InfluenzaPhase 2NCT01008956
Safety and Immune Response of One-Dose of Candidate H1N1 Influenza Vaccine GSK2340274A in Adults
A Phase 2 study testing GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A in people with Influenza, run by GlaxoSmithKline.
Trial summary
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Indian male or female adults 18 to 64 years of age at time of the first vaccination, inclusive.
- Written informed consent obtained from the subject
- Good general health as assessed by medical history and physical examination.
- 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 other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments)
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Female subjects of non-childbearing potential may be enrolled in the study.
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- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- 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 series.
Who cannot join
- Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
- Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
- Presence or 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 a temperature >= 38.0ºC (>=100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness ("uncontrolled" is defined as requiring institution of new medical or surgical treatment or a significant alteration in the dose of an ongoing medication for uncontrolled symptoms, illness manifestations or drug toxicity within 3 months preceding the receipt of study vaccine).
- Diagnosed with cancer, or treatment for cancer within 3 years.
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- Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
- Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are accepted and may enrol, but other histologic types of skin cancer are exclusionary.
- Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enrol.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 10 mg/day of prednisone or equivalent when administered for > 2 weeks. Topical, intra-articular or inhaled and topical steroids are allowed.
- Receipt of any immunoglobulins and/or any blood products within 3 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, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- With the exception of seasonal influenza vaccination, administration of any vaccines within 30 days before vaccination. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination.
- Planned administration of any vaccine not foreseen by the study protocol from vaccination up to blood sampling at Day 21 including seasonal influenza vaccine or a monovalent pandemic H1N1 vaccine other than the study vaccine.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the receipt of study vaccine, or planned use during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine; 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 (ß-hCG) test result prior to the time of vaccination.
- Lactating or nursing female.
- Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine GSK2340274A in Adults 18 to 64 Years of Age
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.
- Conditions
- Influenza
- Being tested
- GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A
- Keywords
- Influenza, H1N1, Pandemic, GSK Bio's influenza vaccine GSK2340274A
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274ABiological
Intramuscular injection, one dose
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Subjects enrolled in this group will be stratified by age (18 to 40 years and 41 to 64 years) Receives: Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A |
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 (Vaccine virus-homologous responses)
Measured: At Day 21 after vaccination
Secondary outcomes (5)
Humoral immune response in terms of HI antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains
Measured: At Day 0, 21 and 182 after vaccination
Humoral immune response in terms of neutralizing antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains
Measured: At Day 0, 21 and 182 after vaccination
Occurrence of solicited local and general symptoms
Measured: During a 7-day (Day 0-6) follow-up period after vaccination.
Occurrence of unsolicited adverse events
Measured: During a 21-day (Day 0-20) follow-up period after vaccination and from Days 0 to 84.
Occurrence of medically attended and/or serious adverse events, and of potentially immune-mediated diseases.
Measured: From the beginning up to the end of the study (Day 182)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startApr 2010
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Why it stopped: Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008956
- Sponsor's protocol ID
- 113924
- Status last verified
- Mar 2015
- First submitted
- 5 Nov 2009
- Last updated
- 23 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine GSK2340274A in Adults 18 to 64 Years of Age
- ClinicalTrials.gov ID
- NCT01008956
- Acronym / sponsor ID
- 113924
- Conditions
- Influenza
- Keywords
- Influenza, H1N1, Pandemic, GSK Bio's influenza vaccine GSK2340274A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Biological: GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274ASubjects enrolled in this group will be stratified by age (18 to 40 years and 41 to 64 years) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Indian male or female adults 18 to 64 years of age at time of the first vaccination, inclusive.
- Written informed consent obtained from the subject
- Good general health as assessed by medical history and physical examination.
- 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 other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments)
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
Key exclusion criteria (21 listed)
- Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
- Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
- Presence or 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 a temperature >= 38.0ºC (>=100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness ("uncontrolled" is defined as requiring institution of new medical or surgical treatment or a significant alteration in the dose of an ongoing medication for uncontrolled symptoms, illness manifestations or drug toxicity within 3 months preceding the receipt of study vaccine).
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 |
|---|---|---|
| GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274AIntramuscular injection, one dose | Biological | Single Group |
Primary outcome
Humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (Vaccine virus-homologous responses)
Time frame: At Day 21 after vaccination
5 secondary outcomes
Humoral immune response in terms of HI antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains
Time frame: At Day 0, 21 and 182 after vaccination
Humoral immune response in terms of neutralizing antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains
Time frame: At Day 0, 21 and 182 after vaccination
Occurrence of solicited local and general symptoms
Time frame: During a 7-day (Day 0-6) follow-up period after vaccination.
Occurrence of unsolicited adverse events
Time frame: During a 21-day (Day 0-20) follow-up period after vaccination and from Days 0 to 84.
Occurrence of medically attended and/or serious adverse events, and of potentially immune-mediated diseases.
Time frame: From the beginning up to the end of the study (Day 182)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A in people with Influenza, run by GlaxoSmithKline.
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 11 inclusion and 21 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: withdrawn, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 (Vaccine virus-homologous responses) (time frame: At Day 21 after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.