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Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam
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.
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 180 |
| Start date | 2009-03 |
| Completion | 2014-12 |
Conditions
- Dengue Virus
- Dengue Fever
- Dengue Hemorrhagic Fever
- Dengue Disease
Interventions
- CYD dengue vaccine serotypes (1, 2, 3, 4).
- Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Primary outcomes
- 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 — Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT). - Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period — Year 1, Year 2, Year 3 and Year 4 after the Third Injection
GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT. - 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 — Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT. - 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 — Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT. - Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine — 7 days post-each injection
Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain:- Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema and Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>= 5 cm. - Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine — 14 days post-each injection
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: \>=37.5 degree Celsius (°C) to \<=38.0°C, Grade 2: \>38.0°C to \<=39.0°C, Grade 3: \>39.0°C. Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.
Countries
Vietnam