Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00788151
First received: November 7, 2008
Last updated: August 29, 2011
Last verified: August 2011
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Purpose
This trial will evaluate the use of a tetravalent vaccine against dengue.
Primary Objectives:
- To describe the immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children previously vaccinated with yellow fever (YF) vaccine
- To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children.
| Condition | Intervention | Phase |
|---|---|---|
|
Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases |
Biological: Chimeric dengue serotype 1, 2, 3, and 4 Biological: Pneumococcal polysaccharide vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™ tetravalent dengue vaccine [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
- Safety: To provide information concerning the safety of ChimeriVax™ tetravalent dengue vaccine. [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
| Enrollment: | 300 |
| Study Start Date: | October 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Chimeric dengue serotype 1, 2, 3, and 4
0.5 mL, SC
Other Name: ChimeriVax™
|
| Sham Comparator: 2 |
Biological: Pneumococcal polysaccharide vaccine
0.5 mL, SC
Other Name: Pneumo23®
|
Detailed Description:
The control group will receive two doses of placebo and then one dose of Pneumo 23 vaccine for the third vaccination
Eligibility| Ages Eligible for Study: | 2 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- Aged 2 to 11 years on the day of inclusion.
- Subject in good health, based on medical history, physical examination and laboratory parameters.
- Provision of Assent Form signed by the subject (for subjects ≥8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]).
- Subject and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
- For a female subject of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.
- Documented receipt of yellow fever vaccine since at least one month before the first vaccination.
Exclusion Criteria :
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- For a female subject of child-bearing potential (girls post-menarche), known pregnancy.
- For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test 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 participation in another clinical trial during the trial.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Receipt of any blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
- 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.
- Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.
- Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.
- Known previous vaccination with pneumococcal polysaccharide vaccine.
Contacts and Locations
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: | NCT00788151 History of Changes |
| Other Study ID Numbers: | CYD24 |
| Study First Received: | November 7, 2008 |
| Last Updated: | August 29, 2011 |
| Health Authority: | Peru: General Directorate of Pharmaceuticals, Devices, and Drugs |
Keywords provided by Sanofi:
|
Dengue virus Dengue fever Dengue hemorrhagic fever Dengue diseases 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 May 21, 2013