Trial Outcomes & Findings for Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects (NCT NCT02992418)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

688 participants

Primary outcome timeframe

28 days after Tdap vaccination

Results posted on

2022-03-25

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) Participants received 1 booster dose of Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine 0.5 milliliter (mL) intramuscular (IM) injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL subcutaneous (SC) injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.	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.
Overall Study STARTED	346	342
Overall Study Safety Analysis Set (SafAS)	338	342
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	346	342

Reasons for withdrawal

Reasons for withdrawal
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) Participants received 1 booster dose of Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine 0.5 milliliter (mL) intramuscular (IM) injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL subcutaneous (SC) injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.	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.
Overall Study Withdrawal by Subject	11	12
Overall Study Non-compliance with the protocol	308	308
Overall Study Lost to Follow-up	27	22

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=346 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 Participants 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.	Total n=688 Participants Total of all reporting groups
Age, Continuous	26.2 years STANDARD_DEVIATION 16.3 • n=346 Participants	27.1 years STANDARD_DEVIATION 16.7 • n=342 Participants	26.6 years STANDARD_DEVIATION 16.5 • n=688 Participants
Sex: Female, Male Female	187 Participants n=346 Participants	193 Participants n=342 Participants	380 Participants n=688 Participants
Sex: Female, Male Male	159 Participants n=346 Participants	149 Participants n=342 Participants	308 Participants n=688 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Dengue Baseline Status Dengue immune	314 Participants n=346 Participants	315 Participants n=342 Participants	629 Participants n=688 Participants
Dengue Baseline Status Dengue non-immune	32 Participants n=346 Participants	27 Participants n=342 Participants	59 Participants n=688 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=312 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=314 Participants 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.
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 Interval 57.7 to 73.8	76.0 EU/mL Interval 67.9 to 85.1
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 Interval 248.0 to 299.0	267 EU/mL Interval 241.0 to 296.0
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 Interval 41.4 to 61.9	44.9 EU/mL Interval 36.7 to 55.0
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 Interval 586.0 to 847.0	643 EU/mL Interval 537.0 to 770.0

PRIMARY outcome

Timeframe: 28 days after Tdap vaccination

Population: Analysis was performed on PPT population. Here, 'Number analyzed' = participants with available data for each specified category.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=312 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=314 Participants 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.
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 Interval 86.2 to 93.1	89.8 percentage of participants Interval 85.9 to 92.9
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 Interval 96.3 to 99.5	99.0 percentage of participants Interval 97.2 to 99.8

