| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | 28 days after Tdap vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| Anti-PT | - ParticipantsOG000300
- ParticipantsOG001310
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | GMC ratio | 0.848 | | | 2-Sided | 95 | 0.721 | 0.997 | | | | | Non-Inferiority | Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMCs between groups (Group 1/ Group 2) was greater than (>) 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority. | | |
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| 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. | Analysis was performed on PPT population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 28 days after Tdap vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | 28 days after first CYD dengue vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | Baseline (Pre-Tdap vaccination) and 28 days after the Tdap vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline (Pre-Tdap vaccination) and 28 days after the dose of Tdap vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Count of Participants | | Participants | | Within 30 minutes after any and each vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | | Count of Participants | | Participants | | Within 7 days after any and each vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | | Count of Participants | | Participants | | Within 14 days after any and each vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | | Count of Participants | | Participants | | Within 28 days after any and each vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | | Count of Participants | | Participants | | Within 7 days post any and each vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was performed on SafAS population. | Posted | | Count of Participants | | Participants | | From Day 0 up to 6 months after the last Tdap or CYD vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was performed on SafAS population. | Posted | | Count of Participants | | Participants | | From Day 0 up to 6 months after the last Tdap or CYD vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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