NCT02992418 is a Phase 3 clinical trial of CYD Dengue Vaccine in Dengue Fever, sponsored by Sanofi Pasteur, a Sanofi Company.

Who is sponsoring NCT02992418?

NCT02992418 is sponsored by Sanofi Pasteur, a Sanofi Company.

What drugs are being tested in NCT02992418?

Interventions in NCT02992418: CYD Dengue Vaccine, Tdap: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine adsorbed, Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed.

What condition does NCT02992418 study?

NCT02992418 studies Dengue Fever, Dengue Hemorrhagic Fever.

Is NCT02992418 still recruiting?

NCT02992418 is currently terminated. Last updated 25 March 2022.

Are results published for NCT02992418?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-03-25 · How we verify

NCT02992418

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects

Terminated Phase 3 Results posted Last updated 25 March 2022

What this trial tests

Phase 3 trial testing CYD Dengue Vaccine in Dengue Fever in 688 participants. Terminated before completion.

Timeline

19 December 2016

Primary endpoint
10 December 2019

10 December 2019

Quick facts

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	688
Start date	19 December 2016
Primary completion	10 December 2019
Estimated completion	10 December 2019
Sites	4 locations across Philippines

Drugs / interventions tested

CYD Dengue Vaccine — full drug profile →
Tdap: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine adsorbed — full drug profile →
Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed — full drug profile →

Conditions studied

Dengue Fever — all drugs for Dengue Fever →
Dengue Hemorrhagic Fever — all drugs for Dengue Hemorrhagic Fever →

Sponsor

Sanofi Pasteur, a Sanofi Company — full company profile →

Who can join

Adults 9 to 60, any sex, with Dengue Fever or Dengue Hemorrhagic Fever. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 28 days after Tdap vaccination

GMCs against each pertussis antigens (pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], fimbriae types 2 and 3 \[FIM2+3\]) were assessed using an enzyme-linked immunosorbent assay (ELISA) method and were measured in ELISA unit/milliliter (EU/mL). Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain.

Anti-PT

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	65.2	57.7 – 73.8
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	76.0	67.9 – 85.1

Anti-FHA

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	273	248 – 299
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	267	241 – 296

Anti-PRN

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	50.6	41.4 – 61.9
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	44.9	36.7 – 55.0

Anti-FIM2+3

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	705	586 – 847
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	643	537 – 770

Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants Primary · 28 days after Tdap vaccination

Seroprotection against diphtheria (Anti-D) and tetanus (Anti-T) antigens was performed by Micrometabolic Inhibition Test - Toxin Neutralization assay (MIT-TNA) and ELISA, respectively. Seroprotection was defined as anti-D and anti-T Ab concentration greater than 0.1 international units (IU)/mL. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain.

Anti-D

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	90.1	86.2 – 93.1
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	89.8	85.9 – 92.9

Anti-T

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	98.4	96.3 – 99.5
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	99.0	97.2 – 99.8

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 Primary · 28 days after first CYD dengue vaccination

The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.

Serotype 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	513	427 – 617
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	461	384 – 552

Serotype 2

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	677	588 – 780
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	568	489 – 661

Serotype 3

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	653	558 – 765
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	706	603 – 828

Serotype 4

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	378	324 – 442
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	472	404 – 551

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 Secondary · Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination

The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.

Serotype 1: Pre-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	265	218 – 322
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	250	208 – 300

Serotype 1: 28 days post-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	513	427 – 616
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	468	392 – 560

Serotype 2: Pre-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	404	350 – 467
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	343	294 – 401

Serotype 2: 28 days post-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	679	589 – 781
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	577	497 – 671

Serotype 3: Pre-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	327	274 – 391
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	327	280 – 383

Serotype 3: 28 days post-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	655	559 – 767
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	709	605 – 830

Serotype 4: Pre-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	136	115 – 160
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	172	150 – 197

Serotype 4: 28 days post-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	379	325 – 443
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	478	410 – 557

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 Secondary · Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination

Serotype 1: Pre-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	92.7	89.2 – 95.3
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	93.3	90.0 – 95.8

Serotype 1: 28 days post-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	97.8	95.4 – 99.1
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	98.4	96.3 – 99.5

Serotype 2: Pre-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	98.1	95.9 – 99.3
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	96.5	93.8 – 98.2

Serotype 2: 28 days post-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	100.0	98.8 – 100.0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	99.0	97.2 – 99.8

Serotype 3: Pre-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	95.5	92.6 – 97.5
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	97.1	94.6 – 98.7

Serotype 3: 28 days post-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	100.0	98.8 – 100.0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	99.7	98.2 – 100.0

Serotype 4: Pre-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	93.0	89.6 – 95.6
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	97.5	95.1 – 98.9

Serotype 4: 28 days post-vaccination 1

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	99.4	97.7 – 99.9
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	100.0	98.8 – 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 Secondary · Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination

Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (1, 2, 3, and 4) were measured by PRNT50. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (\>=10 and \>=100 \[1/dilution\]) against at least 1, 2, 3, or 4 serotypes of CYD were reported. Here, 'dil'=dilution and "vac"=vaccination in the specified categories.

