Phase 2
Completed N=600
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
Dengue · Dengue Hemorrhagic Fever · Dengue Fever
Source: ClinicalTrials.gov NCT00993447 ↗
Enrolled (actual)
600
Serious AEs
4.2%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine — 64.9; 68.1; 73.1; 67.0 Percentage of participants
Summary
Primary objectives:
* To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine.
* To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
64.9; 68.1; 73.1; 67.0; 75.6; 67.8 | — |
| PRIMARY Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
81.3; 84.4; 90.8; 82.3; 90.5; 82.4 | — |
| PRIMARY Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
0.0; 0.0; 7.1; 2.7; 17.9; 5.6 | — |
| PRIMARY Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine |
75.1; 77.9; 98.2; 78.6; 99.2; 76.2 | — |
| PRIMARY Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine |
95.3; 96.9; 99.0; 93.7; 99.7; 91.9 | — |
| PRIMARY Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine |
0.0; 0.0; 95.0; 16.2; 97.4; 13.9 | — |
| PRIMARY Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
74.2; 81.9; 221; 77.1; 193; 96.6 | — |
| PRIMARY Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
2.36; 0.756; 2.74; 1.02; 1.19; 0.851 | — |
| PRIMARY Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
153; 162; 604; 148; 447; 192 | — |
| PRIMARY Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
3.49; 0.829; 3.25; 1.11; 1.25; 0.925 | — |
| PRIMARY Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
5.00; 5.00; 5.72; 5.15; 8.16; 6.18 | — |
| PRIMARY Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
0.572; 0.515; 1.43; 0.729; 0.990; 0.613 | — |
| PRIMARY Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine |
192; 132; 13; 7; 26; 18 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 9 to 16 years on the day of inclusion
- Subject in good health, based on medical history and physical examination
- Provision of assent form/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
- Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
- For a female subject 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 subject 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 subject'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
- Subject deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness (temperature ≥38.0°C) 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 (NCT00993447). 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.