Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

Phase 2

Completed

Conditions: Dengue Disease
Dengue Fever
Dengue Virus
Dengue Hemorrhagic Fever

Interventions: Biological: CYD dengue vaccine serotypes (1, 2, 3, 4).
Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide

Registration Number: NCT00875524

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Detailed Description: Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYD Dengue Vaccine Group	CYD dengue vaccine serotypes (1, 2, 3, 4).	Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
Control Vaccine Group	Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide	Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.

Primary Outcome Measures

Name	Time	Method
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.
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).
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 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 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.
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.