InfluenzaPhase 3NCT00319098

Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

A Phase 3 study testing Adjuvanted pandemic influenza candidate vaccine and Fluarix in people with Influenza, run by GlaxoSmithKline at 40 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Adjuvanted pandemic influenza candidate vaccine and Fluarix
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5,075 participants
Where: 40 sitesin 7 countries
Study dates: 1 May 2006to 31 Jul 2007
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A male or female aged 18 years or above at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Who cannot join

Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination.
Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
History of chronic alcohol consumption and/or drug abuse.
History of hypersensitivity to vaccines.

Show all 13Show fewer

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the study vaccine or during the study.
Lactating women
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.

Trial locations and contacts

40 sites in 7 countries.

Country

City, postcode or hospital

40 sites in 7 countries

Germany15 sites

GSK Investigational Site
Berlin, 10117
GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 14057
GSK Investigational Site
Dresden, Saxony, 01067
GSK Investigational Site
Hamburg, 20249
GSK Investigational Site
Hamburg, 22143
GSK Investigational Site
Hanover, Lower Saxony, 30519
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Leipzig, Saxony, 04229
GSK Investigational Site
Munich, Bavaria, 80799
GSK Investigational Site
Munich, Bavaria, 81667
GSK Investigational Site
Regensburg, Bavaria, 93053
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455
GSK Investigational Site
Würzburg, Bavaria, 97070

Other trials in Germany

Spain8 sites

GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Marid, 28040
GSK Investigational Site
Valencia, 46014
GSK Investigational Site
Valencia, 46017

Other trials in Spain

France6 sites

GSK Investigational Site
Caen, 14052
GSK Investigational Site
Lagord, 17140
GSK Investigational Site
Nantes, 44093
GSK Investigational Site
Paris, 75877
GSK Investigational Site
Poitiers, 86000
GSK Investigational Site
Rouen, 76100

Other trials in France

Russia5 sites

GSK Investigational Site
Kazan', 420015
GSK Investigational Site
Novokuznetsk, 654063
GSK Investigational Site
Saratov
GSK Investigational Site
Yekaterinburg, 620028
GSK Investigational Site
Yekaterinburg, 620078

Other trials in Russia

Estonia2 sites

GSK Investigational Site
Tallinn, 10617
GSK Investigational Site
Tartu, 50417

Other trials in Estonia

Netherlands2 sites

GSK Investigational Site
Rotterdam, 3011 EN
GSK Investigational Site
Rotterdam, 3015 GE

Other trials in Netherlands

Sweden2 sites

GSK Investigational Site
Eskilstuna, SE-631 88
GSK Investigational Site
Stockholm, SE-141 86

Other trials in Sweden

About this study

Official title: A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older

Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

Read the detailed description

This study has 2 phases:

The study ID 107064 corresponds to objectives \& outcome measures evaluated from day 0 until day 51.

The study ID 107217 corresponds to objectives \& outcome measures evaluated at day 180.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions: Influenza
Being tested: Adjuvanted pandemic influenza candidate vaccine, Fluarix, Placebo
Keywords: Adjuvanted pandemic influenza candidate vaccine, Influenza
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adjuvanted pandemic influenza candidate vaccineBiological
2 doses, intramuscular injection
FluarixBiological
One intramuscular injection
PlaceboBiological
One intramuscular injection

Study groups in NCT00319098
Study group	Role	What they receive
GSK1562902A Group	Experimental	Male and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses. Receives: Biological: Adjuvanted pandemic influenza candidate vaccine
Fluarix+Placebo Group	Active comparator	Male and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses. Receives: Biological: Fluarix; Biological: Placebo

What is being measured

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

Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter
Measured: During a 7 day follow-up period after each dose of vaccine and overall.
Number of Subjects With Solicited General Symptoms (Dose 1)
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Measured: During the 7-day (Days 0-6) after Dose 1
Number of Subjects With Solicited General Symptoms (Dose 2)
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Measured: During the 7-day (Days 0-6) after Dose 2
Number of Subjects With Solicited General Symptoms (Across Doses)
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Measured: During the 7-day (Days 0-6) post vaccination across dosses
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. Related symptoms were not available.
Measured: During the 21st Day (Days 0-20) post Dose 1
Number of Subjects With 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. Related symptoms were not available.
Measured: During the 30 Day (Days 0-29) post Dose 2
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Day 0 to Day 180
Number of Subjects With New Onset Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From Day 0 to Day 180
Number of Subjects With Medically Significant Conditions (MSCs)
MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Measured: From Day 0 to Day 51

Secondary outcomes (4)

Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
Anti-HA antibody titers were expressed as Geometric Mean Tiyers (GMTs).
Measured: At Day 0 (PRE), 21 and 42
Number of Seroconverted Subjects Against H5N1
Seroconversion rate for Haemagglutinin antibody response was defined as the number of vaccinees who had either a pre-vaccination titer lower than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a fourfold increase in post-vaccination titer. Seroconversion rate for Neutralising antibody response was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination.
Measured: At Day 21 and Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to day 0.
Measured: At Day 21 and Day 42
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
Seroprotection rate was defined as the number of vaccinees with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
Measured: At Day 0 (PRE), Day 21 and Day 42

