InfluenzaPhase 3NCT01440387

A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older

A Phase 3 study testing FLULAVAL® QUADRIVALENT 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

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline (GSK) Biologicals' investigational quadrivalent split virion influenza vaccine FLU-Q-QIV in adults 18 years of age and older. 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?: FLULAVAL® QUADRIVALENT
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 1 siteCanada
Study dates: 30 Sep 2011to 22 Oct 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 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.
Written informed consent obtained from the subject
Male and female adults, 18 years of age and older in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
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:
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

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.
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.
Acute disease and/or fever at the time of enrolment.
Significant acute or chronic, uncontrolled medical or psychiatric illness.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Show all 19Show fewer

Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
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 study vaccine dose.
A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
Presence of an active neurological disorder.
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 anti-platelet 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 FLU-Q-QIV 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: A Phase IIIA Study of Immunogenicity and Safety of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older

Conditions: Influenza
Being tested: FLULAVAL® QUADRIVALENT
Keywords: Influenza, Phase III, Seasonal 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.

FLULAVAL® QUADRIVALENTBiological
Intramuscular injection, 1 dose each in FLULAVAL QUADRIVALENT Adults and FLULAVAL QUADRIVALENT Elderly Groups

Study groups in NCT01440387
Study group	Role	What they receive
FLULAVAL QUADRIVALENT Adult Group	Experimental	Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. Receives: Biological: FLULAVAL® QUADRIVALENT
FLULAVAL QUADRIVALENT Elderly Group	Experimental	Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. Receives: Biological: FLULAVAL® QUADRIVALENT

What is being measured

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

Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.
Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.
Measured: At Day 0 and Day 21
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
Measured: At Day 0 and Day 21
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 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 strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
Measured: At Day 21
HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains.
SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
Measured: At Day 21

Secondary outcomes (4)

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling greater than 100 millimeters (mm). i.e. >100mm.
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 chest tightness, chills, cough, fatigue, headache, joint pain at other location, muscle pain, red eyes, sore throat, swelling of the face and fever [oral temperature ≥ 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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)
A serious adverse event was any untoward medical occurrence 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.

30 Sep 201122 Oct 2011

First posted26 Sep 2011 (estimated)
Study start30 Sep 2011
Primary completion22 Oct 2011
Study completion22 Oct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01440387
Sponsor's protocol ID: 115418
Status last verified: Aug 2016
First submitted: 8 Sep 2011
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.

Publications

Jain VK, Chandrasekaran V, Wang L, Li P, Liu A, Innis BL. A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine. BMC Infect Dis. 2014 Mar 10;14:133. doi: 10.1186/1471-2334-14-133.
PubMed 24606983

Want to know more?

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

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

Questions to ask the study team

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

See locations

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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: A Phase IIIA Study of Immunogenicity and Safety of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
ClinicalTrials.gov ID: NCT01440387
Acronym / sponsor ID: 115418
Conditions: Influenza
Keywords: Influenza, Phase III, Seasonal influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Sep 2011
Primary completion: 22 Oct 2011 (actual)
Study completion: 22 Oct 2011 (actual)
First posted: 26 Sep 2011 (estimated)
Results: Posted 19 Nov 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: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
FLULAVAL QUADRIVALENT Adult Group	Experimental	Biological: FLULAVAL® QUADRIVALENTSubjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
FLULAVAL QUADRIVALENT Elderly Group	Experimental	Biological: FLULAVAL® QUADRIVALENTSubjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

Who may qualify

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

Key inclusion criteria (8 listed)

Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject
Male and female adults, 18 years of age and older in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
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:

Key exclusion criteria (19 listed)

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.
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.
Acute disease and/or fever at the time of enrolment.
Significant acute or chronic, uncontrolled medical or psychiatric illness.

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
FLULAVAL® QUADRIVALENTIntramuscular injection, 1 dose each in FLULAVAL QUADRIVALENT Adults and FLULAVAL QUADRIVALENT Elderly Groups	Biological	FLULAVAL QUADRIVALENT Adult Group, FLULAVAL QUADRIVALENT Elderly Group

Primary outcome

Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.
Time frame: At Day 0 and Day 21
Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Time frame: At Day 0 and Day 21
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 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 strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains.
Time frame: At Day 21
SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.

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 19 Nov 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
FLULAVAL QUADRIVALENT Adult Group	56	56
FLULAVAL QUADRIVALENT Elderly Group	56	56

Primary outcome: Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.

Time frame: At Day 0 and Day 21. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	FLULAVAL QUADRIVALENT Adult Group n = 56	FLULAVAL QUADRIVALENT Elderly Group n = 56
Yamagata strain, Day 0	130.4 (92.8 to 183.2)	57.3 (44.3 to 74.0)
Yamagata strain, Day 21	404.8 (323.1 to 507.2)	355.5 (263.5 to 479.5)
Victoria strain, Day 0	92.8 (66.5 to 129.4)	38.5 (28.3 to 52.4)
Victoria strain, Day 21	318.0 (251.4 to 402.3)	237.8 (179.7 to 314.9)
H1N1 strain, Day 0	82.0 (54.9 to 122.5)	25.0 (17.3 to 36.0)
H1N1 strain, Day 21	392.5 (305.4 to 504.4)	223.5 (157.0 to 318.1)
H3N2 strain, Day 0	45.3 (31.3 to 65.4)	23.2 (16.4 to 32.8)
H3N2 strain, Day 21	215.4 (166.3 to 278.9)	160.1 (115.7 to 221.4)

Population analysed: The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Primary outcome: Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.

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

Measure	FLULAVAL QUADRIVALENT Adult Group n = 56	FLULAVAL QUADRIVALENT Elderly Group n = 56
Yamagata strain, Day 0	48	45
Yamagata strain, Day 21	56	56
Victoria strain, Day 0	47	31
Victoria strain, Day 21	56	55
H1N1 strain, Day 0	44	26
H1N1 strain, Day 21	55	52
H3N2 strain, Day 0	34	28
H3N2 strain, Day 21	54	53

Primary outcome: Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.

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

Measure	FLULAVAL QUADRIVALENT Adult Group n = 56	FLULAVAL QUADRIVALENT Elderly Group n = 56
Yamagata strain	20	35
Victoria strain	19	33
H1N1 strain	28	34
H3N2 strain	27	35

Primary outcome: HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains.

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

Measure	FLULAVAL QUADRIVALENT Adult Group n = 56	FLULAVAL QUADRIVALENT Elderly Group n = 56
Yamagata strain	3.1 (2.4 to 4.0)	6.2 (4.6 to 8.4)
Victoria strain	3.4 (2.5 to 4.6)	6.2 (4.3 to 8.8)
H1N1 strain	4.8 (3.3 to 7.0)	8.9 (5.8 to 13.7)
H3N2 strain	4.8 (3.5 to 6.6)	6.9 (4.7 to 10.1)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events: During the entire study period (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
FLULAVAL QUADRIVALENT Adult Group	0 of 56 (0%)	46 of 56 (82.1%)	Not reported
FLULAVAL QUADRIVALENT Elderly Group	0 of 56 (0%)	28 of 56 (50%)	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.
Derived from this study: PubMed 24606983Jain VK, Chandrasekaran V, Wang L, Li P, Liu A, Innis BL. A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine. BMC Infect Dis. 2014 Mar 10;14:133. doi: 10.1186/1471-2334-14-133.
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 FLULAVAL® QUADRIVALENT 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 8 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 19 Nov 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?

Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza 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 NCT01440387, 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 7 Sep 2018.