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=312 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=308 Participants 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.
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 Interval 427.0 to 617.0	461 titers Interval 384.0 to 552.0
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 Interval 588.0 to 780.0	568 titers Interval 489.0 to 661.0
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 Interval 558.0 to 765.0	706 titers Interval 603.0 to 828.0
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 Interval 324.0 to 442.0	472 titers Interval 404.0 to 551.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=314 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=315 Participants 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.
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 Interval 218.0 to 322.0	250 titers Interval 208.0 to 300.0
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 Interval 427.0 to 616.0	468 titers Interval 392.0 to 560.0
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 Interval 350.0 to 467.0	343 titers Interval 294.0 to 401.0
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 Interval 589.0 to 781.0	577 titers Interval 497.0 to 671.0
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 Interval 274.0 to 391.0	327 titers Interval 280.0 to 383.0
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 Interval 559.0 to 767.0	709 titers Interval 605.0 to 830.0
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 Interval 115.0 to 160.0	172 titers Interval 150.0 to 197.0
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 Interval 325.0 to 443.0	478 titers Interval 410.0 to 557.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=314 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=315 Participants 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.
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 Interval 98.8 to 100.0	99.7 percentage of participants Interval 98.2 to 100.0
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 Interval 89.2 to 95.3	93.3 percentage of participants Interval 90.0 to 95.8
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 Interval 95.4 to 99.1	98.4 percentage of participants Interval 96.3 to 99.5
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 Interval 95.9 to 99.3	96.5 percentage of participants Interval 93.8 to 98.2
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 Interval 98.8 to 100.0	99.0 percentage of participants Interval 97.2 to 99.8
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 Interval 92.6 to 97.5	97.1 percentage of participants Interval 94.6 to 98.7
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 Interval 89.6 to 95.6	97.5 percentage of participants Interval 95.1 to 98.9
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 Interval 97.7 to 99.9	100.0 percentage of participants Interval 98.8 to 100.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=314 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=315 Participants 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.
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 Interval 98.8 to 100.0	100.0 percentage of participants Interval 98.8 to 100.0
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 Interval 95.5 to 99.1	97.1 percentage of participants Interval 94.6 to 98.7
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 Interval 98.8 to 100.0	100.0 percentage of participants Interval 98.8 to 100.0
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 Interval 98.2 to 100.0	99.7 percentage of participants Interval 98.2 to 100.0
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 Interval 93.8 to 98.2	98.1 percentage of participants Interval 95.9 to 99.3
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 Interval 79.9 to 88.2	87.0 percentage of participants Interval 82.8 to 90.5
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 Interval 98.8 to 100.0	99.7 percentage of participants Interval 98.2 to 100.0
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 Interval 93.0 to 97.8	96.5 percentage of participants Interval 93.8 to 98.2
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 Interval 90.3 to 96.1	95.2 percentage of participants Interval 92.3 to 97.3
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 Interval 71.0 to 80.7	76.8 percentage of participants Interval 71.8 to 81.4
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 Interval 98.2 to 100.0	99.4 percentage of participants Interval 97.7 to 99.9
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 Interval 86.6 to 93.4	92.1 percentage of participants Interval 88.5 to 94.8
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 Interval 85.2 to 92.4	91.1 percentage of participants Interval 87.4 to 94.0
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 Interval 47.2 to 58.5	54.3 percentage of participants Interval 48.6 to 59.9
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 Interval 95.0 to 98.9	98.1 percentage of participants Interval 95.9 to 99.3
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 Interval 68.6 to 78.6	75.6 percentage of participants Interval 70.4 to 80.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=314 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=315 Participants 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.
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 Interval 7.34 to 9.75	9.56 EU/mL Interval 8.33 to 11.0
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 Interval 57.5 to 73.5	76.1 EU/mL Interval 68.1 to 85.2
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 Interval 248.0 to 299.0	266 EU/mL Interval 240.0 to 295.0
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 Interval 3.39 to 4.24	3.65 EU/mL Interval 3.25 to 4.1
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 Interval 41.4 to 61.8	45.0 EU/mL Interval 36.8 to 55.1
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 Interval 12.4 to 18.5	14.9 EU/mL Interval 12.2 to 18.1
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 Interval 583.0 to 841.0	642 EU/mL Interval 537.0 to 769.0
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 Interval 17.6 to 22.6	19.4 EU/mL Interval 17.1 to 22.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=314 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=315 Participants 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.
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 Interval 26.7 to 37.3	32.8 percentage of participants Interval 27.6 to 38.3
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 Interval 58.1 to 69.0	69.6 percentage of participants Interval 64.2 to 74.7
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 Interval 86.2 to 93.2	89.8 percentage of participants Interval 86.0 to 92.9
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 Interval 95.8 to 99.3	99.0 percentage of participants Interval 97.2 to 99.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=338 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 Participants 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.
Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine Post any vaccination	0 Participants	0 Participants
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
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	0 Participants
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	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=338 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 Participants 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.
Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Pain: Post any vaccination	229 Participants	237 Participants
Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Pain: Post Tdap vaccination (Visit 1)	—	212 Participants
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	53 Participants
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	55 Participants
Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Erythema: Post any vaccination	14 Participants	17 Participants
Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Erythema: Post Tdap vaccination (Visit 1)	—	14 Participants
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	5 Participants
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	2 Participants
Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Swelling: Post any vaccination	25 Participants	32 Participants
Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Swelling: Post Tdap vaccination (Visit 1)	—	30 Participants
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	3 Participants
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	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=338 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 Participants 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.
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Fever: Post CYD/Tdap vaccination (Visit 2)	11 Participants	6 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Fever: Post CYD vaccination 2 (Visit 4)	10 Participants	9 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Headache: Post any vaccination	89 Participants	115 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Fever: Post any vaccination	21 Participants	30 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Fever: Post Tdap vaccination (Visit 1)	—	15 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Headache: Post Tdap vaccination (Visit 1)	—	83 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Headache: Post CYD/Tdap vaccination (Visit 2)	70 Participants	33 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Headache: Post CYD vaccination 2 (Visit 4)	36 Participants	35 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Malaise: Post any vaccination	91 Participants	111 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Malaise: Post Tdap vaccination (Visit 1)	—	81 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Malaise: Post CYD/Tdap vaccination (Visit 2)	74 Participants	28 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Malaise: Post CYD vaccination 2 (Visit 4)	32 Participants	33 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Myalgia: Post any vaccination	74 Participants	100 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Myalgia: Post Tdap vaccination (Visit 1)	—	78 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Myalgia: Post CYD/Tdap vaccination (Visit 2)	67 Participants	30 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Myalgia: Post CYD vaccination 2 (Visit 4)	26 Participants	22 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Asthenia: Post any vaccination	67 Participants	94 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Asthenia: Post Tdap vaccination (Visit 1)	—	69 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Asthenia: Post CYD/Tdap vaccination (Visit 2)	59 Participants	24 Participants
Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Asthenia: Post CYD vaccination 2 (Visit 4)	19 Participants	22 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=338 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 Participants 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.
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine Post any vaccination	56 Participants	70 Participants
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine Post Tdap vaccination (Visit 1)	—	40 Participants
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine Post CYD/Tdap vaccination (Visit 2)	37 Participants	20 Participants
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine Post CYD vaccination 2 (Visit 4)	28 Participants	26 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=338 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 Participants 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.
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	0 Participants
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	0 Participants
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
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	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 6 months after the last Tdap or CYD vaccination

