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Immunogenicity and Safety of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.
The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects. Primary Objectives: * To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects. * To describe the safety of the CYD dengue vaccine after each dose in all subjects. Secondary Objective: * To detect symptomatic dengue cases occurring at any time in the trial.
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 189 |
| Start date | 2012-03 |
| Completion | 2014-02 |
Conditions
- Dengue
- Dengue Fever
- Dengue Hemorrhagic Fever
Interventions
- Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
- Placebo: NaCl 0.9% solution
Primary outcomes
- Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo — Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). - Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo — Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). - Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo — Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). - Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo — Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). - Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo — Day 0 up to Day 14 post each injection
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling \>100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.
Countries
India