CompletedPhase 3

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil®

Malaysia528 participantsStarted 2016-12-01

Plain-language summary

The aim of the study was to assess the safety and immunogenicity of the CYD dengue vaccine and Gardasil (Human Papillomavirus Quadrivalent \[Types 6, 11, 16, and 18\] Vaccine, Recombinant) when administered concomitantly or sequentially. Primary objectives: * To demonstrate that the humoral immune response (in terms of geometric mean titers \[GMTs\]) to Gardasil after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil. * To demonstrate that the humoral immune response to the CYD dengue vaccine after concomitant administration was non-inferior to sequential administration with Gardasil 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 Gardasil vaccine after concomitant administration was non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil. * To describe the humoral immune response to Gardasil at baseline and after each dose of Gardasil 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 Gardasil and the CYD dengue vaccine after each and any dose in each group.

Who can participate

Age range9 Years – 13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants aged 9 to 13 years (i.e., from the day of the 9th birthday to the day prior to the 14th birthday) on the day of inclusion. * Informed consent form (ICF) or Assent form (AF) had been signed and dated by the participant (based on local regulations), and/or ICF had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations). * Participant (or participant and parent\[s\] or another legally acceptable representative) was (were) able to attend all scheduled visits and complied with all trial procedures. * Participant in good health, based on medical history, and physical examination. Exclusion Criteria: * Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female had to be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination). * Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Planned receipt of any vaccine in the 4 weeks following any trial vaccination. * Previous vaccination against dengue disease with the trial vaccine. * Previous vaccin…

What they're measuring

Geometric Mean Titers (GMTs) Against Each Gardasil Vaccine Human Papillomavirus (HPV) Antigen (HPV-6, HPV-11, HPV-16, HPV-18) 28 Days After Last Gardasil Vaccination in the Previously Dengue Immune Participants

Timeframe: 28 days after the last Gardasil vaccination

Geometric Mean Titers Against Each Parental Dengue Virus Serotype 28 Days After Third CYD Dengue Vaccination in the Previously Dengue Immune Participants

Timeframe: 28 days after third CYD dengue vaccination

Trial details

NCT IDNCT02993757

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-27

Results submitted2020-05-21

View on ClinicalTrials.gov More Dengue Fever trials