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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT02992418
• Date of registration: 12/12/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects
• Scientific title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects Aged 9 to 60 Years in the Philippines
• Date of first enrolment: December 19, 2016
• Target sample size: 688
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02992418
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Philippines

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur SA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant aged 9 to 60 years (i.e., from the day of the 9th birthday to the day
prior to the 61th birthday) on the day of inclusion.

- Participant in good health, based on medical history and physical examination.

- Informed consent form (ICF) or assent form was signed and dated by the participant
(based on local regulations), and/or ICF was signed and dated by the parent(s) or
another legally acceptable representative (and by an independent witness if required
by local regulations).

- For participant aged 9 to 11 years: known (documented) receipt of at least 4 previous
doses of diphtheria toxoid, tetanus toxoid and acellular pertussis-containing (DTaP)
vaccines, with the last dose not within the last 5 years prior to enrolment.

OR For participant aged at least 12 years: known (documented or self-reported) receipt of
at least 3 previous doses of diphtheria toxoid, tetanus toxoid, and whole cell
pertussis-containing (DTwP) vaccines, with the last dose not within the last 5 years prior
to enrolment.

- Participant (or participant and parent[s]/legally acceptable representatives) was able
to attend all scheduled visits and complied with all trial procedures.

Exclusion Criteria:

- Participant was pregnant, or lactating, or of childbearing potential (to be considered
of non-childbearing potential, a female must be pre-menarche or post-menopausal for at
least 1 year, surgically sterile, or using an effective method of contraception or
abstinence from at least 4 weeks prior to the first vaccination 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 CYD dengue vaccine.

- Receipt of immune globulins, blood or blood-derived products in the past 3 months,
which might interfere with assessment of the immune response.

- Known or suspected congenital or acquired immunodeficiency (including human
immunodeficiency virus (HIV) infection with impaired immune function); or receipt of
immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or
equivalent for more than 2 consecutive weeks within the past 3 months).

- A previous severe reaction to pertussis, diphtheria or tetanus vaccine including
immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of
receiving the vaccine.

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccine used in the trial or to a vaccine containing
any of the same substances.

- Thrombocytopenia, contraindicating IM vaccination.

- Bleeding disorder or receipt of anticoagulants within 3 weeks preceding inclusion,
which might be a contraindication for IM vaccination, at the discretion of the
Investigator.

- Deprived of freedom by administrative or court order, or in an emergency setting, or
hospitalized involuntarily.

- Current alcohol abuse or drug addiction that, based on Investigator's judgment, may
interfere with the participant's ability to comply with trial procedures.

- Chronic illness that, in the opinion of the Investigator, was at a stage where it
might interfere with trial conduct or completion.

- Identified as an Investigator or employee of the Investigator with direct involvement
in the proposed study, or identified as an immediate family member (i.e., parent,
spouse, natural or adopted child) of the Investigator or employee with direct
involvement in the proposed study.

- Self-reported HIV, Hepatitis B, or Hepatitis C infection.

- Personal history of Guillain-Barré syndrome.



Age minimum: 9 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dengue Hemorrhagic Fever

Dengue Fever

Intervention(s)

Biological: Tdap: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine adsorbed

Biological: CYD Dengue Vaccine

Primary Outcome(s)

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 [Time Frame: 28 days after Tdap vaccination]

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 [Time Frame: 28 days after first CYD dengue vaccination]

Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants [Time Frame: 28 days after Tdap vaccination]

Secondary Outcome(s)

Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine [Time Frame: From Day 0 up to 6 months after the last Tdap or CYD vaccination]

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 [Time Frame: Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination]

Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine [Time Frame: Within 7 days after any and each vaccination]

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 [Time Frame: Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination]

Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Tdap or CYD Dengue Vaccine [Time Frame: From Day 0 up to 6 months after the last Tdap or CYD vaccination]

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 [Time Frame: Baseline (Pre-Tdap vaccination) and 28 days after the dose of Tdap vaccination]

Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine [Time Frame: Within 30 minutes after any and each vaccination]

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 [Time Frame: Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination]

Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine [Time Frame: Within 28 days after any and each vaccination]

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 [Time Frame: Baseline (Pre-Tdap vaccination) and 28 days after the Tdap vaccination]

Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine [Time Frame: Within 7 days post any and each vaccination]

Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine [Time Frame: Within 14 days after any and each vaccination]

Secondary ID(s)

U1111-1161-3294

2019-003136-23

CYD66

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02992418