This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6. The secondary objectives were: * To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine. * To describe the neutralizing antibody responses to each of the 3 vaccine formulations. * To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.
All participants provided blood samples for immunogenicity assessments, while vaccine viremia was assessed in a subset of participants in each group. Safety was assessed in all participants as follows: solicited adverse event (AE) prelisted in the diary card were collected for 7 days after vaccination for solicited injection site reactions and 14 days for solicited systemic reactions , unsolicited AEs were collected for 28 days after vaccination, and serious adverse event (SAE) information collected throughout the study up to 6 months after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
260
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
Investigational Site 004
Hoover, Alabama, United States
Investigational Site 002
San Diego, California, United States
Investigational Site 005
Vallejo, California, United States
Investigational Site 001
New Orleans, Louisiana, United States
Investigational Site 003
Springfield, Missouri, United States
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Percentage of participants with antibody titers \>= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7)
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Percentage of participants with antibody titers \>= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT.
Time frame: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
Percentage of participants with antibody titers \>= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT. In this outcome measure, participants with antibody titers \>= 10 1/dil against any 1 of the 4 serotypes or any 2 of the 4 serotypes or any 3 of the 4 serotypes or with all 4 serotypes were reported.
Time frame: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Geometric mean titers against each dengue virus serotype (1, 2, 3 and 4) strain was measured by PRNT.
Time frame: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Solicited injection 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:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>=5 cm. Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>=5 cm.
Time frame: 7 days after any injection 1, 2 or 3
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: - Grade1: \>=37.5°C to \<=38.0°C (\>=99.5°F to \<=100.4°F), Grade 2: \>38.0°C to \<=39.0°C (\>100.4°F to \<= 102.2°F), Grade 3: \>39.0°C (\>102.2°F). 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.
Time frame: 14 days after any injection 1, 2 or 3
Number of Participants With Vaccine Viremia
Vaccine viremia (level of vaccine virus in blood samples taken from participants) was measured by an assay yellow fever reverse transcriptase polymerase chain reaction which allowed the detection of vaccine viremia of any serotype (1, 2, 3 and 4).
Time frame: 7 days post-injection 1 and 2, 14 days post-injection 1 and 2
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