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InfluenzaPhase 1NCT01236040

Immunogenicity and Safety of Pandemic Influenza Vaccines in Adults Aged 18 - 49 Years Old

A Phase 1 study testing GSK Biologicals' investigational vaccine GSK2590066A, GSK Biologicals' investigational vaccine GSK2592984A and GSK Biologicals' investigational vaccine GSK2340274A in people with Influenza, run by GlaxoSmithKline at 4 sites in United States.

Completed

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

Official record
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Trial summary

This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
GSK Biologicals' investigational vaccine GSK2590066A, GSK Biologicals' investigational vaccine GSK2592984A and GSK Biologicals' investigational vaccine GSK2340274A
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
521 participants
Where
4 sitesUnited States
Study dates
29 Nov 2010to 20 Aug 2012
Phase
Phase 1
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Male and female adults, 18-49 years of age at the time of the first vaccination.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Safety laboratory test results within the parameters specified in the protocol.
  • Access to a consistent means of telephone contact
  • 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 urine pregnancy test on the day of first 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 H5N1 virus.
  • Increased risk of occupational exposure to H5N1 influenza viruses.
  • Previous vaccination at any time with an H5N1 vaccine, or with an oil-in water adjuvanted influenza vaccine.
  • Planned administration of an adjuvanted influenza vaccine or an H5N1 pandemic vaccine during the entire study period.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
Show all 20Show fewer
  • Presence 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.
  • Evidence of current substance abuse, including alcohol, by medical history.
  • Presence of a temperature >= 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first dose.
  • Diagnosed with cancer, or treatment for cancer, within 3 years. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
  • Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
  • Any 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 dosing, are eligible. Persons receiving prophylactic antiplatelet medications.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome.
  • Administration of an inactivated seasonal influenza vaccine within 14 days before the first study vaccine dose, or of any other vaccine(s) not foreseen by the study protocol within 30 days before the first study vaccine dose. The administration of live attenuated trivalent seasonal influenza virus vaccine (LAIV) is allowed.
  • Planned administration of any vaccine(s) not foreseen by the study protocol through completion of the Day 42 visit. The administration of LAIV is allowed.
  • Any known or suspected allergy to any constituent of influenza vaccines or to latex, or history of severe reaction to a previous influenza vaccination.
  • Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to the first study vaccine dose.
  • Lactating or nursing women.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Lenexa, Kansas, 66219

  • GSK Investigational Site

    Stockbridge, Georgia, 30281

Other trials in United States

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Cell Culture Derived Pandemic Influenza Vaccines GSK2590066A and GSK2592984A Administered to Healthy Adults 18 - 49 Years Old

This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.

Conditions
Influenza
Being tested
GSK Biologicals' investigational vaccine GSK2590066A, GSK Biologicals' investigational vaccine GSK2592984A, GSK Biologicals' investigational vaccine GSK2340274A, GSK Biologicals' investigational vaccine GSK2340273A, Placebo
Keywords
H5N1, Influenza, Pandemic
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 vaccine GSK2590066ABiological

    Intramuscular injection, two doses

  • GSK Biologicals' investigational vaccine GSK2592984ABiological

    Intramuscular injection, two doses

  • GSK Biologicals' investigational vaccine GSK2340274ABiological

    Intramuscular injection, two doses

  • GSK Biologicals' investigational vaccine GSK2340273ABiological

    Intramuscular injection, two doses

  • PlaceboOther

    Also called Control

    Intramuscular injection, two doses

Study groups in NCT01236040
Study groupRoleWhat they receive
Group AExperimentalSubjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval.
Receives: Biological: GSK Biologicals' investigational vaccine GSK2590066A
Group BExperimentalSubjects will receive 2 doses of a formulation of GSK2592984A vaccine at a 21-day interval.
Receives: Biological: GSK Biologicals' investigational vaccine GSK2592984A
Group CPlacebo comparatorSubjects will receive 2 doses of a placebo at a 21-day interval.
Receives: Other: Placebo
Group DExperimentalSubjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval.
Receives: Biological: GSK Biologicals' investigational vaccine GSK2590066A
Group EExperimentalSubjects will receive 2 doses of a formulation of GSK2340274A vaccine at a 21-day interval.
Receives: Biological: GSK Biologicals' investigational vaccine GSK2340274A
Group FExperimentalSubjects will receive 2 doses of a formulation of GSK2340273A vaccine at a 21-day interval.
Receives: Biological: GSK Biologicals' investigational vaccine GSK2340273A

What is being measured

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

  1. Immunogenicity with respect to components of the investigational vaccine Day 0

    Measured: Day 0

  2. Immunogenicity with respect to components of the investigational vaccine Day 42

    Measured: Day 42

  3. Occurrence of Grade 3 injection site pain

    Measured: During a 7-day follow-up period (Day 0 to 6) after any vaccination

Secondary outcomes (10)

  1. Occurrence of each solicited local symptom

    Measured: During a 7-day follow-up period (Day 0 to 6) after any vaccination

  2. Occurrence of each solicited general symptom

    Measured: During a 7-day follow-up period (Day 0 to 6) after any vaccination

  3. Occurrence of unsolicited adverse events (AEs)

    Measured: Within 21 days (Day 0 to 20) after any vaccination

  4. Occurrence of AEs with medically attended visits (MAEs)

    Measured: During the entire study period (from Day 0 to Month 12)

  5. Occurrence and relationship to vaccination of (potential) immune mediated diseases (pIMDs)

    Measured: During the entire study period (from Day 0 to Month 12)

  6. Occurrence and relationship to vaccination of serious adverse events (SAEs)

    Measured: During the entire study period (from Screening to Month 12)

  7. Occurrence of adverse pregnancy outcomes

    Measured: During the entire study period (from Day 0 to Month 12)

  8. Clinical safety laboratory abnormalities

    Measured: At Days 7, 28 and at Month 6.

  9. Immunogenicity with respect to components of the investigational vaccine in terms of hemagglutinin Inhibition (HI) antibodies

    Measured: At Days 0, 21, and 42 and Months 6 and 12

  10. Immunogenicity with respect to components of the investigational vaccine in terms of microneutralization (MN) antibodies

    Measured: Days 0, 21, and 42 and Months 6 and 12

Timeline

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

  1. First posted8 Nov 2010 (estimated)
  2. Study start29 Nov 2010
  3. Primary completion6 Sep 2011
  4. Study completion20 Aug 2012

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
521 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01236040
Sponsor's protocol ID
114371
Status last verified
May 2017
First submitted
28 Oct 2010
Last updated
10 May 2017
Results posted
No
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

  • Schuind A, Segall N, Drame M, Innis BL. Immunogenicity and Safety of an EB66 Cell-Culture-Derived Influenza A/Indonesia/5/2005(H5N1) AS03-Adjuvanted Vaccine: A Phase 1 Randomized Trial. J Infect Dis. 2015 Aug 15;212(4):531-41. doi: 10.1093/infdis/jiv091. Epub 2015 Feb 25.

    PubMed 25722291

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK Biologicals' investigational vaccine GSK2590066A, GSK Biologicals' investigational vaccine GSK2592984A and GSK Biologicals' investigational vaccine GSK2340274A in people with Influenza, run by GlaxoSmithKline at 4 sites in United States.

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 7 inclusion and 20 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Immunogenicity with respect to components of the investigational vaccine Day 0 (time frame: Day 0). The study lists 3 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 NCT01236040, 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 10 May 2017.

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