InfluenzaPhase 3NCT00616928

Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years

A Phase 3 study testing Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted in people with Influenza, run by GlaxoSmithKline at 40 sites in 2 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

The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity \& safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4,561 participants
Where: 40 sitesin 2 countries
Study dates: 23 Jan 2008to 19 Mar 2009
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

A male or female 18 years of age or greater at the time of the first vaccination.
Written informed consent obtained from the subject.
Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
Among subjects > 49 years of age, stable health status within 1 month prior to enrollment.
Access to a consistent means of telephone contact.
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Who cannot join

Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
Diagnosed with cancer, or treatment for cancer, within 3 years.
An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.

Show all 15Show fewer

Administration of any vaccines within 30 days before study enrollment.
Previous administration of any H5N1 vaccine.
Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to either vaccination.
Lactating or nursing.
Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.

Trial locations and contacts

40 sites in 2 countries.

Country

City, postcode or hospital

40 sites in 2 countries

United States30 sites

GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Chicago, Illinois, 60610
GSK Investigational Site
Cleveland, Ohio, 44122
GSK Investigational Site
Edison, New Jersey, 08817
GSK Investigational Site
Erie, Pennsylvania, 16506
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Huntsville, Alabama, 35802
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Melbourne, Florida, 32935
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Missoula, Montana, 59801
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Peoria, Illinois, 61602
GSK Investigational Site
Phoenix, Arizona, 85020
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Poughkeepsie, New York, 12601
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Rockville, Maryland, 20850
GSK Investigational Site
San Angelo, Texas, 76904
GSK Investigational Site
South Bend, Indiana, 46601
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
Wichita, Kansas, 67207

Other trials in United States

Canada10 sites

GSK Investigational Site
Greater Sudbury, Ontario, P3E 6C3
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
London, Ontario, N5W 6A2
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3
GSK Investigational Site
Québec, Quebec, G1E 7G9
GSK Investigational Site
Saint Romuald, Quebec, G6W 5M6
GSK Investigational Site
Sarnia, Ontario, N7T 4X3
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Woodstock, Ontario, N4S 4G3

Other trials in Canada

About this study

Official title: A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years

Conditions: Influenza
Being tested: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, Placebo
Keywords: vaccines, immunogenicity, human, safety, 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.

Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedBiological
Two intramuscular injections at Days 0 and 21.
PlaceboBiological
Two intramuscular injections at Days 0 and 21.

Study groups in NCT00616928
Study group	Role	What they receive
Influenza A (H5N1) 18-64Y Group	Experimental	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Placebo 18-64Y Group	Placebo comparator	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Placebo
Influenza A (H5N1) >64Y Group	Experimental	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Placebo >64Y Group	Placebo comparator	Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Placebo
Influenza A (H5N1) Group	Experimental	Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Placebo Group	Placebo comparator	Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Placebo
Influenza A (H5N1) 18-60Y Group	Experimental	Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Placebo 18-60Y Group	Placebo comparator	Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Placebo
Influenza A (H5N1) >60Y Group	Experimental	Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Placebo >60Y Group	Placebo comparator	Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm. Receives: Biological: Placebo

What is being measured

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

Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Measured: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Measured: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With Any Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Number of Subjects With Any Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Measured: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Number of Subjects With Any 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.
Measured: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
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: From Day 0 through Day 182 and through Day 379.
Number of Subjects With Medically Attended Events (MAEs)
Measured: From Day 0 through Day 182 and through Day 364.

Secondary outcomes (7)

Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Measured: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
Measured: At Month 6 (Day 182) post Dose 1
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Measured: At Month 6 (Day 182) after Dose 1
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Measured: At Month 6 (Day 182) after Dose 1
Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.
Measured: At Month 6 (Day 182) after Dose 1
Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.
Measured: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
Titers were expressed as Geometric Mean Titers (GMTs).
Measured: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

Timeline

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

23 Jan 200819 Mar 2009

First posted15 Feb 2008 (estimated)
Study start23 Jan 2008
Primary completion15 Oct 2008
Study completion19 Mar 2009

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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 4,561 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00616928
Sponsor's protocol ID: 110464
Status last verified: Oct 2016
First submitted: 28 Jan 2008
Last updated: 8 Jun 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

Langley JM, Risi G, Caldwell M, Gilderman L, Berwald B, Fogarty C, Poling T, Riff D, Baron M, Frenette L, Sheldon E, Collins H, Shepard M, Dionne M, Brune D, Ferguson L, Vaughn D, Li P, Fries L. Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study. J Infect Dis. 2011 Jun 15;203(12):1729-38. doi: 10.1093/infdis/jir172.
PubMed 21606531

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 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccination Regimen in Adults Aged ≥18 Years
ClinicalTrials.gov ID: NCT00616928
Acronym / sponsor ID: 110464
Conditions: Influenza
Keywords: vaccines, immunogenicity, human, safety, influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,561 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 23 Jan 2008
Primary completion: 15 Oct 2008 (actual)
Study completion: 19 Mar 2009 (actual)
First posted: 15 Feb 2008 (estimated)
Results: Posted 7 Feb 2014

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 10

Arm	Type	Receives
Influenza A (H5N1) 18-64Y Group	Experimental	Biological: Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedSubjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Placebo 18-64Y Group	Placebo comparator	Biological: PlaceboSubjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Influenza A (H5N1) >64Y Group	Experimental	Biological: Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedSubjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Placebo >64Y Group	Placebo comparator	Biological: PlaceboSubjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Influenza A (H5N1) Group	Experimental	Biological: Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedPooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Placebo Group	Placebo comparator	Biological: PlaceboPooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Influenza A (H5N1) 18-60Y Group	Experimental	Biological: Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedSubjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Placebo 18-60Y Group	Placebo comparator	Biological: PlaceboSubjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Influenza A (H5N1) >60Y Group	Experimental	Biological: Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedSubjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Placebo >60Y Group	Placebo comparator	Biological: PlaceboSubjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Who may qualify

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

Key inclusion criteria (6 listed)

A male or female 18 years of age or greater at the time of the first vaccination.
Written informed consent obtained from the subject.
Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
Among subjects > 49 years of age, stable health status within 1 month prior to enrollment.
Access to a consistent means of telephone contact.

