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
Sponsor study identifier
interventional
402
1 country
6
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
August 21, 2013
Actual (reported)August 26, 2013
Actual (reported)September 2014
Actual (reported)September 2014
Actual (reported)May 21, 2015
Actual (reported)Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)
Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
Day 1 and 43
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.
Day 43
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination. Seroconversion is defined as postvaccination HI titer\> 40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum 4-fold increase in titer for subjects with baseline titer \>1:10.
Day 43
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
Day 1 and 43
Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)
Day 1 and 22
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)
Day 22
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Day 22
Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Day 1 and 22.
Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
Day 183 and 366.
H7N9c low dose with adjuvant
H7N9c medium dose with adjuvant
H7N9c high dose with adjuvant
Site 04: Accelovance
San Diego, California, 92108, United States
Site 01: Accelovance
Melbourne, Florida, 32935, United States
Site 02: Accelovance
Peoria, Illinois, 61602, United States
Site 03: Accelovance
Rockville, Maryland, 20850, United States
Site 05: Janet Lewis
Salt Lake City, Utah, 84109, United States
Site 06: Janet Lewis
Salt Lake City, Utah, 84121, United States
Novartis Vaccines and Diagnostics
Novartis Vaccines
402 participants (actual enrollment reported by the registry).
First Submitted
August 21, 2013
First Posted
August 26, 2013
Study Start
August 2013
Date type not reportedThis date has not been verified as actual or estimated.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Day 1 to Day 43
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.
Day 1 to Day 366.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Day 1 through Day 7 after each vaccination.
H7N9c high dose without adjuvant
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 2014
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
June 11, 2019
Results First Posted
May 21, 2015
Record last verified: 2019-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: