Phase 2
Completed N=150
Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
Source: ClinicalTrials.gov NCT01187433 ↗Enrolled (actual)
150
Serious AEs
5.3%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo — 59.6; 63.3; 79.8; 69.4 Percentage of participants
Summary
The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America.
Primary Objectives:
* To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine.
* To evaluate the safety of each vaccination with CYD dengue vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
59.6; 63.3; 79.8; 69.4; 80.9; 72.3 | — |
| PRIMARY Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
73.8; 75.6; 88.8; 82.9; 91.0; 87.2 | — |
| PRIMARY Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
0.0; 0; 42.1; 0; 31.3; 0 | — |
| PRIMARY Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
68.7; 71.4; 97.0; 71.4; 94.7; 74.5 | — |
| PRIMARY Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
85.0; 85.4; 97.5; 85.4; 97.4; 89.7 | — |
| PRIMARY Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
0.0; 0; 94.7; 0; 81.3; 0 | — |
| PRIMARY Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
4.67; 0.834; 7.26; 2.11; 1.66; 1.25 | — |
| PRIMARY Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
41.4; 47.2; 256; 50.7; 230; 86 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
68.5; 73.1; 549; 79.8; 430; 154 | — |
| PRIMARY Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo |
1.03; 0.5; 5.73; 0.5; 3.25; 0.5 | — |
| PRIMARY Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo |
40; 40.8; 0; 4.1; 4.0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 9 to 16 years on the day of inclusion
- Participant in good health, based on medical history and physical examination
- Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative
- Participant and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
- For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination until at least 4 weeks after the last vaccination
Exclusion Criteria
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia
- For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Breast-feeding woman
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the components of any of the trial vaccines or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the preceding 3 months that might interfere with the assessment of immune response
- 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 administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness (temperature ≥ 38.0 ºC) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
- Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.
Data sourced from ClinicalTrials.gov (NCT01187433). 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.