Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years

Completed · Phase 1

Conditions studied: H7N9 Influenza

In brief

Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.

Key facts

Study ID

NCT01928472

Run by

Novartis Vaccines

People needed

402

Starts

2013-08-01

Expected to finish

2014-09-01

Last updated by the study team

2019-06-11

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult subject ages 18-64 years.
• Individuals willing to provide written informed consent
• Individuals in good health.
• Individuals who can comply with study procedures and follow-up.

You may not qualify if…

• Individuals with history of cognitive or behavioral impairment or psychiatric disease,
• Individuals unable to understand and follow study procedures,
• History of significant illness,
• History of chronic medical condition or progressive disease,
• Allergy to any vaccine component or adverse event related to a vaccine component,
• Impairment/alteration of the immune system,
• Presence of progressive or severe neurological disorder,
• Pregnant or breast-feeding,
• Female of Child-bearing potential unwilling to use acceptable method of birth control,
• Presence of medically significant cancer,
• Receipt of investigational product within 30 day prior to entry into the study,
• History of previous or suspected illness from avian flu caused by H7N9 virus,
• History of H7 vaccination,
• Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination,
• Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination,
• Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination,
• History of drug or alcohol abuse within the past 2 years,
• Body Mass Index (BMI) greater than or equal to 35kg/m2,
• Individuals conducting the study or their immediate family members.

Where it is running

• Site 04: Accelovance — San Diego, California, United States
• Site 01: Accelovance — Melbourne, Florida, United States
• Site 02: Accelovance — Peoria, Illinois, United States
• Site 03: Accelovance — Rockville, Maryland, United States
• Site 05: Janet Lewis — Salt Lake City, Utah, United States
• Site 06: Janet Lewis — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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