Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00880893
First received: April 13, 2009
Last updated: February 5, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Primary Objectives:
- To evaluate safety after each CYD Dengue vaccination.
- To evaluate the immune response to each CYD Dengue serotype after each vaccination in a subset of subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Dengue Fever Dengue Hemorrhagic Fever Dengue Virus Dengue Diseases |
Biological: CYD Dengue vaccine Biological: NaCl + influenza virus or hepatitis A vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the safety of Sanofi Pasteur's CYD Dengue Vaccine. [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
- To provide information concerning the immunogenicity of Sanofi Pasteur's CYD Dengue Vaccine [ Time Frame: 28 following each vaccination ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CYD Dengue Vaccine Group
Participants will receive Sanofi Pasteur's CYD Dengue Vaccine at Day 0, Months 6 and 12, respectively.
|
Biological: CYD Dengue vaccine
0.5 mL, Subcutaneous on Day 0, Months 6 and 12
Other Name: Sanofi Pasteur's CYD Dengue Vaccine
|
|
Sham Comparator: Control Group
Participants will receive a NaCl (placebo) vaccine followed by either 2 Hepatitis A or 2 Influenza vaccines at Months 6 and 12, respectively.
|
Biological: NaCl + influenza virus or hepatitis A vaccine
0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)
Other Names:
|
Detailed Description:
This is a multicenter trial involving three vaccinations over a period of 1 year, and a 4-year follow-up following the last vaccination.
Eligibility| Ages Eligible for Study: | 2 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- Aged from 2 to 45 years on the day of inclusion.
- Subject in good health, based on medical history and physical examination.
- Provision of informed consent form (and assent form for subjects aged 6 to 12 years) signed by the subject and by the parent(s) or another legally acceptable representative for subjects aged less than 21 years.
- Subject and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 4 weeks after the last vaccination.
Exclusion Criteria :
- Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of the first vaccination, according to Investigator judgment.
- For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
- Breast-feeding woman.
- Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- Personal or family history of thymic pathology or myasthenia.
- Previous hepatitis A vaccination (for children only).
- 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 corticosteroid therapy.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
- 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 participation in another clinical trial during the 18 coming months.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Subject who plans to move to another country within the 18 coming months.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880893
Locations
| Singapore | |
| Singapore, Singapore, 308433 | |
| Singapore, Singapore, 119074 | |
| Singapore, Singapore, 229899 | |
| Singapore, Singapore, 169608 | |
| Singapore, Singapore, 529889 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
Additional Information:
Related Info 
Related Info 
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00880893 History of Changes |
| Other Study ID Numbers: | CYD28 |
| Study First Received: | April 13, 2009 |
| Last Updated: | February 5, 2013 |
| Health Authority: | Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) |
Keywords provided by Sanofi:
|
Dengue virus Dengue fever Dengue hemorrhagic fever Dengue diseases Sanofi Pasteur's CYD Dengue Vaccine |
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 June 17, 2013