InfluenzaPhase 3NCT01626820

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults

A Phase 3 study testing Fluviral® in people with Influenza, run by GlaxoSmithKline at 1 site in Canada.

Completed

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

Trial summary

This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season. 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?: Fluviral®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 1 siteCanada
Study dates: 19 Jul 2012to 10 Aug 2012
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, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female 18 years of age and older 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.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:

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has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
Acute disease and/or fever at the time of enrolment.
Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness.

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Any confirmed or suspected immunosuppressive or immunodeficient condition.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Insulin-dependent diabetes mellitus.
Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
Any known or suspected allergy to any constituent of Fluviral® and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
A history of severe adverse reaction to a previous influenza vaccination.
Pregnant and/or lactating/nursing female.
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1

Other trials in Canada

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine (GSK1536489A) Fluviral® (2012/2013 Season) in Adults Aged 18 Years and Older

Conditions: Influenza
Being tested: Fluviral®
Keywords: Immunogenicity, Influenza, Safety, Adults, Fluviral
Medical subject headings: Influenza, Human

What participants receive

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

Fluviral®Biological
1 dose administered intramuscularly in deltoid region of non-dominant arm at Day 0

Study groups in NCT01626820
Study group	Role	What they receive
Fluviral Adults Group	Experimental	Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0. Receives: Biological: Fluviral®
Fluviral Elderly Group	Experimental	Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0. Receives: Biological: Fluviral®

What is being measured

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

Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
Measured: At Day 0 and Day 21
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
Measured: At Day 0 and Day 21
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
Measured: At Day 21
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.
MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).
Measured: At Day 21

Secondary outcomes (4)

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling were defined as ecchymosis, induration, redness and swelling above 100 millimeters (mm).
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever [oral temperature ≥38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination, Any fever = oral temperature ≥38.0 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Measured: During the 21-day (Days 0-20) post-vaccination period.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: During the entire study period (Day 0 - Day 20 after vaccination).

Timeline

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

19 Jul 201210 Aug 2012

First posted25 Jun 2012 (estimated)
Study start19 Jul 2012
Primary completion10 Aug 2012
Study completion10 Aug 2012

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01626820
Sponsor's protocol ID: 116664
Status last verified: Aug 2016
First submitted: 21 Jun 2012
Last updated: 7 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?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of GSK Biologicals' Trivalent Split Virion Influenza Vaccine (GSK1536489A) Fluviral® (2012/2013 Season) in Adults Aged 18 Years and Older
ClinicalTrials.gov ID: NCT01626820
Acronym / sponsor ID: 116664
Conditions: Influenza
Keywords: Immunogenicity, Influenza, Safety, Adults, Fluviral
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 19 Jul 2012
Primary completion: 10 Aug 2012 (actual)
Study completion: 10 Aug 2012 (actual)
First posted: 25 Jun 2012 (estimated)
Results: Posted 14 Oct 2013

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fluviral Adults Group	Experimental	Biological: Fluviral®Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Fluviral Elderly Group	Experimental	Biological: Fluviral®Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.

Who may qualify

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

Key inclusion criteria (9 listed)

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female 18 years of age and older 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.
Female subjects of non-childbearing potential may be enrolled in the study.

Key exclusion criteria (19 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
Acute disease and/or fever at the time of enrolment.

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
Fluviral®1 dose administered intramuscularly in deltoid region of non-dominant arm at Day 0	Biological	Fluviral Adults Group, Fluviral Elderly Group

Primary outcome

Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Time frame: At Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 0 and Day 21
A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.
Time frame: At Day 21
MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).

4 secondary outcomes

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Time frame: During the 21-day (Days 0-20) post-vaccination period.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 0 - Day 20 after vaccination).

Results and safety

Results posted to the registry on 14 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluviral Adults Group	56	56
Fluviral Elderly Group	57	57

Primary outcome: Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.

Time frame: At Day 0 and Day 21. Mean (95% Confidence Interval). Unit: Titer

Measure	Fluviral Adults Group n = 56	Fluviral Elderly Group n = 56
[H1N1 strain, Day 0]	84.03 (56.69 to 124.57)	40.48 (27.97 to 58.58)
[H1N1 strain, Day 21]	306.51 (237.33 to 395.86)	159.02 (116.82 to 216.46)
[H3N2 strain, Day 0]	24.82 (17.10 to 36.04)	37.33 (25.78 to 54.06)
[H3N2 strain, Day 21]	151.32 (109.35 to 209.39)	167.04 (117.38 to 237.71)
[Yamagata strain, Day 0]	82.50 (60.43 to 112.63)	65.58 (52.23 to 82.35)
[Yamagata strain, Day 21]	328.03 (253.70 to 424.14)	234.79 (187.46 to 294.06)

Population analysed: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Primary outcome: Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

Time frame: At Day 0 and Day 21. Number. Unit: Subjects

Measure	Fluviral Adults Group n = 56	Fluviral Elderly Group n = 56
[H1N1 strain, Day 0]	43	31
[H1N1 strain, Day 21]	56	53
[H3N2 strain, Day 0]	25	32
[H3N2 strain, Day 21]	51	51
[Yamagata strain, Day 0]	47	46
[Yamagata strain, Day 21]	56	56

Primary outcome: Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.

Time frame: At Day 21. Number. Unit: Subjects

Measure	Fluviral Adults Group n = 56	Fluviral Elderly Group n = 56
[H1N1 strain]	22	22
[H3N2 strain]	27	23
[Yamagata strain]	26	27

Primary outcome: Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.

Time frame: At Day 21. Mean (95% Confidence Interval). Unit: Fold increase

Measure	Fluviral Adults Group n = 56	Fluviral Elderly Group n = 56
[H1N1 strain]	3.6 (2.5 to 5.4)	3.9 (2.7 to 5.7)
[H3N2 strain]	6.1 (4.0 to 9.4)	4.5 (3.0 to 6.8)
[Yamagata strain]	4.0 (2.9 to 5.5)	3.6 (2.7 to 4.7)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events:During the entire study period i.e. Days 0-20 after vaccination; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluviral Adults Group	0 of 56 (0%)	43 of 56 (76.8%)	Not reported
Fluviral Elderly Group	0 of 57 (0%)	18 of 57 (31.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluviral® in people with Influenza, run by GlaxoSmithKline at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 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 7 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 1 site in 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. 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 14 Oct 2013). 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 Each of the Vaccine Influenza Virus Strains. (time frame: At Day 0 and Day 21). The study lists 4 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 NCT01626820.

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 7 Sep 2018.