Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children
1 other identifier
interventional
2,116
1 country
28
Brief Summary
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2009
Shorter than P25 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2009
CompletedFirst Posted
Study publicly available on registry
September 18, 2009
CompletedStudy Start
First participant enrolled
October 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2010
CompletedResults Posted
Study results publicly available
February 15, 2012
CompletedSeptember 21, 2018
September 1, 2016
5 months
September 17, 2009
January 20, 2012
August 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
At Day 28 after last vaccine dose.
Secondary Outcomes (14)
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
At Day 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
At Day 0 and 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
At Day 0 and 28 after last vaccine dose.
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
At Day 0 and at Day 28 after last vaccine dose
- +9 more secondary outcomes
Study Arms (2)
Flulaval Group
EXPERIMENTALsubjects received Flulaval™ vaccine according to their priming status and age: * 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 * 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
Fluzone Group
ACTIVE COMPARATORsubjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age: * 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28 * 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
Interventions
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
Eligibility Criteria
You may qualify if:
- Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
- A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
- Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
You may not qualify if:
- Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
- Child in care
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- History of hypersensitivity to any vaccine.
- History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Acute disease and/or fever at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (28)
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Benton, Arkansas, 72015, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
West Covina, California, 91790, United States
GSK Investigational Site
Marietta, Georgia, 30062, United States
GSK Investigational Site
Woodstock, Georgia, 30189, United States
GSK Investigational Site
DeKalb, Illinois, 60115, United States
GSK Investigational Site
Newton, Kansas, 67114, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Woburn, Massachusetts, 01801, United States
GSK Investigational Site
Stevensville, Michigan, 49127, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Henderson, Nevada, 89015, United States
GSK Investigational Site
Cortland, New York, 13045, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Cary, North Carolina, 27518, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Austintown, Ohio, 44515, United States
GSK Investigational Site
Albany, Oregon, 97322, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Hermitage, Pennsylvania, 16148, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Houston, Texas, 77055, United States
GSK Investigational Site
Orem, Utah, 84057, United States
GSK Investigational Site
Provo, Utah, 84604, United States
GSK Investigational Site
Burke, Virginia, 22015, United States
Related Publications (2)
Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.
PMID: 29465480DERIVEDDomachowske JB, Blatter M, Chandrasekaran V, Liu A, Jain VK, Fries L. A randomized, controlled trial in children to assess the immunogenicity and safety of a thimerosal-free trivalent seasonal influenza vaccine. Pediatr Infect Dis J. 2012 Jun;31(6):605-15. doi: 10.1097/INF.0b013e31824e2924.
PMID: 22333695DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2009
First Posted
September 18, 2009
Study Start
October 13, 2009
Primary Completion
March 2, 2010
Study Completion
June 17, 2010
Last Updated
September 21, 2018
Results First Posted
February 15, 2012
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.