Phase 2
N=180
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
Dengue Virus · Dengue Fever · Dengue Hemorrhagic Fever · Dengue Disease
Bottom Line
View on ClinicalTrials.gov: NCT00875524 ↗Enrolled (actual)
180
Serious AEs
3.3%
Results posted
Jul 2019
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine — 32.7; 19.6; 70.9; 18.8 Titers (1/dil)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CYD dengue vaccine serotypes (1, 2, 3, 4). (Biological); Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide (Biological)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine |
32.7; 19.6; 70.9; 18.8; 52.2; 19.8 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period |
103; 28.4; 72.9; 25.7; 56.0; 29.7 | — |
| PRIMARY Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine |
50.4; 43.3; 62.2; 41.7; 58.3; 39.7 | — |
| PRIMARY Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period |
78.8; 43.9; 74.1; 38.6; 59.8; 40.0 | — |
| PRIMARY Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine |
28.3; 80; 0.0; 0.0; 6.7; 21.7 | — |
| PRIMARY Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine |
27.5; 26.7; 0.8; 3.3; 35.3; 30.0 | — |
Summary
This trial evaluated the use of a tetravalent vaccine against dengue.
Primary objectives:
* To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children.
* To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts.
* To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.
Eligibility Criteria
Inclusion Criteria
- Aged 2 to 45 years on the day of inclusion.
- Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants <18 years).
- Participant (and parent/guardian for participants <18 years) 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 the first vaccination, until at least 4 weeks after the last vaccination.
- Participant in good health, based on medical history, physical examination and laboratory parameters.
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 serum pregnancy test at Screening.
- For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection.
- Breast-feeding female participant.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening.
- Planned participation in another clinical trial during the first year of the study.
- 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 corticosteroids therapy.
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to 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 past 3 months that might interfere with the assessment of immune response.
- Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening.
- 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 receipt of any vaccine in the 4 weeks following the first trial vaccination.
- Familial atopy medical history (parents, brothers, or sisters).
- Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior to inclusion.
- History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).
Data sourced from ClinicalTrials.gov (NCT00875524). 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.