Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT02623725
• Date of registration: 03/12/2015
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule
• Scientific title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Given as a Booster Injection in Adolescents and Adults Who Previously Completed the 3-dose Schedule in a Study Conducted in Latin America
• Date of first enrolment: April 14, 2016
• Target sample size: 251
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02623725
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Brazil, Colombia, Honduras, Mexico, Puerto Rico

Contacts

• Name: Medical Director
• Affiliation: Sanofi Pasteur Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Had been identified as a potential participant by the Sponsor and is included in the
list provided to the Investigator (i.e., aged 9 to 16 years on the day of first
vaccination of CYD dengue vaccine in CYD13/CYD30 and has a post-dose 3 serum sample
available [at least 400 microliters of serum]).

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

- Assent form or informed consent form (ICF) had been signed and dated by the
participant (based on local regulations), and 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 and parent(s)/legally acceptable representative(s) attended all scheduled
visits and complied with all trial procedures.

Exclusion Criteria:

- Participant who received any other dengue vaccination that was not part of the CYD13
or CYD30 trials.

- 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 vaccination until at least 4 weeks after
vaccination).

- Participation at the time of study enrollment (or in the 4 weeks preceding the trial
vaccination) or planned participation during the present trial period in another
clinical trial investigating a vaccine, drug, medical device, or medical procedure.

- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned
receipt of any vaccine in the 4 weeks following the trial vaccination.

- Receipt of immune globulins, blood or blood-derived products in the past 3 months.

- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
within the preceding 6 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

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

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

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

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

- Current alcohol abuse or drug addiction.

- Moderate or severe acute illness/infection (according to investigator judgment) on the
day of vaccination or febrile illness (temperature >= 38.0°C). A prospective
participant should not be included in the study until the condition had resolved or
the febrile event had subsided.

- Identified as an Investigator or employee of the Investigator or study center 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.



Age minimum: 13 Years
Age maximum: 22 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dengue Hemorrhagic Fever

Dengue Fever

Intervention(s)

Biological: CYD Dengue Vaccine (5-dose formulation)

Biological: Placebo, NaCl 0.9%

Primary Outcome(s)

Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group [Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64]

Secondary Outcome(s)

GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64]

Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: 6 months,12 months, and 24 months post-booster injection in CYD64]

GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: 6 months,12 months, and 24 months post-booster injection in CYD64]

GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: Pre-booster injection (Day 0), 6 months, 12 months, and 24 months post-booster injection in CYD64]

Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: Pre-booster injection (Day 0) and 28 days post-booster injection]

Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: Within 14 days after booster injection]

GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group [Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64]

Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: Within 7 days after booster injection]

Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64]

GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64]

GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo [Time Frame: Pre-booster injection (Day 0) and 28 days post-booster injection]

GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: Pre-booster injection (Day 0) and 28 days post-booster injection]

Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: 28 days post-booster injection]

Secondary ID(s)

U1111-1161-2855

CYD64

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02623725