Timeline

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

1 May 200631 Jul 2007

First posted27 Apr 2006 (estimated)
Study start1 May 2006
Primary completion1 Jan 2007
Study completion31 Jul 2007

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 (1)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, Outcomes assessor
Enrolment: 5,075 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00319098
Sponsor's protocol ID: 107064
Other IDs: 107217
Status last verified: Apr 2017
First submitted: 26 Apr 2006
Last updated: 23 Jul 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

Rumke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Drame M, Sanger R, Ballou WR. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine. 2008 May 2;26(19):2378-88. doi: 10.1016/j.vaccine.2008.02.068. Epub 2008 Mar 27.
PubMed 18407382

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?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older
ClinicalTrials.gov ID: NCT00319098
Acronym / sponsor ID: 107064
Conditions: Influenza
Keywords: Adjuvanted pandemic influenza candidate vaccine, Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,075 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 May 2006 (actual)
Primary completion: 1 Jan 2007 (actual)
Study completion: 31 Jul 2007 (actual)
First posted: 27 Apr 2006 (estimated)
Results: Posted 3 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study has 2 phases:

The study ID 107064 corresponds to objectives \& outcome measures evaluated from day 0 until day 51.

The study ID 107217 corresponds to objectives \& outcome measures evaluated at day 180.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
GSK1562902A Group	Experimental	Biological: Adjuvanted pandemic influenza candidate vaccineMale and female subjects aged 18 or over received two intramuscular doses of the GSK1562902A study vaccine, at Day 0 and Day 21, into the non-dominant arm. The group was further stratified by age for analyses.
Fluarix+Placebo Group	Active comparator	Biological: Fluarix, Biological: PlaceboMale and female subjects aged 18 or over received one dose of Fluarix™ vaccine at Day 0 and one dose of placebo at Day 21, intramuscularly into de non-dominant arm. The group was further stratified by age for analyses.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
A male or female aged 18 years or above at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
If the subject is female, she must be of non-childbearing potential, for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Key exclusion criteria (13 listed)

Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination.
Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual interpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first administration of the study vaccine.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
History of chronic alcohol consumption and/or drug abuse.

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
Adjuvanted pandemic influenza candidate vaccine2 doses, intramuscular injection	Biological	GSK1562902A Group
FluarixOne intramuscular injection	Biological	Fluarix+Placebo Group
PlaceboOne intramuscular injection	Biological	Fluarix+Placebo Group

Primary outcome

Number of Subjects With Solicited Local Symptoms
Time frame: During a 7 day follow-up period after each dose of vaccine and overall.
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal everyday activities Grade 3 ecchymosis/induration/redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) in diameter
Number of Subjects With Solicited General Symptoms (Dose 1)
Time frame: During the 7-day (Days 0-6) after Dose 1
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Number of Subjects With Solicited General Symptoms (Dose 2)
Time frame: During the 7-day (Days 0-6) after Dose 2
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Number of Subjects With Solicited General Symptoms (Across Doses)
Time frame: During the 7-day (Days 0-6) post vaccination across dosses
Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, myalgia, shivering, sweating. Any = occurrence of symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 Fever = fever higher than (>) 39.0 °C. Related = symptom considered by the investigator to be casually related with the study vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 21st Day (Days 0-20) post Dose 1
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. Related symptoms were not available.
Number of Subjects With AEs
Time frame: During the 30 Day (Days 0-29) post Dose 2
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. Related symptoms were not available.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 to Day 180
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With New Onset Chronic Diseases (NOCDs)
Time frame: From Day 0 to Day 180
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects With Medically Significant Conditions (MSCs)
Time frame: From Day 0 to Day 51
MSCs prompting emergency room or physician visits that were not related to common diseases or routine visits. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

4 secondary outcomes

Anti- Haemagglutinin Antibody (Anti-HA) Titers Against Avian Influenza A Subtype H5N1
Time frame: At Day 0 (PRE), 21 and 42
Number of Seroconverted Subjects Against H5N1
Time frame: At Day 21 and Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam Influenza Strain
Time frame: At Day 21 and Day 42
Number of Seroprotected Subjects Against A/Vietnam Influenza Strain
Time frame: At Day 0 (PRE), Day 21 and Day 42

Results and safety

Results posted to the registry on 3 Aug 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
GSK1562902A Group	3,802	3,667
Fluarix+Placebo Group	1,269	1,237

Primary outcome: Number of Subjects With Solicited Local Symptoms

Time frame: During a 7 day follow-up period after each dose of vaccine and overall.. Count of participants. Unit: Participants

Measure	GSK1562902A 18-60 YOA Group n = 3343	GSK1562902A >60 YOA Group n = 403	Fluarix+Placebo 18-60 YOA Group n = 1123	Fluarix+Placebo >60 YOA Group n = 133
Any Ecchymosis, Dose 1 [N=3342;403;1123;133]	212	16	39	3
Grade 3 Ecchymosis, Dose 1[N=3342;403;1123;133]	8	1	0	0
Any Induration, Dose 1[N=3342;403;1123;133]	876	73	199	17
Grade 3 Induration, Dose 1[N=3342;403;1123;133]	96	6	10	0
Any Pain, Dose 1[N=3342;403;1123;133]	2926	233	724	36
Grade 3 Pain, Dose 1[N=3342;403;1123;133]	169	3	6	0
Any Redness, Dose 1[N=3342;403;1123;133]	910	112	281	34
Grade 3 Redness, Dose 1[N=3342;403;1123;133]	128	12	17	0

Population analysed: The analysis was performed on the Total Vaccinated cohort (TVc) which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.

Primary outcome: Number of Subjects With Solicited General Symptoms (Dose 1)

Time frame: During the 7-day (Days 0-6) after Dose 1. Count of participants. Unit: Participants

Measure	GSK1562902A 18-60 YOA Group n = 3341	GSK1562902A >60 YOA Group n = 403	Fluarix+Placebo 18-60 YOA Group n = 1123	Fluarix+Placebo >60 YOA Group n = 133
Any Arthralgia, Dose 1	625	57	100	13
Grade 3 Arthralgia, Dose 1	47	1	3	1
Related Arthralgia, Dose 1	583	46	86	11
Any Fatigue, Dose 1	1384	80	284	20
Grade 3 Fatigue, Dose 1	90	3	4	2
Related Fatigue, Dose 1	1220	67	235	15
Any Fever, Dose 1	270	10	24	6
Grade 3 Fever, Dose 1	7	0	0	0

Population analysed: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.

Primary outcome: Number of Subjects With Solicited General Symptoms (Dose 2)

Time frame: During the 7-day (Days 0-6) after Dose 2. Count of participants. Unit: Participants

Measure	GSK1562902A 18-60 YOA Group n = 3246	GSK1562902A >60 YOA Group n = 395	Fluarix+Placebo 18-60 YOA Group n = 1102	Fluarix+Placebo >60 YOA Group n = 132
Any Arthralgia, Dose 2	513	47	41	6
Grade 3 Arthralgia, Dose 2	46	3	2	0
Related Arthralgia, Dose 2	493	39	34	4
Any Fatigue, Dose 2	1108	77	148	14
Grade 3 Fatigue, Dose 2	81	2	5	1
Related Fatigue, Dose 2	1014	66	119	12
Any Fever, Dose 2	278	16	15	5
Grade 3 Fever, Dose 2	10	1	0	0

Population analysed: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.

Primary outcome: Number of Subjects With Solicited General Symptoms (Across Doses)

Time frame: During the 7-day (Days 0-6) post vaccination across dosses. Count of participants. Unit: Participants

Measure	GSK1562902A 18-60 YOA Group n = 3342	GSK1562902A >60 YOA Group n = 403	Fluarix+Placebo 18-60 YOA Group n = 1123	Fluarix+Placebo >60 YOA Group n = 133
Any Arthralgia, Across	874	82	130	15
Grade 3 Arthralgia, Across	87	4	4	1
Related Arthralgia, Across	829	67	112	13
Any Fatigue, Across	1736	117	346	24
Grade 3 Fatigue, Across	155	4	8	3
Related Fatigue, Across	1576	100	289	17
Any Fever, Across	466	24	38	9
Grade 3 Fever, Across	16	1	0	0

Population analysed: The analysis was performed on the TVc which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms during the 7 days post-vaccination, Unsolicited AEs during the 21 post Dose 1 and 30 days post Dose 2; SAEs from Day 0 to Day 180.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK1562902A 18-60 YOA Group	27 of 3,397 (0.8%)	3,189 of 3,397 (93.9%)	Not reported
GSK1562902A >60 YOA Group	15 of 405 (3.7%)	338 of 405 (83.5%)	Not reported
Fluarix+Placebo 18-60 YOA Group	10 of 1,136 (0.9%)	938 of 1,136 (82.6%)	Not reported
Fluarix+Placebo >60 YOA Group	5 of 133 (3.8%)	83 of 133 (62.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 18407382Rumke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Drame M, Sanger R, Ballou WR. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine. 2008 May 2;26(19):2378-88. doi: 10.1016/j.vaccine.2008.02.068. Epub 2008 Mar 27.
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

40 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvanted pandemic influenza candidate vaccine and Fluarix in people with Influenza, run by GlaxoSmithKline at 40 sites in 7 countries.

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 5 inclusion and 13 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 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Germany, Spain, France, Russia, Estonia and 2 more countries. 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 3 Aug 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?

Number of Subjects With Solicited Local Symptoms (time frame: During a 7 day follow-up period after each dose of vaccine and overall.). The study lists 9 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 NCT00319098, which also lists 1 linked publication.

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 23 Jul 2018.