Key exclusion criteria (15 listed)

Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
Diagnosed with cancer, or treatment for cancer, within 3 years.
An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.

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
Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedTwo intramuscular injections at Days 0 and 21.	Biological	Influenza A (H5N1) 18-60Y Group, Influenza A (H5N1) 18-64Y Group, Influenza A (H5N1) >60Y Group, Influenza A (H5N1) >64Y Group, Influenza A (H5N1) Group
PlaceboTwo intramuscular injections at Days 0 and 21.	Biological	Placebo 18-60Y Group, Placebo 18-64Y Group, Placebo >60Y Group, Placebo >64Y Group, Placebo Group

Primary outcome

Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Time frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Time frame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
Number of Subjects With Any Solicited Local Symptoms.
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Solicited General Symptoms.
Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time frame: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)
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.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 through Day 182 and through Day 379.
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.
Number of Subjects With Medically Attended Events (MAEs)
Time frame: From Day 0 through Day 182 and through Day 364.

7 secondary outcomes

Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10
Time frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10
Time frame: At Month 6 (Day 182) post Dose 1
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
Time frame: At Month 6 (Day 182) after Dose 1
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
Time frame: At Month 6 (Day 182) after Dose 1
Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)
Time frame: At Month 6 (Day 182) after Dose 1
Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.
Time frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays
Time frame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

Results and safety

Results posted to the registry on 7 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Influenza A (H5N1) 18-64Y Group	2,304	2,242
Placebo 18-64Y Group	768	750
Influenza A (H5N1) >64Y Group	1,118	1,101
Placebo >64Y Group	371	364

Primary outcome: Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)

Time frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2). Number. Unit: Subjects

Measure	Influenza A (H5N1) 18-64Y Group n = 1571	Placebo 18-64Y Group n = 76	Influenza A (H5N1) >64Y Group n = 396	Placebo >64Y Group n = 40
Value	1427	1	293	1

Population analysed: The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.

Primary outcome: Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)

Time frame: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2). Number. Unit: Subjects

Measure	Influenza A (H5N1) 18-64Y Group n = 1571	Placebo 18-64Y Group n = 76	Influenza A (H5N1) >64Y Group n = 396	Placebo >64Y Group n = 40
Day 0	5	0	9	0
Day 42	1467	1	334	1

Primary outcome: Number of Subjects With Any Solicited Local Symptoms.

Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration. Number. Unit: Subjects

Measure	Influenza A (H5N1) 18-64Y Group n = 2267	Placebo 18-64Y Group n = 754	Influenza A (H5N1) >64Y Group n = 1109	Placebo >64Y Group n = 368	Influenza A (H5N1) Group n = 3376	Placebo Group n = 1122
Pain	2024	171	784	53	2808	224
Redness	181	7	106	1	287	8
Swelling	241	7	110	1	351	8

Population analysed: The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.

Primary outcome: Number of Subjects With Any Solicited General Symptoms.

Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration. Number. Unit: Subjects

Measure	Influenza A (H5N1) 18-64Y Group n = 2266	Placebo 18-64Y Group n = 755	Influenza A (H5N1) >64Y Group n = 1109	Placebo >64Y Group n = 368	Influenza A (H5N1) Group n = 3375	Placebo Group n = 1123
Fatigue	890	189	258	64	1148	253
Headache	932	249	247	63	1179	312
Joint pain at other location	645	97	208	39	853	136
Muscle aches	1188	175	338	56	1526	231
Shivering	456	87	107	22	563	109
Sweating	314	67	48	15	362	109
Temperature	121	32	35	6	156	109

Population analysed: The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Influenza A (H5N1) 18-64Y Group	24 of 2,304 (1%)	2,087 of 2,304 (90.6%)	Not reported
Placebo 18-64Y Group	7 of 768 (0.9%)	405 of 768 (52.7%)	Not reported
Influenza A (H5N1) >64Y Group	43 of 1,118 (3.8%)	866 of 1,118 (77.5%)	Not reported
Placebo >64Y Group	14 of 371 (3.8%)	141 of 371 (38%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21606531Langley JM, Risi G, Caldwell M, Gilderman L, Berwald B, Fogarty C, Poling T, Riff D, Baron M, Frenette L, Sheldon E, Collins H, Shepard M, Dionne M, Brune D, Ferguson L, Vaughn D, Li P, Fries L. Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study. J Infect Dis. 2011 Jun 15;203(12):1729-38. doi: 10.1093/infdis/jir172.
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 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted in people with Influenza, run by GlaxoSmithKline at 40 sites in 2 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 6 inclusion and 15 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 8 Jun 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 United States, Canada. 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. Some participants in this study may receive a placebo. 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 7 Feb 2014). 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 Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1) (time frame: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)). The study lists 7 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 NCT00616928, 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 8 Jun 2018.