Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

NCT ID: NCT00875524

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

CYD Dengue Vaccine Group

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.

Group Type: EXPERIMENTAL

CYD dengue vaccine serotypes (1, 2, 3, 4).

Intervention Type: BIOLOGICAL

0.5 mL, Subcutaneous

Control Vaccine Group

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.

Group Type: SHAM_COMPARATOR

Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide

Intervention Type: BIOLOGICAL

Each at 0.5 mL, Subcutaneous, respectively

Interventions

CYD dengue vaccine serotypes (1, 2, 3, 4).

0.5 mL, Subcutaneous

Intervention Type: BIOLOGICAL

Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide

Each at 0.5 mL, Subcutaneous, respectively

Intervention Type: BIOLOGICAL

Other Intervention Names

ChimeriVax™; Meningococcal Polysaccharide Vaccine A+C; NaCl; Typhim Vi®

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).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc

Locations

Sanofi Pasteur Investigational Site

Long Xuyen, An Giang, Vietnam

Countries

Vietnam

Other Identifiers

2014-001709-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CYD22

Identifier Type: -

Identifier Source: org_study_id