Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00314132
First received: April 11, 2006
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
| Condition | Intervention | Phase |
|---|---|---|
|
Encephalitis Japanese Encephalitis |
Biological: ChimeriVax-JE, Japanese Encephalitis vaccine Biological: 0.9% Saline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE) |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo [ Time Frame: Day 0 up to 30 days post-vaccination ] [ Designated as safety issue: No ]Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
- Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo [ Time Frame: Day 0 up to 30 days post-vaccination ] [ Designated as safety issue: No ]
Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.
Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.
| Enrollment: | 2004 |
| Study Start Date: | October 2005 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
All subjects received a single injection of placebo on Day 0.
|
Biological: 0.9% Saline
0.5 mL, Subcutaneous
|
|
Experimental: ChimeriVax™ JE 4 log10 PFU Vaccine
All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
|
Biological: ChimeriVax-JE, Japanese Encephalitis vaccine
0.5 mL, Subcutaneous
Other Name: ChimeriVax™
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Informed consent obtained from the subject.
- Aged 18 years or above at screening.
- In good general health
- Subject available for the study duration
- For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.
Exclusion Criteria:
- A history of vaccination against or infection with JE.
- Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.
- History of thymoma, thymic surgery (removal) or myasthenia gravis.
- Clinically significant abnormalities on laboratory assessment
- Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).
- Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30.
- Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.
- Physical examination indicating any clinically significant medical condition.
- Oral temperature >38°C (100.4°F) or acute illness within 3 days prior to inoculation.
- Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.
- Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.
- Lactation or intended pregnancy in female subjects.
- Excessive alcohol consumption, drug abuse, significant psychiatric illness.
- A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).
- Participation in another clinical study within 30 days of the screening visit for this study.
- Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.
- Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314132
Locations
| United States, California | |
| Burbank, California, United States, 92505 | |
| Costa Mesa, California, United States, 92708 | |
| Davis, California, United States, 95616 | |
| San Francisco, California, United States, 94102 | |
| Vallejo, California, United States, 94589 | |
| United States, Florida | |
| Miami, Florida, United States, 33173 | |
| Orlando, Florida, United States, 32809 | |
| Pembroke Pines, Florida, United States, 33024 | |
| United States, Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Overland Park, Kansas, United States, 66212 | |
| United States, Kentucky | |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Michigan | |
| Livonia, Michigan, United States, 48152 | |
| United States, Missouri | |
| Sprnigfield, Missouri, United States, 65802 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68134 | |
| United States, North Carolina | |
| Winston Salem, North Carolina, United States, 27109 | |
| United States, Texas | |
| Fort Worth, Texas, United States, 76135 | |
| Australia | |
| Darlinghurst, Australia, NSW 2010 | |
| Enoggera, Australia, QLD 4051 | |
| Heidelbeg West, Australia, VIC 3081 | |
| Kippa-Ring, Australia, QLD 4021 | |
| Mill Park, Australia, VIC 3082 | |
| Toorak Gardens, Australia, SA 5056 | |
Sponsors and Collaborators
Sanofi
Investigators
| Principal Investigator: | Steven G Hull, MD | Vince and Associates Clinical Research |
More Information
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00314132 History of Changes |
| Other Study ID Numbers: | H-040-010 |
| Study First Received: | April 11, 2006 |
| Results First Received: | November 6, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Sanofi:
|
Japanese Encephalitis Encephalitis virus ChimeriVax™-JE Vaccine |
Additional relevant MeSH terms:
|
Encephalitis Encephalitis, Japanese Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Central Nervous System Infections Encephalitis, Arbovirus Arbovirus Infections Encephalitis, Viral RNA Virus Infections Flavivirus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 19, 2013