Clinical trial NCT00875524: Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
Official title: Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Disease
Keywords: Dengue virus
Dengue fever
Dengue hemorrhagic fever
Dengue diseases
Dengue vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria :

* Aged 2 to 45 years on the day of inclusion.
* Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants \<18 years).
* Participant (and parent/guardian for participants \<18 years) able to attend all scheduled visits and to comply with all trial procedures.
* For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
* Participant in good health, based on medical history, physical examination and laboratory parameters.

Exclusion Criteria :

* Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
* For a female participant of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening.
* For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection.
* Breast-feeding female participant.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
* Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening.
* Planned participation in another clinical trial during the first year of the study.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroids therapy.
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
* Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
* Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
* Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
* Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening.
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
* Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
* Familial atopy medical history (parents, brothers, or sisters).
* Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior to inclusion.
* History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).

Primary outcomes:
measure: 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
timeFrame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
measure: Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
timeFrame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
measure: 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
timeFrame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
measure: 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
timeFrame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
measure: Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
timeFrame: 7 days post-each injection
measure: Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
timeFrame: 14 days post-each injection
Secondary outcomes:
Other outcomes:
Locations:
city: Long Xuyên
country: Vietnam
facility: Sanofi Pasteur Investigational Site
state: An Giang Province
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Monitor
role: STUDY_DIRECTOR
References: