Dengue Fever, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Dengavaxia®
Brief summary
The aim of the study was to investigate the immunogenicity and safety of CYD dengue vaccine and Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine when both vaccines were administered concomitantly or sequentially. Primary Objectives: * To demonstrate the non-inferiority of the humoral immune response to the Tdap booster dose concomitantly administered with the first dose of CYD dengue vaccine as compared to sequential administration, measured 28 days after Tdap booster dose. * To demonstrate the non-inferiority of the humoral immune response to the first dose of CYD dengue vaccine concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the first dose of CYD dengue vaccine. Secondary Objectives: * To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD dengue vaccine with the first dose concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the third dose of CYD dengue vaccine. * To describe the humoral immune response at baseline and 28 days after the first and third doses of CYD dengue vaccine, in each and any group. * To describe the humoral immune response of Tdap vaccine at baseline and 28 days after concomitant administration with the first dose of CYD dengue vaccine as compared to the sequential administration, in each and any group. * To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each and any injection in each group.
Detailed description
Participants were to receive CYD dengue vaccine according to a 3-dose schedule administered 6 months apart, with the first dose of CYD dengue vaccine administered either concomitantly or sequentially with a booster dose of the Tdap vaccine, Adacel®. During the conduct of the study, a safety signal was identified which led to the Independent Data Monitoring Committee (IDMC) recommendation not to vaccinate participants who had never been infected by dengue prior to the first injection, i.e., dengue non-immune participants. The protocol was amended accordingly but never implemented due to absence of response of Health Authorities (HA) from The Philippines. After having waited for more than 1.5 years, and as the participants became out of window to complete their immunization schedule and the last safety follow-up call (6 months after the last dose), the Sponsor decided to stop the trial. Participants only attended a last safety follow-up visit to terminate the study and were informed about the end of the study. As a consequence, the study was prematurely terminated before injection of the last dose (3rd dose) of the CYD dengue vaccine. As a consequence of the IDMC recommendations, the main immunogenicity analyses were done in dengue immune participants which is not what was planned in the protocol (and this is why the primary endpoints are not exactly the same as those defined in the protocol as they were finally assessed only in dengue immune participants whereas initially it was planned to be assessed regardless of baseline status). All participants were assessed for immunogenicity and safety. Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.
Interventions
BIOLOGICALCYD Dengue Vaccine
0.5 milliliter (mL), Subcutaneous at Month 1, 7 and Month 13, respectively
0.5 mL, intramuscularly (IM) at Month 1.
0.5 mL, intramuscularly at Day 0.
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant aged 9 to 60 years (i.e., from the day of the 9th birthday to the day prior to the 61th birthday) on the day of inclusion. * Participant in good health, based on medical history and physical examination. * Informed consent form (ICF) or assent form was signed and dated by the participant (based on local regulations), and/or ICF was signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations). * For participant aged 9 to 11 years: known (documented) receipt of at least 4 previous doses of diphtheria toxoid, tetanus toxoid and acellular pertussis-containing (DTaP) vaccines, with the last dose not within the last 5 years prior to enrolment. OR For participant aged at least 12 years: known (documented or self-reported) receipt of at least 3 previous doses of diphtheria toxoid, tetanus toxoid, and whole cell pertussis-containing (DTwP) vaccines, with the last dose not within the last 5 years prior to enrolment. * Participant (or participant and parent\[s\]/legally acceptable representatives) was able to attend all scheduled visits and complied with all trial procedures.
