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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MF59-eH1N1_f
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Swine Flu, Flu, Vaccine, Adults, Elderly, Non-Elderly, Adjuvant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Miami Research Associates
  • Johnson County Clin-Trials
  • Meridien Clinical Research
  • Regional Clinical Research
  • Rochester Clinical Research, Inc
  • Triangle Medical Research Associates
  • Triangle Medical Research Associates
  • Carolina Medical Trials
  • Prestige Clinical Research
  • IPS Research
  • West Ridge Family Practice (adult)
  • Primary Physicians Research Inc. (adult)
  • Omega Clinical Research
  • Research Across America
  • West Houston Clinical Research Service
  • J.Lewis Research, Inc./Foothill Family Clinic
  • J. Lewis Research, Inc./Foothill Family Clinic South
  • PI-Coor Clinical Research
  • PI Coor Clinical Research
  • Virginia Commonwealth University
  • Instituto Nacional de Ciencias

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

3.75_(50)MF59

7.5 w/o MF59

7.5_(50)MF59

7.5_(100)MF59

15 w/o MF59

15_(50)MF59

15_(100)MF59

30 w/o MF59

Arm Description

50% of MF59 with 3.75 µg A/H1N1 antigen

0% of MF59 with 7.5 µg A/H1N1 antigen

50% of MF59 with 7.5 µg A/H1N1 antigen

100% of MF59 with 7.5 µg A/H1N1 antigen

0% of MF59 with 15 µg A/H1N1 antigen

50% of MF59 with 15 µg A/H1N1 antigen

100% of MF59 with 15 µg A/H1N1 antigen

0% of MF59 with 30 µg A/H1N1 antigen

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 2, 2009
Last Updated
October 29, 2015
Sponsor
Novartis
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00973349
Brief Title
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Swine Flu, Flu, Vaccine, Adults, Elderly, Non-Elderly, Adjuvant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2719 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3.75_(50)MF59
Arm Type
Experimental
Arm Description
50% of MF59 with 3.75 µg A/H1N1 antigen
Arm Title
7.5 w/o MF59
Arm Type
Experimental
Arm Description
0% of MF59 with 7.5 µg A/H1N1 antigen
Arm Title
7.5_(50)MF59
Arm Type
Experimental
Arm Description
50% of MF59 with 7.5 µg A/H1N1 antigen
Arm Title
7.5_(100)MF59
Arm Type
Experimental
Arm Description
100% of MF59 with 7.5 µg A/H1N1 antigen
Arm Title
15 w/o MF59
Arm Type
Experimental
Arm Description
0% of MF59 with 15 µg A/H1N1 antigen
Arm Title
15_(50)MF59
Arm Type
Experimental
Arm Description
50% of MF59 with 15 µg A/H1N1 antigen
Arm Title
15_(100)MF59
Arm Type
Experimental
Arm Description
100% of MF59 with 15 µg A/H1N1 antigen
Arm Title
30 w/o MF59
Arm Type
Experimental
Arm Description
0% of MF59 with 30 µg A/H1N1 antigen
Intervention Type
Biological
Intervention Name(s)
MF59-eH1N1_f
Intervention Description
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Primary Outcome Measure Information:
Title
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Description
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.
Time Frame
21 days after each vaccination
Title
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Description
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.
Time Frame
21 days after each vaccination
Secondary Outcome Measure Information:
Title
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Description
Geometric mean hemagglutinin inhibition (HI) titer = GMT
Time Frame
21 days after each vaccination
Title
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Description
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.
Time Frame
21 days after each vaccination
Title
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Description
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.
Time Frame
21 days after each vaccination
Title
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Description
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
Time Frame
21 days after vaccination
Title
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Description
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time Frame
7 days after vaccination
Title
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Description
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time Frame
7 days after vaccination
Title
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Description
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time Frame
7 days after vaccination
Title
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Description
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time Frame
7 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccine and Diagnostics
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Meridien Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Regional Clinical Research
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Triangle Medical Research Associates
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Triangle Medical Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Carolina Medical Trials
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
West Ridge Family Practice (adult)
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Primary Physicians Research Inc. (adult)
City
Jefferson Hills
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Facility Name
Omega Clinical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
West Houston Clinical Research Service
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
J.Lewis Research, Inc./Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc./Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
PI-Coor Clinical Research
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
PI Coor Clinical Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Instituto Nacional de Ciencias
City
Tlalpan
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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