InfluenzaPhase 3NCT00812981
A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.
A Phase 3 study testing GSK1562902A in people with Influenza, run by GlaxoSmithKline at 1 site in Taiwan.
Trial summary
This observer-blind study is designed to show the immunological non-inferiority of Thiomersal-free-processed pandemic influenza vaccine as compared to the Thiomersal-containing-processed pandemic influenza vaccine. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK1562902A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Nov 2008to 7 Jun 2009
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 18 to 60 years at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Good general health as established by medical history and clinical examination before entering into the study.
- 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
- Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Who cannot join
- Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- An oral temperature ≥ 37.8 º C or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Receipt of systemic glucocorticoids (prednisone ≥ 5 mg/kg/day for more than 14 consecutive days) within 1 month of study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment.
- Any significant disorder of coagulation or treatment with Coumarin derivatives or Heparin.
Show all 16Show fewer
- Administration of any vaccines within 30 days before study enrolment.
- Previous administration of any H5N1 vaccine.
- Previous administration of vaccines with adjuvants similar to those used in the investigational vaccine.
- Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrolment, or during the 180 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
- 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 known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); 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 (β-hCG) test result prior to either vaccination.
- Lactating women.
- Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-inferiority Study of GSK Biologicals' Pandemic Influenza Vaccine 1562902A.
This observer-blind study is designed to show the immunological non-inferiority of Thiomersal-free-processed pandemic influenza vaccine as compared to the Thiomersal-containing-processed pandemic influenza vaccine.
- Conditions
- Influenza
- Being tested
- GSK1562902A
- Keywords
- Pandemic 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.
GSK1562902ABiological
new-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm
GSK1562902ABiological
comparative-processed (CP), administered intramuscularly in the deltoid region of the non-dominant arm
| Study group | Role | What they receive |
|---|---|---|
| 1562902A NP GROUP | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21. Receives: Biological: GSK1562902A |
| 1562902A CP GROUP | Experimental | Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21. Receives: Biological: GSK1562902A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Measured: At Day 42
Secondary outcomes (16)
Titers for Serum H5N1 HI Antibodies
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Measured: At Day 0 and Day 180
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value
The cut-off values for the humoral immune response in terms of H5N1 HI antibodies were equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Measured: At Days 0, 42 and 180
Number of Seroconverted Subjects Against Two Strains of Influenza Disease
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer below (<) 1:10 and a post-vaccination titer equal to or above (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Measured: At Day 42 and Day 180
Seroconversion Factor (SCF) for H5N1 HI Antibodies
The seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Measured: At Day 42 and Day 180
Number of Seroprotected Subjects for H5N1 HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Measured: At Days 0, 42 and 180
Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Vietnam/1194/2004.
Measured: At Days 0, 42 and 180
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.
Measured: At Days 0, 42 and 180
Number of Seroconverted Subjects for Neutralizing Antibodies
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:28 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer. The flu strain assessed was A/Vietnam/1194/2004.
Measured: At Day 42 and Day 180
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Adverse Events of Specific Interest (AESIs)
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.
Measured: From Day 0 up to 51 days after the first vaccination
Number of Subjects With Any AESIs
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.
Measured: During the entire study period (from Day 0 up to Day 180)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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.
Measured: During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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.
Measured: During the entire study period (from Day 0 up to Day 180)
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Day 0 up to Day 51
Number of Subjects With SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Day 0 up to Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study start15 Nov 2008
- Primary completion7 Jun 2009
- Study completion7 Jun 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 320 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
- NCT00812981
- Sponsor's protocol ID
- 111954
- Status last verified
- Mar 2017
- First submitted
- 18 Dec 2008
- Last updated
- 20 Aug 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
Yang PC, Yu CJ, Chang SC, Hsieh SM, Drame M, Walravens K, Roman F, Gillard P. Safety and immunogenicity of a split-virion AS03A-adjuvanted A/Indonesia/05/2005 (H5N1) vaccine in Taiwanese adults. J Formos Med Assoc. 2012 Jun;111(6):333-9. doi: 10.1016/j.jfma.2011.02.006. Epub 2012 Apr 20.
PubMed 22748624
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of GSK Biologicals' Pandemic Influenza Vaccine 1562902A.
- ClinicalTrials.gov ID
- NCT00812981
- Acronym / sponsor ID
- 111954
- Conditions
- Influenza
- Keywords
- Pandemic influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2008 (actual)
- Primary completion
- 7 Jun 2009 (actual)
- Study completion
- 7 Jun 2009 (actual)
- First posted
- 22 Dec 2008 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observer-blind study is designed to show the immunological non-inferiority of Thiomersal-free-processed pandemic influenza vaccine as compared to the Thiomersal-containing-processed pandemic influenza vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1562902A NP GROUP | Experimental | Biological: GSK1562902AHealthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21. |
| 1562902A CP GROUP | Experimental | Biological: GSK1562902AHealthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 18 to 60 years at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Good general health as established by medical history and clinical examination before entering into the study.
- 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
Key exclusion criteria (16 listed)
- Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- An oral temperature ≥ 37.8 º C or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Receipt of systemic glucocorticoids (prednisone ≥ 5 mg/kg/day for more than 14 consecutive days) within 1 month of study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study 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 |
|---|---|---|
| GSK1562902Anew-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm | Biological | 1562902A NP GROUP |
| GSK1562902Acomparative-processed (CP), administered intramuscularly in the deltoid region of the non-dominant arm | Biological | 1562902A CP GROUP |
Primary outcome
Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies
Time frame: At Day 42
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
16 secondary outcomes
Titers for Serum H5N1 HI Antibodies
Time frame: At Day 0 and Day 180
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value
Time frame: At Days 0, 42 and 180
Number of Seroconverted Subjects Against Two Strains of Influenza Disease
Time frame: At Day 42 and Day 180
Seroconversion Factor (SCF) for H5N1 HI Antibodies
Time frame: At Day 42 and Day 180
Number of Seroprotected Subjects for H5N1 HI Antibodies
Time frame: At Days 0, 42 and 180
Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease
Time frame: At Days 0, 42 and 180
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Time frame: At Days 0, 42 and 180
Number of Seroconverted Subjects for Neutralizing Antibodies
Time frame: At Day 42 and Day 180
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Adverse Events of Specific Interest (AESIs)
Time frame: From Day 0 up to 51 days after the first vaccination
Number of Subjects With Any AESIs
Time frame: During the entire study period (from Day 0 up to Day 180)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During the entire study period (from Day 0 up to Day 180)
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0 up to Day 51
Number of Subjects With SAEs
Time frame: During the entire study period (from Day 0 up to Day 180)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22748624Yang PC, Yu CJ, Chang SC, Hsieh SM, Drame M, Walravens K, Roman F, Gillard P. Safety and immunogenicity of a split-virion AS03A-adjuvanted A/Indonesia/05/2005 (H5N1) vaccine in Taiwanese adults. J Formos Med Assoc. 2012 Jun;111(6):333-9. doi: 10.1016/j.jfma.2011.02.006. Epub 2012 Apr 20.
- 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 GSK1562902A in people with Influenza, run by GlaxoSmithKline at 1 site in Taiwan.
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 16 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 20 Aug 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 Taiwan. 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 16 Jun 2017). 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?
Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies (time frame: At Day 42). 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 NCT00812981, 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 20 Aug 2018.