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination). * Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Planned receipt of any vaccine in the 4 weeks following any trial vaccination. * Previous vaccination against dengue disease with the trial CYD dengue vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response. * Known or suspected congenital or acquired immunodeficiency (including human immunodeficiency virus (HIV) infection with impaired immune function); or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine. * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances. * Thrombocytopenia, contraindicating IM vaccination. * Bleeding disorder or receipt of anticoagulants within 3 weeks preceding inclusion, which might be a contraindication for IM vaccination, at the discretion of the Investigator. * Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction that, based on Investigator's judgment, may interfere with the participant's ability to comply with trial procedures. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion. * Identified as an Investigator or employee of the Investigator with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. * Self-reported HIV, Hepatitis B, or Hepatitis C infection. * Personal history of Guillain-Barré syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants | 28 days after Tdap vaccination | GMCs against each pertussis antigens (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], fimbriae types 2 and 3 \[FIM2+3\]) were assessed using an enzyme-linked immunosorbent assay (ELISA) method and were measured in ELISA unit/milliliter (EU/mL). Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. |
| Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | 28 days after Tdap vaccination | Seroprotection against diphtheria (Anti-D) and tetanus (Anti-T) antigens was performed by Micrometabolic Inhibition Test - Toxin Neutralization assay (MIT-TNA) and ELISA, respectively. Seroprotection was defined as anti-D and anti-T Ab concentration greater than 0.1 international units (IU)/mL. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. |
| Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | 28 days after first CYD dengue vaccination | The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Baseline (Pre-Tdap vaccination) and 28 days after the Tdap vaccination | GMCs against each pertussis antigens (PT, FHA, PRN, FIM2+3) were assessed using ELISA assay method and were measured in EU/mL. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. |
| Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Baseline (Pre-Tdap vaccination) and 28 days after the dose of Tdap vaccination | The GMC against diphtheria and tetanus antigens was performed by MIT-TNA and ELISA, respectively. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. |
| Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine | Within 30 minutes after any and each vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Any unsolicited AE occurred during first 30 minutes post-vaccination was recorded on the CRF as immediate AE. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccination and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination. |
| Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Within 7 days after any and each vaccination | A solicited reaction (SR) was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema, and swelling. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination. |
| Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination | The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution. |
| Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine | Within 28 days after any and each vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination. |
| Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine | Within 7 days post any and each vaccination | Non-serious AESIs were non-serious AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination. |
| Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine | From Day 0 up to 6 months after the last Tdap or CYD vaccination | SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; required hospitalization or prolonged existing hospitalization; persistent or significant disability/incapacity; congenital anomaly or a medically important event. Serious AESIs were SAEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. |
| Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Tdap or CYD Dengue Vaccine | From Day 0 up to 6 months after the last Tdap or CYD vaccination | Hospitalized suspected dengue case was defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned acute blood sample (within the first 5 days after fever onset) was collected for virological confirmation of hospitalized suspected dengue case. A suspected case was considered VCD if there was a detection of wild type dengue virus by dengue non-structural protein 1 antigen ELISA and/or dengue reverse transcriptase-polymerase chain reactions. |
| Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Within 14 days after any and each vaccination | A SR reaction was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited injection site reactions included fever, headache, malaise, myalgia, and asthenia. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination. |
| Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination | The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. |
| Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination | Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (1, 2, 3, and 4) were measured by PRNT50. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (\>=10 and \>=100 \[1/dilution\]) against at least 1, 2, 3, or 4 serotypes of CYD were reported. Here, 'dil'=dilution and vac=vaccination in the specified categories. |
Countries
Philippines
Participant flow
Recruitment details
Study participants were enrolled from 19 December 2016 to 17 April 2017 at 4 centers in the Philippines. A total of 688 participants were enrolled and randomized in this study.
