Clinical trial NCT00996307: Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Official title: Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Influenza
Keywords: Swine Flu
Flu
Vaccine
Children
Adjuvant
A/H1N1 2009 Influenza
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2009-10-16
Enrollment: 654
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
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 2009 (swine flu) vaccine in healthy young children


Eligibility criteria: Inclusion Criteria:

* Children 6 to 35 months 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 After the First and Second Vaccinations
timeFrame: 21 days after each vaccination
measure: Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
timeFrame: Day 1 to 7
measure: Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
timeFrame: Day 22 to 28
Secondary outcomes:
measure: Immunogenicity Measurement by Geometric Mean Titers (GMT)
timeFrame: 21 days after each vaccination
measure: Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
timeFrame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
measure: Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
timeFrame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
measure: Antibody Response Based on Baseline Seropositivity
timeFrame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
measure: Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
timeFrame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
measure: Antibody Persistence by Geometric Mean Titers (GMT)
timeFrame: 6 months (Day 202) and 12 months (Day 387) after second vaccination
Other outcomes:
Locations:
city: Bentonville
country: United States
state: Arkansas
city: Fort Smith
country: United States
state: Arkansas
city: Canoga Park
country: United States
state: California
city: Dinuba
country: United States
state: California
city: Fresno
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Madera
country: United States
state: California
city: Torrance
country: United States
state: California
city: New Albany
country: United States
state: Indiana
city: Newton
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Woburn
country: United States
state: Massachusetts
city: Fargo
country: United States
state: North Dakota
city: Dayton
country: United States
state: Ohio
city: Huber Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Charleston
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Lebanon
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Provo
country: United States
state: Utah
city: Saint George
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Delegacion Tlalpan
country: Mexico
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_DIRECTOR
References: