InfluenzaPhase 3NCT01014091

Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

A Phase 3 study testing GSK pandemic vaccine GSK2340272A in people with Influenza, run by GlaxoSmithKline at 3 sites in Czechia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years. Read more about this study

Who is it for?: Ages 3 to 9 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: GSK pandemic vaccine GSK2340272A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 3 sitesCzechia
Study dates: 1 Dec 2009to 14 Jan 2011
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 9 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
Written informed consent obtained from the parent(s) or LAR(s) of the subject.
Healthy children, as established by medical history and clinical examination when entering the study.

Who cannot join

Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
Clinically or virologically confirmed influenza infection within six months preceding the study start.
Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
Have received any seasonal flu vaccine since last year.
Previous administration of any H1N1 A/California-like vaccine
Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

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Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
History of hypersensitivity to vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurological disorders or seizures.
Acute disease and/or fever at the time of enrolment:
Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38°C on rectal setting.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
Child in Care.

Trial locations and contacts

3 sites in 1 country.

Czechia3 sites

GSK Investigational Site
Děčín, 405 01
GSK Investigational Site
Pardubice, 532 03
GSK Investigational Site
Prague, 1600

Other trials in Czechia

About this study

Official title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 9 Years

The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

Conditions: Influenza
Being tested: GSK pandemic vaccine GSK2340272A
Keywords: influenza infection, GSK Bio's influenza vaccine GSK2340272A
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 pandemic vaccine GSK2340272ABiological
2 intramuscular injections

Study groups in NCT01014091
Study group	Role	What they receive
GSK2340272A F1 Y3-5 GROUP	Experimental	Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule. Receives: Biological: GSK pandemic vaccine GSK2340272A
GSK2340272A F1 Y6-9 GROUP	Experimental	Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule. Receives: Biological: GSK pandemic vaccine GSK2340272A
GSK2340272A F2 Y3-5 GROUP	Experimental	Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule. Receives: Biological: GSK pandemic vaccine GSK2340272A
GSK2340272A F2 Y6-9 GROUP	Experimental	Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule. Receives: Biological: GSK pandemic vaccine GSK2340272A
GSK2340272A F3 Y3-5 GROUP	Experimental	Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule. Receives: Biological: GSK pandemic vaccine GSK2340272A
GSK2340272A F3 Y6-9 GROUP	Experimental	Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule. Receives: Biological: GSK pandemic vaccine GSK2340272A

What is being measured

The primary outcome is the main question the study is designed to answer.

Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Measured: At Day 42
Number of Seropositive Subjects for HI Antibodies
A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Day 42
Number of Seroconverted Subjects in Terms of HI Antibodies
Seroconversion (SCR) was defined as: For initially seronegative subjects [pre-vaccination titer below (<) 1:10], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Day 42
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Day 42
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Day 42

Secondary outcomes (12)

Number of Seropositive Subjects for HI Antibodies
A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Day 0, Day 21 and Month 7
HI Antibody Titers Against Vaccine H1N1 Antigen
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Measured: At Day 0, Day 21 and Month 7
Number of Seroconverted Subjects in Terms of HI Antibodies
Seroconversion (SCR) was defined as: For initially seronegative subjects (pre-vaccination titer below < 1:10), a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Day 21 and Month 7
Number of Seroprotected Subjects for HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Day 0, Day 21 and Month 7
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Measured: At Day 21 and Month 7
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 pain (children below 6 years of age) = cried when limb was moved/spontaneously painful. Grade 3 pain (children above 6 years of age) = significant pain at rest; pain that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the vaccination
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 = symptom which prevented normal everyday activity. Related = symptom assessed by the investigator as causally related to the vaccination. Grade 3 fever = fever > 39.0 °C.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Medically-attended Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: During the entire study period (from Month 0 up to Month 12)
Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)
Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: During the entire study period (from Month 0 up to Month 12)
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: Within the 42-day (Days 0-41) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Month 0 to Month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 200914 Jan 2011

First posted16 Nov 2009 (estimated)
Study start1 Dec 2009
Primary completion14 Jan 2011
Study completion14 Jan 2011

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.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01014091
Sponsor's protocol ID: 113810
Status last verified: May 2018
First submitted: 12 Nov 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza trials

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: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 9 Years
ClinicalTrials.gov ID: NCT01014091
Acronym / sponsor ID: 113810
Conditions: Influenza
Keywords: influenza infection, GSK Bio's influenza vaccine GSK2340272A
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 60 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Dec 2009
Primary completion: 14 Jan 2011 (actual)
Study completion: 14 Jan 2011 (actual)
First posted: 16 Nov 2009 (estimated)
Results: Posted 4 May 2017

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 safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
GSK2340272A F1 Y3-5 GROUP	Experimental	Biological: GSK pandemic vaccine GSK2340272AHealthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F1 Y6-9 GROUP	Experimental	Biological: GSK pandemic vaccine GSK2340272AHealthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F2 Y3-5 GROUP	Experimental	Biological: GSK pandemic vaccine GSK2340272AHealthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F2 Y6-9 GROUP	Experimental	Biological: GSK pandemic vaccine GSK2340272AHealthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F3 Y3-5 GROUP	Experimental	Biological: GSK pandemic vaccine GSK2340272AHealthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F3 Y6-9 GROUP	Experimental	Biological: GSK pandemic vaccine GSK2340272AHealthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Who may qualify

Ages: 3 to 9 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
Written informed consent obtained from the parent(s) or LAR(s) of the subject.
Healthy children, as established by medical history and clinical examination when entering the study.

Key exclusion criteria (17 listed)

Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
Clinically or virologically confirmed influenza infection within six months preceding the study start.
Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
Have received any seasonal flu vaccine since last year.
Previous administration of any H1N1 A/California-like vaccine

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 pandemic vaccine GSK2340272A2 intramuscular injections	Biological	GSK2340272A F1 Y3-5 GROUP, GSK2340272A F1 Y6-9 GROUP, GSK2340272A F2 Y3-5 GROUP, GSK2340272A F2 Y6-9 GROUP, GSK2340272A F3 Y3-5 GROUP, GSK2340272A F3 Y6-9 GROUP

Primary outcome

Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen
Time frame: At Day 42
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Number of Seropositive Subjects for HI Antibodies
Time frame: At Day 42
A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.
Number of Seroconverted Subjects in Terms of HI Antibodies
Time frame: At Day 42
Seroconversion (SCR) was defined as: For initially seronegative subjects [pre-vaccination titer below (<) 1:10], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Number of Seroprotected Subjects for HI Antibodies
Time frame: At Day 42
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
Time frame: At Day 42
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

12 secondary outcomes

Number of Seropositive Subjects for HI Antibodies
Time frame: At Day 0, Day 21 and Month 7
HI Antibody Titers Against Vaccine H1N1 Antigen
Time frame: At Day 0, Day 21 and Month 7
Number of Seroconverted Subjects in Terms of HI Antibodies
Time frame: At Day 21 and Month 7
Number of Seroprotected Subjects for HI Antibodies
Time frame: At Day 0, Day 21 and Month 7
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
Time frame: At Day 21 and Month 7
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Medically-attended Events (MAEs)
Time frame: During the entire study period (from Month 0 up to Month 12)
Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)
Time frame: During the entire study period (from Month 0 up to Month 12)
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: Within the 42-day (Days 0-41) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Month 0 to Month 12)

Results and safety

Results posted to the registry on 4 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK2340272A F1 Y3-5 Group	7	7
GSK2340272A F1 Y6-9 Group	13	13
GSK2340272A F2 Y3-5 Group	5	5
GSK2340272A F2 Y6-9 Group	15	15
GSK2340272A F3 Y3-5 Group	6	6
GSK2340272A F3 Y6-9 Group	12	12

Primary outcome: Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen

Time frame: At Day 42. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	GSK2340272A F1 Group n = 13	GSK2340272A F2 Group n = 9	GSK2340272A F3 Group n = 12
Value	954.6 (730 to 1248.4)	838.1 (647 to 1085.5)	359.1 (219.8 to 586.9)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.

Primary outcome: Number of Seropositive Subjects for HI Antibodies

Time frame: At Day 42. Count of participants. Unit: Participants

Measure	GSK2340272A F1 Group n = 13	GSK2340272A F2 Group n = 9	GSK2340272A F3 Group n = 12
Value	13	9	12

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.

Primary outcome: Number of Seroconverted Subjects in Terms of HI Antibodies

Time frame: At Day 42. Count of participants. Unit: Participants

Measure	GSK2340272A F1 Group n = 13	GSK2340272A F2 Group n = 9	GSK2340272A F3 Group n = 12
Value	13	9	12

Primary outcome: Number of Seroprotected Subjects for HI Antibodies

Time frame: At Day 42. Count of participants. Unit: Participants

Measure	GSK2340272A F1 Group n = 13	GSK2340272A F2 Group n = 9	GSK2340272A F3 Group n = 12
Value	13	9	12

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 21-day (Days 0-20) post-vaccination period. Serious adverse events (SAEs): from Month 0 up to Month 12.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK2340272A F1 Y3-5 Group	0 of 7 (0%)	7 of 7 (100%)	Not reported
GSK2340272A F1 Y6-9 Group	1 of 13 (7.7%)	13 of 13 (100%)	Not reported
GSK2340272A F2 Y3-5 Group	1 of 5 (20%)	4 of 5 (80%)	Not reported
GSK2340272A F2 Y6-9 Group	1 of 15 (6.7%)	15 of 15 (100%)	Not reported
GSK2340272A F3 Y3-5 Group	0 of 6 (0%)	6 of 6 (100%)	Not reported
GSK2340272A F3 Y6-9 Group	1 of 12 (8.3%)	11 of 12 (91.7%)	Not reported

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.
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

3 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 pandemic vaccine GSK2340272A in people with Influenza, run by GlaxoSmithKline at 3 sites in Czechia.

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 4 inclusion and 17 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: stopped early, 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 3 sites in Czechia. 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 4 May 2017). 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?

Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen (time frame: At Day 42). The study lists 5 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 NCT01014091.

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.