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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: MF59-eH1N1_f

• Study Type: Interventional
• Enrollment (Actual): 2719
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Tlalpan, Mexico, 14000
    • Instituto Nacional de Ciencias
• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Miami Research Associates
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clin-Trials
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridien Clinical Research
  • New York
    • Endwell, New York, United States, 13760
      • Regional Clinical Research
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Triangle Medical Research Associates
    • Raleigh, North Carolina, United States, 27609
      • Triangle Medical Research Associates
    • Winston-Salem, North Carolina, United States, 27103
      • Carolina Medical Trials
  • Ohio
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16506
      • West Ridge Family Practice (adult)
    • Jefferson Hills, Pennsylvania, United States, 15025
      • Primary Physicians Research Inc. (adult)
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Clinical Research
  • Texas
    • Dallas, Texas, United States, 75234
      • Research Across America
    • Houston, Texas, United States, 77055
      • West Houston Clinical Research Service
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc./Foothill Family Clinic South
    • Salt Lake City, Utah, United States, 84109
      • J.Lewis Research, Inc./Foothill Family Clinic
  • Virginia
    • Burke, Virginia, United States, 22015
      • Pi-Coor Clinical Research
    • Fairfax, Virginia, United States, 22030
      • PI Coor Clinical Research
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3.75_(50)MF59; 50% of MF59 with 3.75 µg A/H1N1 antigen	Biological: MF59-eH1N1_f; 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 7.5 w/o MF59; 0% of MF59 with 7.5 µg A/H1N1 antigen	Biological: MF59-eH1N1_f; 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 7.5_(50)MF59; 50% of MF59 with 7.5 µg A/H1N1 antigen	Biological: MF59-eH1N1_f; 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 7.5_(100)MF59; 100% of MF59 with 7.5 µg A/H1N1 antigen	Biological: MF59-eH1N1_f; 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 15 w/o MF59; 0% of MF59 with 15 µg A/H1N1 antigen	Biological: MF59-eH1N1_f; 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 15_(50)MF59; 50% of MF59 with 15 µg A/H1N1 antigen	Biological: MF59-eH1N1_f; 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 15_(100)MF59; 100% of MF59 with 15 µg A/H1N1 antigen	Biological: MF59-eH1N1_f; 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Experimental: 30 w/o MF59; 0% of MF59 with 30 µg A/H1N1 antigen	Biological: MF59-eH1N1_f; 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Novartis
• Collaborators: Novartis Vaccines
• Investigators: Study Director: Novartis Vaccine and Diagnostics, Novartis

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: September 2, 2009
• First Submitted That Met QC Criteria: September 7, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Elderly; Vaccine; Adults; Adjuvant; Flu; Swine Flu; Non-Elderly
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V112_01