Status:
COMPLETED
Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE3
Brief Summary
The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in he...
Eligibility Criteria
Inclusion
- 18 to 49 years of age;
- In good health as determined by medical history and physical examination;
- Able and willing to provide written informed consent prior to any study procedure;
- Able to comply with all study procedures and available for all clinic visits scheduled in the study.
Exclusion
- Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
- Known or suspected impairment/alteration of immune function
- Receipt of an influenza vaccine within 6 months prior to Visit 1;
- Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
- Laboratory-confirmed influenza disease within 6 months prior to Visit 1
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
1507 Patients enrolled
Trial Details
Trial ID
NCT00617851
Start Date
November 1 2007
End Date
June 1 2008
Last Update
May 8 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro de Salud Galvan
Santo Domingo, Dominican Republic
2
Hosp. Nuestra Sra. Altagracia
Santo Domingo, Dominican Republic