Pre-assignment details
Safety signal was spotted in dengue non-immune participants, which led to IDMC suggestion to not vaccinate them anymore. As no Health Authority feedback was received on amendment, study was terminated before 3rd (last) injection of CYD dengue vaccine. Hence, no participants received 3rd CYD dengue dose (as planned) and all were followed for safety.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7. | 346 |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7. | 342 |
| Total | 688 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 27 | 22 |
| Overall Study | Non-compliance with the protocol | 308 | 308 |
| Overall Study | Withdrawal by Subject | 11 | 12 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Total | CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) |
|---|---|---|---|
| Age, Continuous | 27.1 years STANDARD_DEVIATION 16.7 | 26.6 years STANDARD_DEVIATION 16.5 | 26.2 years STANDARD_DEVIATION 16.3 |
| Dengue Baseline Status Dengue immune | 315 Participants | 629 Participants | 314 Participants |
| Dengue Baseline Status Dengue non-immune | 27 Participants | 59 Participants | 32 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 193 Participants | 380 Participants | 187 Participants |
| Sex: Female, Male Male | 149 Participants | 308 Participants | 159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 338 | 0 / 342 |
| other Total, other adverse events | 248 / 338 | 263 / 342 |
| serious Total, serious adverse events | 8 / 338 | 11 / 342 |
Outcome results
Primary
Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants
GMCs against each pertussis antigens (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], fimbriae types 2 and 3 \[FIM2+3\]) were assessed using an enzyme-linked immunosorbent assay (ELISA) method and were measured in ELISA unit/milliliter (EU/mL). Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
Time frame: 28 days after Tdap vaccination
Population: Per protocol analysis set of Tdap (PPT) included dengue immune participants who received at least one dose of Tdap and had no relevant protocol deviations. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants | Anti-PT | 65.2 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants | Anti-FHA | 273 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants | Anti-PRN | 50.6 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants | Anti-FIM2+3 | 705 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants | Anti-FIM2+3 | 643 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants | Anti-PT | 76.0 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants | Anti-PRN | 44.9 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants | Anti-FHA | 267 EU/mL |
Comparison: Anti-PT95% CI: [0.721, 0.997]
Comparison: Anti-FHA95% CI: [0.892, 1.18]
Comparison: Anti-PRN95% CI: [0.836, 1.46]
Comparison: Anti-FIM2+395% CI: [0.827, 1.33]
Primary
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants
The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.
Time frame: 28 days after first CYD dengue vaccination
Population: Analysis was performed on per-protocol analysis set for CYD dengue vaccine (PPC) population which included dengue immune participants who received 1st dose of CYD dengue vaccine and had no relevant protocol deviations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1 | 513 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2 | 677 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3 | 653 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4 | 378 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4 | 472 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1 | 461 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3 | 706 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2 | 568 titers |
Comparison: Serotype 195% CI: [0.862, 1.44]
Comparison: Serotype 295% CI: [0.97, 1.47]
Comparison: Serotype 395% CI: [0.739, 1.16]
Comparison: Serotype 495% CI: [0.644, 0.999]
Primary
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants
Seroprotection against diphtheria (Anti-D) and tetanus (Anti-T) antigens was performed by Micrometabolic Inhibition Test - Toxin Neutralization assay (MIT-TNA) and ELISA, respectively. Seroprotection was defined as anti-D and anti-T Ab concentration greater than 0.1 international units (IU)/mL. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
Time frame: 28 days after Tdap vaccination
Population: Analysis was performed on PPT population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-D | 90.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-T | 98.4 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-D | 89.8 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-T | 99.0 percentage of participants |
Comparison: Anti-D95% CI: [-4.53, 5.04]
Comparison: Anti-T95% CI: [-2.87, 1.37]
Secondary
Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants
GMCs against each pertussis antigens (PT, FHA, PRN, FIM2+3) were assessed using ELISA assay method and were measured in EU/mL. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
Time frame: Baseline (Pre-Tdap vaccination) and 28 days after the Tdap vaccination
Population: Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-PT: Pre-vaccination | 8.46 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-PT: 28 days post-vaccination | 65.0 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-FHA: Pre-vaccination | 19.9 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-FHA: 28 days post-vaccination | 272 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-PRN: Pre-vaccination | 3.79 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-PRN: 28 days post-vaccination | 50.6 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-FIM2+3: Pre-vaccination | 15.1 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-FIM2+3: 28 days post-vaccination | 700 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-FIM2+3: 28 days post-vaccination | 642 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-PT: Pre-vaccination | 9.56 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-PRN: Pre-vaccination | 3.65 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-PT: 28 days post-vaccination | 76.1 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-FIM2+3: Pre-vaccination | 14.9 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-FHA: Pre-vaccination | 19.4 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-PRN: 28 days post-vaccination | 45.0 EU/mL |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-FHA: 28 days post-vaccination | 266 EU/mL |
Secondary
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants
The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.
