Clinical trial NCT00973349: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Influenza
Keywords: Swine Flu
Flu
Vaccine
Adults
Elderly
Non-Elderly
Adjuvant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2009-09-09
Enrollment: 2719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
timeFrame: 21 days after each vaccination
measure: Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
timeFrame: 21 days after each vaccination
Secondary outcomes:
measure: Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
timeFrame: 21 days after each vaccination
measure: Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
timeFrame: 21 days after each vaccination
measure: Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
timeFrame: 21 days after each vaccination
measure: Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
timeFrame: 21 days after vaccination
measure: Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
timeFrame: 7 days after vaccination
measure: Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
timeFrame: 7 days after vaccination
measure: Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
timeFrame: 7 days after vaccination
measure: Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
timeFrame: 7 days after vaccination
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Omaha
country: United States
facility: Meridien Clinical Research
state: Nebraska
city: Endwell
country: United States
facility: Regional Clinical Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Cary
country: United States
facility: Triangle Medical Research Associates
state: North Carolina
city: Raleigh
country: United States
facility: Triangle Medical Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina Medical Trials
state: North Carolina
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Erie
country: United States
facility: West Ridge Family Practice (adult)
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: Primary Physicians Research Inc. (adult)
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Clinical Research
state: Rhode Island
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Salt Lake City
country: United States
facility: J.Lewis Research, Inc./Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc./Foothill Family Clinic South
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research
state: Virginia
city: Fairfax
country: United States
facility: PI Coor Clinical Research
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Ciencias
Study officials:
affiliation: Novartis
name: Novartis Vaccine and Diagnostics
role: STUDY_DIRECTOR
References: