Adults 9 to 14, female only, 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 Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive ParticipantsPrimary· 28 days after the last Cervarix vaccination
GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (\>=) 10 (1/dilutions \[dil\]) for at least one serotype with the parental dengue virus strain.
GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive ParticipantsPrimary· 28 days after third CYD dengue vaccination
The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive ParticipantsSecondary· Day 0 and 28 days after each Cervarix vaccination
The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive ParticipantsSecondary· 28 days after each Cervarix vaccination
Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than \[\>\] lower limit of quantitation \[LLOQ\] of the assay) or \>=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens \> LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (\<) 2.0 International Units per milliliter (IU/mL).
GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive ParticipantsSecondary· Day 0 and 28 days after each CYD dengue vaccine vaccination
The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive ParticipantsSecondary· Day 0 and 28 days after each CYD dengue vaccine vaccination
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive ParticipantsSecondary· Day 0 and 28 days after each CYD dengue vaccination
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain.
Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive ParticipantsSecondary· Day 0 and 28 days after each CYD dengue vaccination
Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers \>=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (\<10, \>=10 and \>=100 \[1/dil\]) against each dengue virus serotypes of CYD were reported.
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue VaccineSecondary· Within 30 minutes after each and any vaccination
Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE.
Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue VaccineSecondary· Up to 7 days after each and any vaccination
Solicited injection site reactions included pain, erythema, and swelling.
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue VaccineSecondary· Up to 14 days after any and each vaccination
Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue VaccineSecondary· Up to 28 days after any and each vaccination
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
Time frame: AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The aim of this study was to investigate the immunogenicity and safety of CYD dengue vaccine and Cervarix when administered concomitantly or sequentially in healthy female participants aged 9-14 years of age.
Primary objectives:
* To demonstrate that the humoral immune response (in terms of geometric mean titers \[GMTs\]) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of GMTs) after sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.
* To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after concomitant administration with Cervarix is non-inferior to the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after sequential administration with Cervarix measured 28 days after the last dose of the CYD dengue vaccine.
Secondary Objectives:
* To demonstrate that the humoral immune response (in terms of seroconversion) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of seroconversion) to Cervarix sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix.
* To describe the humoral immune response to Cervarix at baseline and after each dose of Cervarix in each and any group.
* To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine, in each and any group.
* To describe the safety of Cervarix and CYD dengue vaccine after each and any dose in each group.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02741128 — Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
· Phase 2
· completed
NCT02992418 — Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects
· Phase 3
· terminated
NCT02993757 — Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil®
· 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
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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/NCT02979535.