Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00617851
• Date of registration: 06/02/2008
• Primary sponsor: Novartis Vaccines
• Public title: Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
• Scientific title: A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years
• Date of first enrolment: November 2007
• Target sample size: 1507
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00617851
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Countries of recruitment

Dominican Republic

Contacts

• Name: Novartis Vaccines and Diagnostics
• Affiliation: Novartis

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 49 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: All 3 consecutive lots of influenza virus vaccine pooled

Biological: Comparator influenza virus vaccine

Biological: Lot A of Influenza virus vaccine

Biological: Lot B of Influenza virus vaccine

Biological: Lot C of Influenza virus vaccine

Primary Outcome(s)

Geometric Mean Titers (GMTs), by Vaccine Lots [Time Frame: 21 days after vaccination]

Secondary Outcome(s)

Geometric Mean Titers (GMTs), by Vaccine Group and Strain [Time Frame: 21 days after vaccination]

Number of Subjects Reporting Solicited Local and Systemic Symptoms [Time Frame: 7 days after vaccination]

Number of Subjects With at Least One Unsolicited Adverse Event [Time Frame: 3 weeks after vaccination]

Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1) [Time Frame: 21 days after vaccination]

Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2) [Time Frame: 21 days after vaccination]

Percentage of Subjects With Seroprotection and Seroconversion (Strain B) [Time Frame: 21 days after vaccination]

Secondary ID(s)

13299

V71P6

Source(s) of Monetary Support

Please refer to primary and secondary sponsors