Comparison: DENV-195% CI: [51.7, 80]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [74.5, 92.2]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [19.1, 73.9]Cox Proportional Hazard Model
Comparison: DENV-495% CI: [62.4, 88.7]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-1 | 32 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-2 | 31 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-3 | 4 number of cases |
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-4 | 26 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-4 | 12 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-1 | 15 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-3 | 3 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | DENV-2 | 9 number of cases |
Comparison: DENV-195% CI: [57.1, 87.4]Cox Proportional Hazard Model
Comparison: DENV-295% CI: [69.9, 93.2]Cox Proportional Hazard Model
Comparison: DENV-395% CI: [-69.7, 91.5]Cox Proportional Hazard Model
Comparison: DENV-495% CI: [54.8, 88.5]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype During Part 5
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever.
Time frame: From Month 14b until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype During Part 5 | 0 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype During Part 5 | 0 number of cases |
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined | 1 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined | 0 number of cases |
95% CI: [-849.4, 100]Cox Proportional Hazard Model
Other Pre-specified
VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever.
Time frame: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)
Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | 1 number of cases |
| TDV 0.5 mL | VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4 | 0 number of cases |
95% CI: [-849.4, 100]Cox Proportional Hazard Model
Other Pre-specified
VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during the second half of Part 3.
Time frame: Second half of Part 3 (18 months beginning at Month 40)
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 15 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 2 number of cases |
95% CI: [72.4, 98.6]Cox Proportional Hazard Model
Other Pre-specified
VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during the first half of Part 3.
Time frame: First half of Part 3 (18 months beginning at Month 22)
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 43 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 24 number of cases |
95% CI: [56.3, 83.9]Cox Proportional Hazard Model
Other Pre-specified
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases due to virologically-confirmed dengue fever that occurred during the second half of Part 3.
Time frame: Second half of Part 3 (18 months beginning at Month 40)
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 52 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 49 number of cases |
95% CI: [34.5, 70]Cox Proportional Hazard Model
Other Pre-specified
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases due to virologically-confirmed dengue fever that occurred during the first half of Part 3.
Time frame: First half of Part 3 (18 months beginning at Month 22)
Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 228 number of cases |
| TDV 0.5 mL | VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype | 252 number of cases |
95% CI: [37.1, 56]Cox Proportional Hazard Model