Clinical trial NCT00972816: Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
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 Pediatric Subjects 3 to < 9 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Influenza
Keywords: Swine Flu
Flu
Vaccine
Children
Adjuvant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 1357
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
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 healthy young children.


Eligibility criteria: Inclusion Criteria:

* Children 3 to \< 9 years of age 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.

For additional entry criteria, please refer to protocol.

Primary outcomes:
measure: Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
timeFrame: Day 22, Day 29, Day 43, Day 202 and Day 387
Secondary outcomes:
measure: Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
timeFrame: Day 22, Day 29, Day 43, Day 202 and Day 387
measure: Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
timeFrame: Day 22, Day 29, Day 43
measure: Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
timeFrame: Day 1, Day 22, Day 29, Day 43
measure: Antibody Response Based on Baseline Seropositivity
timeFrame: Day 22, Day 29 and Day 43
measure: Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
timeFrame: Day 1, Day 22, Day 29, Day 43
measure: Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
timeFrame: 7 days after first vaccination
measure: Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
timeFrame: 7 days after second vaccination
measure: Number of Participants Reporting Unsolicited Adverse Events (AEs)
timeFrame: Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination
Other outcomes:
Locations:
city: Downey
country: United States
facility: Premier Health Research Center, LLC
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Paramount
country: United States
facility: Center for Clincal Trials, LLC
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: West Covina
country: United States
facility: Center for Clinical Trials of San Gabriel
state: California
city: Thornton
country: United States
facility: 1st International Research Centers
state: Colorado
city: Marietta
country: United States
facility: Pediatrics and Adolescent Medicine
state: Georgia
city: Woodstock
country: United States
facility: Pediatrics and Adolescent Medicine
state: Georgia
city: Dekalb
country: United States
facility: Northern Illinois Research Associates
state: Illinois
city: New Albany
country: United States
facility: Bluegrass Clinical Research, Inc.
state: Indiana
city: Arkansas City
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates LLC
state: Kansas
city: Louisville
country: United States
facility: Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)
state: Kentucky
city: Omaha
country: United States
facility: Meridien Clinical Research
state: Nebraska
city: Henderson
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Raleigh
country: United States
facility: Capital Pediatrics and Adolescent Ctr.
state: North Carolina
city: Cleveland
country: United States
facility: Dr. Senders and Associates, Pediatrics
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Beaverton
country: United States
facility: The Portland Clinic LLP
state: Oregon
city: Erie
country: United States
facility: Children's Health Care -West
state: Pennsylvania
city: Greenville
country: United States
facility: UPMC/Community Medicine (pediatrics)
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: Pediatric Physicians Research, Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance - Greentree Division (pediatrics)
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Clinical Research
state: Rhode Island
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
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: Tomball
country: United States
facility: Pediatric Healthcare of NW Houston
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: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Spokane
country: United States
facility: Rockwood Research Center
state: Washington
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Ciencias
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_DIRECTOR
References: