Pure Global
NCT01928472

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

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
Novartis Vaccines·Phase 1·ClinicalTrials.gov·biologicalCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
H7N9 Influenza
Drug/Device/Intervention
H7N9c low dose with adjuvant
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Novartis Vaccines
Funder
Novartis
Location
San Diego,Melbourne,Peoria,Rockville,Salt Lake City,Salt Lake City, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Aug 01, 2013
End date
Sep 01, 2014
Enrollment
402 participants
Primary outcome

Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43),Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43),Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43),Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43),Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine,Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine,Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine

Summary

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

ICD-10 classifications
Influenza, virus not identifiedHaemophilus influenzae infection, unspecified siteHaemophilus influenzae [H. influenzae] as the cause of diseases classified to other chaptersInfluenza with other manifestations, virus not identifiedInfluenza due to identified seasonal influenza virus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT01928472
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT01928472 through Pure Global AI's free database. This Phase 1 trial is sponsored by Novartis Vaccines and is currently Completed. The study focuses on H7N9 Influenza. Target enrollment is 402 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.