Population: Analysis was performed on SafAS population.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=338 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 Participants 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.
Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine SAE	8 Participants	11 Participants
Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine Serious AESI	1 Participants	3 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 6 months after the last Tdap or CYD vaccination

Population: Analysis was performed on SafAS population.

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.

Outcome measures

Outcome measures
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=338 Participants 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 Participants 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.
Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Tdap or CYD Dengue Vaccine	0 Participants	3 Participants

Adverse Events

CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)

Serious events: 8 serious events

Other events: 248 other events

Deaths: 0 deaths

CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)

Serious events: 11 serious events

Other events: 263 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=338 participants at risk 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 participants at risk 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.
General disorders Asthenia	19.8% 67/338 • Number of events 78 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	27.5% 94/342 • Number of events 115 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
General disorders Injection Site Pain	67.8% 229/338 • Number of events 376 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	69.3% 237/342 • Number of events 320 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
General disorders Injection Site Swelling	7.4% 25/338 • Number of events 29 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	9.4% 32/342 • Number of events 35 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
General disorders Malaise	26.9% 91/338 • Number of events 106 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	32.5% 111/342 • Number of events 142 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
General disorders Pyrexia	6.5% 22/338 • Number of events 22 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	9.4% 32/342 • Number of events 33 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Infections and infestations Upper Respiratory Tract Infection	5.0% 17/338 • Number of events 17 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	5.0% 17/342 • Number of events 21 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Musculoskeletal and connective tissue disorders Myalgia	21.9% 74/338 • Number of events 93 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	29.2% 100/342 • Number of events 130 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Nervous system disorders Headache	26.3% 89/338 • Number of events 106 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	33.9% 116/342 • Number of events 152 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.

Additional Information

Trial Transparency Team

Sanofi Pasteur

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER

Measure	CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration) n=338 participants at risk 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.	CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration) n=342 participants at risk 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.
Infections and infestations Gastroenteritis	0.30% 1/338 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.29% 1/342 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Injury, poisoning and procedural complications Incisional Hernia	0.00% 0/338 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.29% 1/342 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Cardiac disorders Hypertensive Heart Disease	0.00% 0/338 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.29% 1/342 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Gastrointestinal disorders Dyspepsia	0.00% 0/338 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.29% 1/342 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Gastrointestinal disorders Gastritis	0.30% 1/338 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.00% 0/342 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Hepatobiliary disorders Jaundice Cholestatic	0.00% 0/338 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.29% 1/342 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Infections and infestations Appendicitis	0.30% 1/338 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.00% 0/342 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Infections and infestations Atypical Pneumonia	0.00% 0/338 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.29% 1/342 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Infections and infestations Dengue Fever	0.30% 1/338 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.88% 3/342 • Number of events 3 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/338 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.29% 1/342 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Nervous system disorders Cerebral Infarction	0.30% 1/338 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.00% 0/342 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Nervous system disorders Seizure	0.00% 0/338 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.29% 1/342 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Pregnancy, puerperium and perinatal conditions Abortion Complete	0.30% 1/338 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.00% 0/342 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Renal and urinary disorders Nephrolithiasis	0.30% 1/338 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.00% 0/342 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
Skin and subcutaneous tissue disorders Rash Generalised	0.30% 1/338 • Number of events 1 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.	0.00% 0/342 • AE data were collected from Day 0 up to Day 28 post any vaccination. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination. SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.