Last updated: 11/07/2018 00:43:26
Study comparing the immune response and safety of Fluarix and Fluzone influenza vaccines in children
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase III, single-blind, randomized study to evaluate the immunogenicity and safety of Fluarix® (GSK Biologicals') compared with Fluzone® (Aventis Pasteur/Sanofi) administered intramuscularly in children (6 months and older)
Trial description: The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Geometric mean titer (GMT) of serum haemagglutination-inhibition (HI) antibodies
Timeframe: 21 or 28 days after last vaccine dose
Number of seroconverted subjects
Timeframe: 21 or 28 days after last vaccine dose
Number of subjects reporting rare serious events
Timeframe: Up to 6 months after vaccination
Secondary outcomes:
Number of seroprotected subjects
Timeframe: Before (PRE) and 21 or 28 days after (POST) the last vaccine dose
Number of initially unprotected subjects with at least a 4 fold increase in HI titer
Timeframe: 21 or 28 days after last vaccine dose
Number of subjects reporting solicited local and general symptoms
Timeframe: During a 4-day follow-up period after each vaccination
Number of subjects reporting unsolicited adverse events
Timeframe: Within 28 days following vaccination
Number of subjects reporting new onset chronic illnesses and/or serious adverse events (SAE)
Timeframe: Up to 6 months after vaccination
Interventions:
Enrollment:
3327
Primary completion date:
2007-19-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Baxter R et al. (2010) A phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children. Pediatr Infect Dis J. 29(10):924-930.
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
November 2006 to October 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 months - 17 years
Accepts healthy volunteers
Yes
- A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
- Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
- History of hypersensitivity to any vaccine.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
- Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the subject’s parent/guardian; assent obtained in subjects > 10 years.
- Female subjects of childbearing potential must agree to take a pregnancy test.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
- History of hypersensitivity to any vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrollment. -History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Pregnant or lactating female.
- Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.
Trial location(s)
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Pleasanton, California, United States, 94588
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Location
GSK Investigational Site
Santa Rosa, California, United States, 95403
Status
Study Complete
Location
GSK Investigational Site
San Angelo, Texas, United States, 76904
Status
Study Complete
Showing 1 - 6 of 40 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2007-19-10
Actual study completion date
2007-19-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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