Time frame: Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination
Population: Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3: 28 days post-vaccination 1 | 655 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1: Pre-vaccination 1 | 265 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1: 28 days post-vaccination 1 | 513 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2: Pre-vaccination 1 | 404 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2: 28 days post-vaccination 1 | 679 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3: Pre-vaccination 1 | 327 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4: Pre-vaccination 1 | 136 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4: 28 days post-vaccination 1 | 379 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4: 28 days post-vaccination 1 | 478 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3: 28 days post-vaccination 1 | 709 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2: 28 days post-vaccination 1 | 577 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1: Pre-vaccination 1 | 250 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4: Pre-vaccination 1 | 172 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1: 28 days post-vaccination 1 | 468 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3: Pre-vaccination 1 | 327 titers |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2: Pre-vaccination 1 | 343 titers |
Secondary
Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Tdap or CYD Dengue Vaccine
Hospitalized suspected dengue case was defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned acute blood sample (within the first 5 days after fever onset) was collected for virological confirmation of hospitalized suspected dengue case. A suspected case was considered VCD if there was a detection of wild type dengue virus by dengue non-structural protein 1 antigen ELISA and/or dengue reverse transcriptase-polymerase chain reactions.
Time frame: From Day 0 up to 6 months after the last Tdap or CYD vaccination
Population: Analysis was performed on SafAS population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Tdap or CYD Dengue Vaccine | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Tdap or CYD Dengue Vaccine | 3 Participants |
Secondary
Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine
Non-serious AESIs were non-serious AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.
Time frame: Within 7 days post any and each vaccination
Population: Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD vaccination 2 (Visit 4) | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD/Tdap vaccination (Visit 2) | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine | Post any vaccination | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine | Post any vaccination | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD/Tdap vaccination (Visit 2) | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine | Post Tdap vaccination (Visit 1) | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD vaccination 2 (Visit 4) | 0 Participants |
Secondary
Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine
SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; required hospitalization or prolonged existing hospitalization; persistent or significant disability/incapacity; congenital anomaly or a medically important event. Serious AESIs were SAEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.
Time frame: From Day 0 up to 6 months after the last Tdap or CYD vaccination
Population: Analysis was performed on SafAS population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine | SAE | 8 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine | Serious AESI | 1 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine | SAE | 11 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine | Serious AESI | 3 Participants |
Secondary
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.
Time frame: Within 28 days after any and each vaccination
Population: Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD/Tdap vaccination (Visit 2) | 37 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine | Post any vaccination | 56 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD vaccination 2 (Visit 4) | 28 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD vaccination 2 (Visit 4) | 26 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD/Tdap vaccination (Visit 2) | 20 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine | Post any vaccination | 70 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine | Post Tdap vaccination (Visit 1) | 40 Participants |
Secondary
Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Any unsolicited AE occurred during first 30 minutes post-vaccination was recorded on the CRF as immediate AE. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccination and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.
Time frame: Within 30 minutes after any and each vaccination
Population: Analysis was performed on SafAS population, which included participants who received at least one dose of the study vaccines (CYD dengue or Tdap). Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD vaccination 2 (Visit 4) | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD/Tdap vaccination (Visit 2) | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine | Post any vaccination | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine | Post Tdap vaccination 1 (Visit 1) | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD vaccination 2 (Visit 4) | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine | Post any vaccination | 0 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine | Post CYD/Tdap vaccination (Visit 2) | 0 Participants |
Secondary
Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine
A solicited reaction (SR) was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema, and swelling. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.
Time frame: Within 7 days after any and each vaccination
Population: Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Pain: Post CYD/Tdap vaccination (Visit 2) | 218 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Swelling: Post CYD vaccination 2 (Visit 4) | 2 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Erythema: Post CYD/Tdap vaccination (Visit 2) | 13 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Pain: Post CYD vaccination 2 (Visit 4) | 61 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Erythema: Post CYD vaccination 2 (Visit 4) | 2 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Pain: Post any vaccination | 229 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Swelling: Post any vaccination | 25 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Erythema: Post any vaccination | 14 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Swelling: Post CYD/Tdap vaccination (Visit 2) | 25 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Erythema: Post CYD/Tdap vaccination (Visit 2) | 5 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Erythema: Post CYD vaccination 2 (Visit 4) | 2 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Swelling: Post any vaccination | 32 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Swelling: Post Tdap vaccination (Visit 1) | 30 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Swelling: Post CYD/Tdap vaccination (Visit 2) | 3 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Swelling: Post CYD vaccination 2 (Visit 4) | 2 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Pain: Post any vaccination | 237 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Pain: Post Tdap vaccination (Visit 1) | 212 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Pain: Post CYD/Tdap vaccination (Visit 2) | 53 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Pain: Post CYD vaccination 2 (Visit 4) | 55 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Erythema: Post any vaccination | 17 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Erythema: Post Tdap vaccination (Visit 1) | 14 Participants |
Secondary
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine
A SR reaction was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited injection site reactions included fever, headache, malaise, myalgia, and asthenia. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.
Time frame: Within 14 days after any and each vaccination
Population: Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Malaise: Post any vaccination | 91 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Fever: Post CYD vaccination 2 (Visit 4) | 10 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Fever: Post any vaccination | 21 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Malaise: Post CYD/Tdap vaccination (Visit 2) | 74 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Headache: Post any vaccination | 89 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Malaise: Post CYD vaccination 2 (Visit 4) | 32 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Myalgia: Post CYD vaccination 2 (Visit 4) | 26 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Myalgia: Post any vaccination | 74 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Myalgia: Post CYD/Tdap vaccination (Visit 2) | 67 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Headache: Post CYD/Tdap vaccination (Visit 2) | 70 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Fever: Post CYD/Tdap vaccination (Visit 2) | 11 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Asthenia: Post CYD/Tdap vaccination (Visit 2) | 59 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Headache: Post CYD vaccination 2 (Visit 4) | 36 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Asthenia: Post CYD vaccination 2 (Visit 4) | 19 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Asthenia: Post any vaccination | 67 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Myalgia: Post Tdap vaccination (Visit 1) | 78 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Asthenia: Post any vaccination | 94 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Asthenia: Post Tdap vaccination (Visit 1) | 69 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Asthenia: Post CYD/Tdap vaccination (Visit 2) | 24 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Myalgia: Post any vaccination | 100 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Asthenia: Post CYD vaccination 2 (Visit 4) | 22 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Myalgia: Post CYD/Tdap vaccination (Visit 2) | 30 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Myalgia: Post CYD vaccination 2 (Visit 4) | 22 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Fever: Post any vaccination | 30 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Fever: Post Tdap vaccination (Visit 1) | 15 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Fever: Post CYD/Tdap vaccination (Visit 2) | 6 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Fever: Post CYD vaccination 2 (Visit 4) | 9 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Headache: Post any vaccination | 115 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Headache: Post Tdap vaccination (Visit 1) | 83 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Headache: Post CYD/Tdap vaccination (Visit 2) | 33 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Headache: Post CYD vaccination 2 (Visit 4) | 35 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Malaise: Post any vaccination | 111 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Malaise: Post Tdap vaccination (Visit 1) | 81 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Malaise: Post CYD/Tdap vaccination (Visit 2) | 28 Participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine | Malaise: Post CYD vaccination 2 (Visit 4) | 33 Participants |
Secondary
Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants
The GMC against diphtheria and tetanus antigens was performed by MIT-TNA and ELISA, respectively. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
Time frame: Baseline (Pre-Tdap vaccination) and 28 days after the dose of Tdap vaccination
Population: Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-D: Pre-vaccination | 31.8 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-T: Pre-vaccination | 63.7 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-D: 28 days post-vaccination | 90.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-T: 28 days post-vaccination | 98.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-T: 28 days post-vaccination | 99.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-D: Pre-vaccination | 32.8 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-D: 28 days post-vaccination | 89.8 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants | Anti-T: Pre-vaccination | 69.6 percentage of participants |
Secondary
Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (1, 2, 3, and 4) were measured by PRNT50. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (\>=10 and \>=100 \[1/dilution\]) against at least 1, 2, 3, or 4 serotypes of CYD were reported. Here, 'dil'=dilution and vac=vaccination in the specified categories.
