Phase 3
N=2,004
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Encephalitis · Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT00314132 ↗Enrolled (actual)
2,004
Serious AEs
0.4%
Results posted
Dec 2012
Primary outcome: Primary: Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo — 90; 365; 69; 297 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ChimeriVax-JE, Japanese Encephalitis vaccine (Biological); 0.9% Saline (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo |
90; 365; 69; 297; 36; 199 | — |
| PRIMARY Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo |
36; 199; 15; 74; 12; 66 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00314132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.