Immunogenicity and Safety of a Tetravalent Dengue Vaccine Booster Injection in Subjects Who Previously Completed a 3-dose Schedule

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT02824198
• Date of registration: 01/07/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Booster Injection in Subjects Who Previously Completed a 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 Singapore
• Date of first enrolment: July 1, 2016
• Target sample size: 118
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02824198
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Singapore

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 was included in the
list provided to the investigator (i.e., aged 9 to 45 years on the day of first
injection of CYD dengue vaccine in CYD28, had received 3 doses of CYD dengue vaccine
in the CYD28 trial, and had a post-dose 3 serum sample available).

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

- Informed consent form (ICF) had been signed and dated by 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) was able to attend all
scheduled visits to comply with all trial procedures.

Exclusion Criteria:

- Participant who received any other dengue vaccination that was not part of CYD28.

- Participant was pregnant, or lactating, or of childbearing potential (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, is 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: 14 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dengue Hemorrhagic Fever

Dengue Fever

Intervention(s)

Biological: Placebo, NaCl 0.9%

Biological: CYD Dengue Vaccine (5 dose formulation)

Primary Outcome(s)

Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group [Time Frame: 28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63]

Secondary Outcome(s)

GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63 [Time Frame: 28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD 63]

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]

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]

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]

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) and 6 months, 12 months, 24 months post-booster injection]

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]

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]

GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: 28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD63]

Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo [Time Frame: 28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63]

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]

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 Either CYD Dengue Vaccine or Placebo [Time Frame: 6 months, 12 months, and 24 months post-booster injection]

Secondary ID(s)

CYD63

U1111-1161-2813

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/NCT02824198