Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

Influenza Clinical Trial

Official title:

A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973349
• Other study ID #: V112_01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 2, 2009
• Last updated: October 29, 2015
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2719
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion Criteria:

• History of serious disease.

• History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.

• Known or suspected impairment/alteration of immune function.

• Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.

• Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.

• For additional entry criteria, please refer to protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias	Tlalpan
United States	PI-Coor Clinical Research	Burke	Virginia
United States	Triangle Medical Research Associates	Cary	North Carolina
United States	Research Across America	Dallas	Texas
United States	Regional Clinical Research	Endwell	New York
United States	West Ridge Family Practice (adult)	Erie	Pennsylvania
United States	PI Coor Clinical Research	Fairfax	Virginia
United States	Prestige Clinical Research	Franklin	Ohio
United States	West Houston Clinical Research Service	Houston	Texas
United States	Primary Physicians Research Inc. (adult)	Jefferson Hills	Pennsylvania
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Miami Research Associates	Miami	Florida
United States	IPS Research	Oklahoma City	Oklahoma
United States	Meridien Clinical Research	Omaha	Nebraska
United States	Triangle Medical Research Associates	Raleigh	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	J. Lewis Research, Inc./Foothill Family Clinic South	Salt Lake City	Utah
United States	J.Lewis Research, Inc./Foothill Family Clinic	Salt Lake City	Utah
United States	Omega Clinical Research	Warwick	Rhode Island
United States	Carolina Medical Trials	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age	Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer =1:40.	21 days after each vaccination	No
Primary	Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants =65 Years of Age	Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer =1:40.	21 days after each vaccination	No
Secondary	Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and =65 Years of Age	Geometric mean hemagglutinin inhibition (HI) titer = GMT	21 days after each vaccination	No
Secondary	Number of Subjects With Seroconversion and With HI =1:40, in Participants 18 to 60 Years of Age	Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer =1:40.	21 days after each vaccination	No
Secondary	Number of Subjects With Seroconversion and With HI =1:40, in Participants =61 Years of Age	Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer =1:40.	21 days after each vaccination	No
Secondary	Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and =61 Years of Age	Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.	21 days after vaccination	No
Secondary	Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age	Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.	7 days after vaccination	Yes
Secondary	Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age	Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.	7 days after vaccination	Yes
Secondary	Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants =65 Years of Age	Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.	7 days after vaccination	Yes
Secondary	Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants =65 Years of Age	Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.	7 days after vaccination	Yes