Overview

This trial is active, not recruiting.

Condition h7n9 influenza
Treatments h7n9c low dose with adjuvant, h7n9c medium dose with adjuvant, h7n9c high dose with adjuvant, h7n9c high dose without adjuvant
Phase phase 1
Sponsor Novartis Vaccines
Start date August 2013
End date October 2014
Trial size 400 participants
Trial identifier NCT01928472, V131_01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
H7N9c low dose with adjuvant
h7n9c low dose with adjuvant
(Experimental)
H7N9c medium dose with adjuvant
h7n9c medium dose with adjuvant
(Experimental)
H7N9c high dose with adjuvant
h7n9c high dose with adjuvant
(Experimental)
H7N9c high dose without adjuvant
h7n9c high dose without adjuvant

Primary Outcomes

Measure
Geometric Mean Titre (GMT), Geometric Mean Ration (GMR) and percentage of subjects achieving seroconversion
time frame: Day 1 and 43
Percentage of subjects with solicited local adverse events
time frame: Day 1-7
Percentage of subjects with solicited systematic adverse events
time frame: Day 22-29
Percentage of subjects with unsolicited adverse events and percentage of subjects with serious adverse events
time frame: Day 1-336

Secondary Outcomes

Measure
GMT, GMR and percentage of subjects achieving seroconversion by HI
time frame: Day 1, 22, 183, 366
GMT, GMR and percentage of subjects achieving seroconversion by MN
time frame: Day 1, 22, 43, 183, 366

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

Inclusion Criteria: 1. Healthy adult subject ages 18-64 years. 2. Individuals willing to provide written informed consent 3. Individuals in good health. 4. Individuals who can comply with study procedures and follow-up. Exclusion Criteria: 1. Individuals with history of cognitive or behavioral impairment or psychiatric disease, 2. Individuals unable to understand and follow study procedures, 3. History of significant illness, 4. History of chronic medical condition or progressive disease, 5. Allergy to any vaccine component or adverse event related to a vaccine component, 6. Impairment/alteration of the immune system, 7. Presence of progressive or severe neurological disorder, 8. Pregnant or breast-feeding, 9. Female of Child-bearing potential unwilling to use acceptable method of birth control, 10. Presence of medically significant cancer, 11. Receipt of investigational product within 30 day prior to entry into the study, 12. History of previous or suspected illness from avian flu caused by H7N9 virus, 13. History of H7 vaccination, 14. 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, 15. Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination, 16. Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination, 17. History of drug or alcohol abuse within the past 2 years, 18. Body Mass Index (BMI) greater than or equal to 35kg/m2, 19. Individuals conducting the study or their immediate family members.

Additional Information

Official title Phase I Multi-center, Observer-Blind, Randomized Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated A/H7N9 Monovalent Subunit Influenza Virus Vaccine (H7N9c) in Adults 18 to <65 Years
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Novartis.