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

Phase 2

Completed

Conditions: Influenza

Registration Number: NCT00973349

Lead Sponsor: Novartis

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2719

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age	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.
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age	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.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age	21 days after each vaccination	Geometric mean hemagglutinin inhibition (HI) titer = GMT
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age	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.
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age	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.
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age	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.
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age	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.
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age	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.
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age	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.
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age	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.

Trial Locations

Locations (20): Miami Research Associates
🇺🇸
Miami, Florida, United States
Johnson County Clin-Trials
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Lenexa, Kansas, United States
Meridien Clinical Research
🇺🇸
Omaha, Nebraska, United States
Regional Clinical Research
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Endwell, New York, United States
Rochester Clinical Research, Inc
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Rochester, New York, United States
Triangle Medical Research Associates
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Raleigh, North Carolina, United States
Carolina Medical Trials
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Winston-Salem, North Carolina, United States
Prestige Clinical Research
🇺🇸
Franklin, Ohio, United States
IPS Research
🇺🇸
Oklahoma City, Oklahoma, United States
West Ridge Family Practice (adult)
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Erie, Pennsylvania, United States
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Miami Research Associates
🇺🇸Miami, Florida, United States