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

October 29, 2015 updated by: Novartis

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2719

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 21 days after each vaccination
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
Time Frame: 21 days after each vaccination
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
Time Frame: 21 days after each vaccination
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
Time Frame: 21 days after each vaccination
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
Time Frame: 21 days after each vaccination
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
Time Frame: 21 days after vaccination
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
Time Frame: 7 days after vaccination
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
Time Frame: 7 days after vaccination
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
Time Frame: 7 days after vaccination
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
Time Frame: 7 days after vaccination
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

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Novartis Vaccines

Investigators

  • Study Director: Novartis Vaccine and Diagnostics, Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V112_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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