Who is sponsoring NCT01928472?

NCT01928472 is sponsored by Novartis Vaccines.

What condition does NCT01928472 study?

NCT01928472 studies H7N9 Influenza.

What drugs are being tested in NCT01928472?

Interventions: H7N9c low dose with adjuvant, H7N9c medium dose with adjuvant, H7N9c high dose with adjuvant, H7N9c high dose without adjuvant.

What is the status of NCT01928472?

NCT01928472 is currently COMPLETED.

Last reviewed 2019-05-28 · How we verify

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

NCT01928472 Phase 1 COMPLETED Results posted

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

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 1
Status	COMPLETED
Enrolment	402
Start date	2013-08
Completion	2014-09

Conditions

H7N9 Influenza

Interventions

H7N9c low dose with adjuvant
H7N9c medium dose with adjuvant
H7N9c high dose with adjuvant
H7N9c high dose without adjuvant

Primary outcomes

Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) — Day 1 and 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
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43) — 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.
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) — 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.
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) — Day 1 and 43
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine — Day 1 to Day 43
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.
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine — Day 1 to Day 366.
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.

Countries

United States