InfluenzaPhase 3NCT00980005
Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
A Phase 3 study testing GSK investigational vaccine GSK1557482A and Fluzone® in people with Influenza, run by GlaxoSmithKline at 28 sites in United States.
Trial summary
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK investigational vaccine GSK1557482A and Fluzone®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,116 participants
- Where
- 28 sitesUnited States
- Study dates
- 13 Oct 2009to 17 Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
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- 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.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
GSK Investigational Site
Albany, Oregon, 97322
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Austintown, Ohio, 44515
GSK Investigational Site
Benton, Arkansas, 72015
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Burke, Virginia, 22015
GSK Investigational Site
Cary, North Carolina, 27518
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Cortland, New York, 13045
GSK Investigational Site
DeKalb, Illinois, 60115
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Henderson, Nevada, 89015
GSK Investigational Site
Hermitage, Pennsylvania, 16148
GSK Investigational Site
Houston, Texas, 77055
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
Orem, Utah, 84057
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
West Covina, California, 91790
GSK Investigational Site
Wichita, Kansas, 67207
GSK Investigational Site
Woburn, Massachusetts, 01801
GSK Investigational Site
Woodstock, Georgia, 30189
About this study
Official title: Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.
- Conditions
- Influenza
- Being tested
- GSK investigational vaccine GSK1557482A, Fluzone®
- Keywords
- GSK Biologicals influenza vaccine GSK1557482A, influenza infection
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK investigational vaccine GSK1557482ABiological
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
Fluzone®Biological
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
| Study group | Role | What they receive |
|---|---|---|
| Flulaval Group | Experimental | subjects 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. Receives: Biological: GSK investigational vaccine GSK1557482A |
| Fluzone Group | Active comparator | subjects 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. Receives: Biological: Fluzone® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
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).
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Measured: At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
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.
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Measured: At Day 28 after last vaccine dose.
Number of Seroprotected Subjects for 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.
Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.
Measured: At Day 0 and 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Measured: At Day 0 and 28 after last vaccine dose.
Seroconversion Factor (SCF) for 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.
Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.
Measured: At Day 0 and at Day 28 after last vaccine dose
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.
Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Measured: At Day 0 and at Day 28 after last vaccine dose
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).
Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.
Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.
Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.
Related = symptom assessed by the investigator as causally related to the vaccination.
Measured: During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).
Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.
Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.
Related = symptom assessed by the investigator as causaly related to the vaccination.
Measured: During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.
Measured: During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Measured: During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Measured: During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Measured: During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Medically Attended Adverse Events (MAEs).
For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Measured: During the entire study period (From Day 0 up to Day 180).
Number of Subjects Reporting Serious Adverse Events (SAEs).
An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: During the entire study period (From Day 0 up to Day 180).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study start13 Oct 2009
- Primary completion2 Mar 2010
- Study completion17 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,116 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980005
- Sponsor's protocol ID
- 112999
- Status last verified
- Sep 2016
- First submitted
- 17 Sep 2009
- Last updated
- 21 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 29465480Domachowske 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.
PubMed 22333695
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children
- ClinicalTrials.gov ID
- NCT00980005
- Acronym / sponsor ID
- 112999
- Conditions
- Influenza
- Keywords
- GSK Biologicals influenza vaccine GSK1557482A, influenza infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,116 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2009
- Primary completion
- 2 Mar 2010 (actual)
- Study completion
- 17 Jun 2010 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Posted 15 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flulaval Group | Experimental | Biological: GSK investigational vaccine GSK1557482Asubjects 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 comparator | Biological: Fluzone®subjects 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK investigational vaccine GSK1557482AOne intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects | Biological | Flulaval Group |
| Fluzone®One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects | Biological | Fluzone Group |
Primary outcome
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
Time frame: At Day 0 and 28 after last vaccine dose.
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).
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
Time frame: At Day 28 after last vaccine dose.
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.
14 secondary outcomes
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
Time frame: At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
Time frame: At Day 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
Time frame: At Day 0 and 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
Time frame: At Day 0 and 28 after last vaccine dose.
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
Time frame: At Day 0 and at Day 28 after last vaccine dose
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
Time frame: At Day 0 and at Day 28 after last vaccine dose
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Time frame: During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Time frame: During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Time frame: During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Time frame: During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Time frame: During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Time frame: During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Medically Attended Adverse Events (MAEs).
Time frame: During the entire study period (From Day 0 up to Day 180).
Number of Subjects Reporting Serious Adverse Events (SAEs).
Time frame: During the entire study period (From Day 0 up to Day 180).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29465480Li-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.
- Derived from this study: PubMed 22333695Domachowske 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK investigational vaccine GSK1557482A and Fluzone® in people with Influenza, run by GlaxoSmithKline at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. (time frame: At Day 0 and 28 after last vaccine dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00980005, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.