Phase 2
Completed N=1,198
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Dengue Fever · Dengue Hemorrhagic Fever · Dengue · Dengue Diseases
Source: ClinicalTrials.gov NCT00880893 ↗
Enrolled (actual)
1,198
Serious AEs
4.7%
Results posted
Jul 2019
Primary outcomePrimary: Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo — 53.9; 66.7; 1.0; 2.0 Percentage of participants
Summary
Primary Objectives:
* To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity.
* To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period.
* To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants.
Secondary Objectives:
* To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo |
53.9; 66.7; 1.0; 2.0; 7.2; 15.2 | — |
| PRIMARY Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo |
33.9; 30.0; 6.4; 7.5; 3.8; 6.3 | — |
| PRIMARY Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo |
14.6; 17.1; 22.9; 11.6; 30.1; 16.7 | — |
| PRIMARY Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo |
4.7; 8.5; 92.4; 10.8; 5.4; 2.1 | — |
| PRIMARY Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo |
19.6; 27.7; 100; 56.8; 6.1; 0.0 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo |
8.20; 8.23; 10.0; 7.09; 12.9; 7.85 | — |
| PRIMARY GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine |
5.33; 5.44; 60.7; 6.32; 5.85; 5.18 | — |
| SECONDARY Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo |
4.7; 8.0; 91.0; 8.9; 41.8; 6.8 | — |
| SECONDARY Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo |
5.7; 4.3; 67.4; 11.6; 25.8; 7.3 | — |
| SECONDARY Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo |
33.1; 38.8; 71.7; 39.5; 45.9; 31.8 | — |
| SECONDARY Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo |
19.6; 26.0; 100.0; 51.1; 92.3; 20.0 | — |
| SECONDARY Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo |
13.5; 15.2; 97.8; 25.6; 94.7; 7.3 | — |
| SECONDARY Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo |
46.5; 55.1; 100.0; 53.5; 96.7; 50.0 | — |
| SECONDARY GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine |
5.33; 5.42; 56.6; 6.06; 12.1; 5.52 | — |
| SECONDARY GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo |
6.47; 5.47; 28.5; 6.36; 9.69; 5.69 | — |
| SECONDARY GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo |
15.8; 19.2; 48.7; 16.2; 26.3; 15.2 | — |
| SECONDARY Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo |
96.3; 0.0; 74.1; 7.7; 55.6; 0.0 | — |
| SECONDARY Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo |
89.6; 12.5; 33.6; 6.5; 20.5; 0.0 | — |
| SECONDARY Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo |
94.4; 33.3; 58.8; 20.0; 46.7; 16.7 | — |
| SECONDARY Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo |
62.9; 8.1; 20.9; 5.6; 16.1; 5.9 | — |
| SECONDARY Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo |
89.3; 70.0; 77.8; 57.1; 86.3; 65.0 | — |
| SECONDARY Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo |
59.4; 14.3; 21.3; 9.5; 10.2; 5.3 | — |
Eligibility Criteria
Inclusion Criteria
- Aged from 2 to 45 years on the day of inclusion.
- Participant in good health, based on medical history and physical examination.
- Provision of informed consent form (and assent form for participants aged 6 to 12 years) signed by the participant and by the parent(s) or another legally acceptable representative for participants aged less than 21 years.
- Participants and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 4 weeks after the last vaccination.
Exclusion Criteria
- Febrile illness (temperature >= 37.5°C) or moderate or severe acute illness/infection on the day of the first vaccination, according to Investigator judgment.
- For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
- Breast-feeding woman.
- Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- Personal or family history of thymic pathology or myasthenia.
- Previous hepatitis A vaccination (for children only).
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroid therapy.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the 18 coming months.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
- Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Current or past alcohol abuse or drug addiction that may interfere with the participants ability to comply with trial procedures.
- Participant who plans to move to another country within the 18 coming months.
Data sourced from ClinicalTrials.gov (NCT00880893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.