Time frame: Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination
Population: Analysis was performed on subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 1 Serotype: pre-vac 1: >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 1 Serotype: pre-vac1: >=100 (1/dil) | 97.8 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 1 Serotype: post-vac 1: >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 1 Serotype: post-vac 1: >=100 (1/dil) | 99.7 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 2 Serotype: pre-vac 1: >=10 (1/dil) | 96.5 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 2 Serotype: pre-vac 1: >=100 (1/dil) | 84.4 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 2 Serotype: post-vac 1: >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 2 Serotype: post-vac 1: >=100 (1/dil) | 95.8 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 3 Serotype: pre-vac 1: >=10 (1/dil) | 93.6 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 3 Serotype: pre-vac 1: >=100 (1/dil) | 76.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 3 Serotype: post-vac 1: >=10 (1/dil) | 99.7 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 3 Serotype: post-vac 1: >=100 (1/dil) | 90.4 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 4 Serotype: pre-vac 1: >=10 (1/dil) | 89.2 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 4 Serotype: pre-vac 1: >=100 (1/dil) | 52.9 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 4 Serotype: post-vac 1: >=10 (1/dil) | 97.4 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 4 Serotype: post-vac 1: >=100 (1/dil) | 73.8 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 4 Serotype: post-vac 1: >=100 (1/dil) | 75.6 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 1 Serotype: pre-vac 1: >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 3 Serotype: pre-vac 1: >=10 (1/dil) | 95.2 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 1 Serotype: pre-vac1: >=100 (1/dil) | 97.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 4 Serotype: pre-vac 1: >=10 (1/dil) | 91.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 1 Serotype: post-vac 1: >=10 (1/dil) | 100.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 3 Serotype: pre-vac 1: >=100 (1/dil) | 76.8 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 1 Serotype: post-vac 1: >=100 (1/dil) | 99.7 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 4 Serotype: post-vac 1: >=10 (1/dil) | 98.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 2 Serotype: pre-vac 1: >=10 (1/dil) | 98.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 3 Serotype: post-vac 1: >=10 (1/dil) | 99.4 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 2 Serotype: pre-vac 1: >=100 (1/dil) | 87.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 4 Serotype: pre-vac 1: >=100 (1/dil) | 54.3 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 2 Serotype: post-vac 1: >=10 (1/dil) | 99.7 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 3 Serotype: post-vac 1: >=100 (1/dil) | 92.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | At least 2 Serotype: post-vac 1: >=100 (1/dil) | 96.5 percentage of participants |
Secondary
Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants
The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
Time frame: Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination
Population: Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1: Pre-vaccination 1 | 92.7 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1: 28 days post-vaccination 1 | 97.8 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2: Pre-vaccination 1 | 98.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2: 28 days post-vaccination 1 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3: Pre-vaccination 1 | 95.5 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3: 28 days post-vaccination 1 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4: Pre-vaccination 1 | 93.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4: 28 days post-vaccination 1 | 99.4 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4: 28 days post-vaccination 1 | 100.0 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1: Pre-vaccination 1 | 93.3 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3: Pre-vaccination 1 | 97.1 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 1: 28 days post-vaccination 1 | 98.4 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 4: Pre-vaccination 1 | 97.5 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2: Pre-vaccination 1 | 96.5 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 3: 28 days post-vaccination 1 | 99.7 percentage of participants |
| CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) | Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants | Serotype 2: 28 days post-vaccination 1 | 99.0 percentage of participants |