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.
Participants will receive 3 doses of their randomized treatment (vaccine or placebo). Flavivirus status will be determined at baseline (before the first dose) and the vaccine immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will be collected in all subjects after each dose. Serious adverse events and adverse events of special interest will be collected throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
189
0.5 mL, Subcutaneous
0.5 ml, Subcutaneous
Unnamed facility
Bangalore, Karnataka, India
Unnamed facility
Ludhiana, Punjab, India
Unnamed facility
Kolkata, West Bengal, India
Unnamed facility
New Delhi, India
Unnamed facility
Pune, India
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
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
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
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
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
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
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.
Time frame: Day 0 up to Day 14 post each injection
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
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Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)