Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00730288
First received: August 6, 2008
Last updated: April 13, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine
Primary Objectives:
- To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.
- To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine
| Condition | Intervention | Phase |
|---|---|---|
|
Dengue Dengue Fever Dengue Hemorrhagic Fever Dengue Virus |
Biological: Chimeric dengue serotype (1, 2, 3, 4) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™ [ Time Frame: 28, 60 and 180 days post vaccination ] [ Designated as safety issue: No ]
- Safety: To provide information concerning the safety of ChimeriVax™ [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
| Enrollment: | 35 |
| Study Start Date: | August 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Received monovalent Vero dengue vaccine in Study DIV12
|
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
Other Name: ChimeriVax™ Dengue Tetravalent Vaccine
|
|
Experimental: 2
Received Yellow fever vaccine in Study DIV12
|
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
Other Name: ChimeriVax™ Dengue Tetravalent Vaccine
|
|
Experimental: 3
Flavivirus-naive subjects
|
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5mL, Subcutaneous, 1 dose
Other Name: ChimeriVax™ Dengue Tetravalent Vaccine
|
Detailed Description:
This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or YF vaccine.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- Aged 18 to 40 years on the day of inclusion.
- Informed consent form signed.
- For a woman, inability to bear a child or negative serum pregnancy test.
- Completed the one-year follow-up of Study DIV12.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least four weeks after vaccination.
Exclusion Criteria :
- History of thymic pathology (thymoma), thymectomy, or myasthenia gravis.
- Breast-feeding.
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Previous flavivirus vaccination, e.g. Japanese encephalitis or yellow fever.
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Planned participation in another clinical trial during the present trial period.
- History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Blood or blood-derived products received in the past three months.
- Vaccination planned in the four weeks following the trial vaccination.
- Flavivirus vaccination planned during the present trial period.
- Planned travel during the present trial period to areas with high dengue endemicity.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent.
- Participation in another clinical trial in the four weeks preceding the trial vaccination.
- Any vaccination in the four weeks preceding the trial vaccination.
- Human Immunodeficiency Virus (HIV), Hepatitis B (Ag HBs) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
- Laboratory abnormalities considered clinically significant upon the Investigator's judgement in blood sample taken at screening.
- Positive flavivirus serological test in blood sample taken at screening (for Controls only).
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00730288 History of Changes |
| Other Study ID Numbers: | CYD10 |
| Study First Received: | August 6, 2008 |
| Last Updated: | April 13, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council |
Keywords provided by Sanofi:
|
Dengue Dengue fever Dengue hemorrhagic fever Dengue virus |
Additional relevant MeSH terms:
|
Dengue Dengue Hemorrhagic Fever Fever Hemorrhagic Fevers, Viral Arbovirus Infections Virus Diseases |
Flavivirus Infections Flaviviridae Infections RNA Virus Infections Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013