- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00989287
Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults
June 11, 2019 updated by: GlaxoSmithKline
Safety and Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2340272A in Adults Aged 18 to 60 Years
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in adults aged 18 to 60 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This Protocol Posting has been updated following Protocol amendment 1, October 2009.
The impacted section is the outcomes measures section.
Study Type
Interventional
Enrollment (Actual)
131
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gent, Belgium, 9000
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A male or female aged 18 to 60 years at the time of the first vaccination.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Satisfactory baseline medical assessment by history and physical examination. Stable health status is defined as the absence of health event satisfying the definition of an SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device.
- 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 two months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of an axillary temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within the past three years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Chronic administration of immunosuppressants or other immune modifying drugs within six months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for persons for > two weeks. Inhaled and topical steroids are allowed.
- Receipt of any immunoglobulins and/or any blood products within three months of study enrolment or planned administration of any of these products during the study period.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- Administration of any vaccines within 30 days before vaccination.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: GSK2340272A Group
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
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Two intramuscular injections in the deltoid region of the non-dominant arm.
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EXPERIMENTAL: GSK2340269A Group
Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
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Two intramuscular injections in the deltoid region of the non-dominant arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Day 21
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Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
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At Day 21
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Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Day 21
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A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
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At Day 21
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Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Day 21
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GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.
The flu strain assessed was Flu A/CAL/7/09.
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At Day 21
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: During the entire study period (from Day 0 up to Day 364)
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SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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During the entire study period (from Day 0 up to Day 364)
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Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Days 0, 21 and 42
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A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.
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At Days 0, 21 and 42
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Days 0, 21 and 42
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Titers are presented as geometric mean titers (GMTs).
The flu strain assessed was Flu A/CAL/7/09.
The reference seropositivity cut-off value was ≥ 1:10.
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At Days 0, 21 and 42
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Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Days 0, 21 and 42
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A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.
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At Days 0, 21 and 42
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Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Days 0, 21 and 42
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Titers are presented as geometric mean titers (GMTs).
The flu strain assessed was Flu A/CAL/7/09.
The reference seropositivity cut-off value was ≥ 1:10.
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At Days 0, 21 and 42
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Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Days 182 and 364
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A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.
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At Days 182 and 364
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Titers for Serum HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Days 182 and 364
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Titers are presented as geometric mean titers (GMTs).
The flu strain assessed was Flu A/CAL/7/09.
The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.
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At Days 182 and 364
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Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Days 182 and 364
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A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.
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At Days 182 and 364
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Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Days 182 and 364
|
Titers are presented as geometric mean titers (GMTs).
The flu strain assessed was Flu A/CAL/7/09.
The reference seropositivity cut-off value was ≥ 1:10.
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At Days 182 and 364
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Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Days 21 and 42
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Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
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At Days 21 and 42
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Number of Seroconverted (SCR) Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Days 182 and 364
|
Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
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At Days 182 and 364
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Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Days 182 and 364
|
Seroconversion was defined as: For initially seronegative subjects (antibody titer < 10 post-vaccination), antibody titer ≥ 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer.
The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).
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At Days 182 and 364
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Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Days 0, 21 and 42
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A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.
|
At Days 0, 21 and 42
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Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time Frame: At Days 182 and 364
|
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection.
|
At Days 182 and 364
|
Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Days 21 and 42
|
GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.
The flu strain assessed was Flu A/CAL/7/09.
|
At Days 21 and 42
|
Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease
Time Frame: At Days 182 and 364
|
GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination.
The flu strain assessed was Flu A/CAL/7/09.
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At Days 182 and 364
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time Frame: During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school.
Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
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During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)
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Number of Days With Solicited Local Symptoms
Time Frame: During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)
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The number of days with any solicited local symptoms reported during the solicited post-vaccination period.
No subjects in GSK2340269A Group reported redness or swelling.
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During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time Frame: During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)
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Assessed solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)].
Any = occurrence of the symptom regardless of intensity grade or their relationship to vaccination.
Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider.
Grade 3 fever = temperature ≥ 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)
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Number of Days With Solicited General Symptoms
Time Frame: During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)
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The number of days with any solicited general symptoms reported during the solicited post-vaccination period.
No subjects from the GSK2340269A Group reported any temperature after Dose 2.
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During the 7-day post-vaccination period following Dose 1 (Day 0-6), Dose 2 (Day 21-27), and across doses (Day 0-6 and 21-27)
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Number of Subjects With Adverse Events of Specific Interest (AESIs)
Time Frame: From Day 0 up to Day 364
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An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
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From Day 0 up to Day 364
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time Frame: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)
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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.
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Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Roman F, Clement F, Dewe W, Walravens K, Maes C, Willekens J, De Boever F, Hanon E, Leroux-Roels G. Effect on cellular and humoral immune responses of the AS03 adjuvant system in an A/H1N1/2009 influenza virus vaccine administered to adults during two randomized controlled trials. Clin Vaccine Immunol. 2011 May;18(5):835-43. doi: 10.1128/CVI.00480-10. Epub 2011 Mar 30.
- van der Most RG, Clement F, Willekens J, Dewe W, Walravens K, Vaughn DW, Leroux-Roels G. Long-Term Persistence of Cell-Mediated and Humoral Responses to A(H1N1)pdm09 Influenza Virus Vaccines and the Role of the AS03 Adjuvant System in Adults during Two Randomized Controlled Trials. Clin Vaccine Immunol. 2017 Jun 5;24(6):e00553-16. doi: 10.1128/CVI.00553-16. Print 2017 Jun.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 7, 2009
Primary Completion (ACTUAL)
October 9, 2009
Study Completion (ACTUAL)
October 26, 2010
Study Registration Dates
First Submitted
October 1, 2009
First Submitted That Met QC Criteria
October 1, 2009
First Posted (ESTIMATE)
October 5, 2009
Study Record Updates
Last Update Posted (ACTUAL)
June 26, 2019
Last Update Submitted That Met QC Criteria
June 11, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113866
- 2009-016078-33 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Study Data/Documents
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Informed Consent Form
Information identifier: 113866Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 113866Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 113866Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 113866Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 113866Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 113866Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 113866Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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