At least 1 Serotype: pre-vac 1: >=10 (1/dil)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	100.0	98.8 – 100.0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	100.0	98.8 – 100.0

At least 1 Serotype: pre-vac1: >=100 (1/dil)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	97.8	95.5 – 99.1
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	97.1	94.6 – 98.7

At least 1 Serotype: post-vac 1: >=10 (1/dil)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	100.0	98.8 – 100.0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	100.0	98.8 – 100.0

At least 1 Serotype: post-vac 1: >=100 (1/dil)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	99.7	98.2 – 100.0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	99.7	98.2 – 100.0

At least 2 Serotype: pre-vac 1: >=10 (1/dil)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	96.5	93.8 – 98.2
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	98.1	95.9 – 99.3

At least 2 Serotype: pre-vac 1: >=100 (1/dil)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	84.4	79.9 – 88.2
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	87.0	82.8 – 90.5

At least 2 Serotype: post-vac 1: >=10 (1/dil)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	100.0	98.8 – 100.0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	99.7	98.2 – 100.0

At least 2 Serotype: post-vac 1: >=100 (1/dil)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	95.8	93.0 – 97.8
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	96.5	93.8 – 98.2

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 Secondary · Baseline (Pre-Tdap vaccination) and 28 days after the Tdap vaccination

GMCs against each pertussis antigens (PT, FHA, PRN, FIM2+3) were assessed using ELISA assay method and were measured in EU/mL. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain.

Anti-PT: Pre-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	8.46	7.34 – 9.75
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	9.56	8.33 – 11.0

Anti-PT: 28 days post-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	65.0	57.5 – 73.5
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	76.1	68.1 – 85.2

Anti-FHA: Pre-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	19.9	17.6 – 22.6
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	19.4	17.1 – 22.1

Anti-FHA: 28 days post-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	272	248 – 299
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	266	240 – 295

Anti-PRN: Pre-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	3.79	3.39 – 4.24
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	3.65	3.25 – 4.10

Anti-PRN: 28 days post-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	50.6	41.4 – 61.8
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	45.0	36.8 – 55.1

Anti-FIM2+3: Pre-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	15.1	12.4 – 18.5
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	14.9	12.2 – 18.1

Anti-FIM2+3: 28 days post-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	700	583 – 841
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	642	537 – 769

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 Secondary · Baseline (Pre-Tdap vaccination) and 28 days after the dose of Tdap vaccination

The GMC against diphtheria and tetanus antigens was performed by MIT-TNA and ELISA, respectively. Dengue immune participants at Baseline were defined as participants with titers \>=10 (1/dilution) for at least one serotype with the parental dengue virus strain.

Anti-D: Pre-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	31.8	26.7 – 37.3
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	32.8	27.6 – 38.3

Anti-T: Pre-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	63.7	58.1 – 69.0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	69.6	64.2 – 74.7

Anti-D: 28 days post-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	90.1	86.2 – 93.2
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	89.8	86.0 – 92.9

Anti-T: 28 days post-vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	98.1	95.8 – 99.3
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	99.0	97.2 – 99.8

Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine Secondary · Within 30 minutes after any and each vaccination

An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Any unsolicited AE occurred during first 30 minutes post-vaccination was recorded on the CRF as immediate AE. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccination and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD va

Post any vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	0

Post Tdap vaccination 1 (Visit 1)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	0

Post CYD/Tdap vaccination (Visit 2)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	0

Post CYD vaccination 2 (Visit 4)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	0
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	0

Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Secondary · Within 7 days after any and each vaccination

A solicited reaction (SR) was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema, and swelling. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.

Pain: Post any vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	229
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	237

Pain: Post Tdap vaccination (Visit 1)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	212

Pain: Post CYD/Tdap vaccination (Visit 2)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	218
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	53

Pain: Post CYD vaccination 2 (Visit 4)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	61
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	55

Erythema: Post any vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	14
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	17

Erythema: Post Tdap vaccination (Visit 1)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	14

Erythema: Post CYD/Tdap vaccination (Visit 2)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	13
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	5

Erythema: Post CYD vaccination 2 (Visit 4)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	2
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	2

Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine Secondary · Within 14 days after any and each vaccination

A SR reaction was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited injection site reactions included fever, headache, malaise, myalgia, and asthenia. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.

Fever: Post any vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	21
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	30

Fever: Post Tdap vaccination (Visit 1)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	15

Fever: Post CYD/Tdap vaccination (Visit 2)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	11
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	6

Fever: Post CYD vaccination 2 (Visit 4)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	10
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	9

Headache: Post any vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	89
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	115

Headache: Post Tdap vaccination (Visit 1)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	83

Headache: Post CYD/Tdap vaccination (Visit 2)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	70
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	33

Headache: Post CYD vaccination 2 (Visit 4)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	36
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	35

Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine Secondary · Within 28 days after any and each vaccination

An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.

Post any vaccination

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	56
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	70

Post Tdap vaccination (Visit 1)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	40

Post CYD/Tdap vaccination (Visit 2)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	37
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	20

Post CYD vaccination 2 (Visit 4)

Group	Value	95% CI
CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)	28
CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)	26

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)

Serious: 8/338 (2%)

Deaths: 0/338

CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)

Serious: 11/342 (3%)

Deaths: 0/342

Serious adverse events (15 terms)

Reaction	System	CYD Dengue Vaccine + Tdap …	CYD Dengue Vaccine + Tdap …
Dengue Fever	Infections and infestations	—	—
Hypertensive Heart Disease	Cardiac disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Gastritis	Gastrointestinal disorders	—	—
Jaundice Cholestatic	Hepatobiliary disorders	—	—
Appendicitis	Infections and infestations	—	—
Atypical Pneumonia	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Incisional Hernia	Injury, poisoning and procedural complications	—	—
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cerebral Infarction	Nervous system disorders	—	—
Seizure	Nervous system disorders	—	—
Abortion Complete	Pregnancy, puerperium and perinatal conditions	—	—
Nephrolithiasis	Renal and urinary disorders	—	—
Rash Generalised	Skin and subcutaneous tissue disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	CYD Dengue Vaccine + Tdap …	CYD Dengue Vaccine + Tdap …
Injection Site Pain	General disorders	—	—
Headache	Nervous system disorders	—	—
Malaise	General disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Asthenia	General disorders	—	—
Injection Site Swelling	General disorders	—	—
Pyrexia	General disorders	—	—
Upper Respiratory Tract Infection	Infections and infestations	—	—

Most-reported serious reactions: Dengue Fever, Hypertensive Heart Disease, Dyspepsia, Gastritis, Jaundice Cholestatic, Appendicitis, Atypical Pneumonia, Gastroenteritis.

Data from ClinicalTrials.gov NCT02992418 adverse events section.

Sponsor's own description

The aim of the study was to investigate the immunogenicity and safety of CYD dengue vaccine and Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine when both vaccines were administered concomitantly or sequentially. Primary Objectives: * To demonstrate the non-inferiority of the humoral immune response to the Tdap booster dose concomitantly administered with the first dose of CYD dengue vaccine as compared to sequential administration, measured 28 days after Tdap booster dose. * To demonstrate the non-inferiority of the humoral immune response to the first dose of CYD dengue vaccine concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the first dose of CYD dengue vaccine. Secondary Objectives: * To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD dengue vaccine with the first dose concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the third dose of CYD dengue vaccine. * To describe the humoral immune response at baseline and 28 days after the first and third doses of CYD dengue vaccine, in each and any group. * To describe the humoral immune response of Tdap vaccine at baseline and 28 days after concomitant administration with the first dose of CYD dengue vaccine as compared to the sequential administration, in each and any group. * To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each and any injection in each group.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

A review of Dengvaxia®: development to deployment.
Thomas SJ, Yoon IK. · · 2019 · cited 223× · PMID 31589551 · DOI 10.1080/21645515.2019.1658503
Anti-dengue Vaccines: From Development to Clinical Trials.
Pinheiro-Michelsen JR, Souza RDSO, Santana IVR, da Silva PS, et al · · 2020 · cited 37× · PMID 32655561 · DOI 10.3389/fimmu.2020.01252
Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Tdap Vaccine: Randomized Phase IIIb Trial in Healthy Participants 9-60 Years of Age in the Philippines.
Santos J, Montellano ME, Solante R, Perreras N, et al · · 2021 · cited 3× · PMID 34117198 · DOI 10.1097/inf.0000000000003220

Verify or expand the search:

Other trials of CYD Dengue Vaccine

Trials testing the same drug.

NCT02741128 — Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults · Phase 2 · completed
NCT02993757 — Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil® · Phase 3 · completed
NCT02979535 — Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix® · Phase 3 · completed
NCT02628444 — Immunogenicity and Safety of Different Vaccination Schedules of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Y · Phase 2 · completed
NCT01943825 — Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine · Phase 2 · completed

Other recruiting trials for Dengue Fever

Currently open trials in the same condition.

NCT06579755 — A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years) · Phase 3 · recruiting
NCT07409857 — International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR) · recruiting
NCT07047521 — A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults · Phase 3 · active not recruiting
NCT07007585 — Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection · recruiting
NCT06665035 — A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers · Phase 3 · recruiting

Other Sanofi Pasteur, a Sanofi Company trials

Trials by the same sponsor.

NCT07536048 — A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 Years · not yet recruiting
NCT07222059 — Phase 3 Single Arm, Open Study on vYF in Adults · Phase 3 · completed
NCT07013747 — Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne · Phase 1, PHASE2 · recruiting
NCT06838000 — Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) i · Phase 3 · active not recruiting
NCT06793826 — Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02992418 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi Pasteur, a Sanofi Company
Last refreshed: 25 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02992418.

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