InfluenzaPhase 2NCT01035749
Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years
A Phase 2 study testing GSK Biologicals' Influenza investigational vaccine GSK2340274A and GSK Biologicals' Influenza investigational vaccine GSK2340273A in people with Influenza, run by GlaxoSmithKline at 9 sites in 2 countries.
Trial summary
The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK Biologicals' Influenza investigational vaccine GSK2340274A and GSK Biologicals' Influenza investigational vaccine GSK2340273A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Feb 2010to 10 May 2011
- Phase
- Phase 2
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female children 10 to < 18 years of age at the time of the first vaccination. "Less than 18 years of age" implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol.
- Written informed consent obtained from the subject's parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
- Good general health as established by medical history and clinical examination before entering into the study.
- Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
- Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol.
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 of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
- Presence of a temperature >= 38.0ºC 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.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Show all 16Show fewer
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
- Receipt of any immunoglobulins and/or any blood products within 6 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 are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, 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.
- Administration of any licensed vaccine within 30 days before the first dose of study vaccine, with the exception of seasonal influenza vaccine (which may be given within 2 weeks before the first dose of study vaccine).
- Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 189 phlebotomy.
- Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 42 after the first vaccine dose, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
- Child in care.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Slovakia8 sites
GSK Investigational Site
Cífer, 919 43
GSK Investigational Site
Dolný Kubín, 026 01
GSK Investigational Site
Dunajská Streda, 929 01
GSK Investigational Site
Nová Dubnica, 018 51
GSK Investigational Site
Nové Mesto nad Váhom, 915 01
GSK Investigational Site
Púchov, 020 01
GSK Investigational Site
Ružomberok, 034 01
GSK Investigational Site
Trenčín, 911 01
About this study
Official title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Children Aged 10 to Less Than 18 Years
The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.
- Conditions
- Influenza
- Being tested
- GSK Biologicals' Influenza investigational vaccine GSK2340274A, GSK Biologicals' Influenza investigational vaccine GSK2340273A, Placebo (saline)
- Keywords
- pandemic influenza, Clinical trial, H1N1, children
- 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' Influenza investigational vaccine GSK2340274ABiological
One or two doses administered intramuscularly
GSK Biologicals' Influenza investigational vaccine GSK2340273ABiological
Two doses intramuscularly
Placebo (saline)Biological
One dose intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| AREPANRIX-ADJUVANTED F1 2D GROUP | Experimental | Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. Receives: Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A; Biological: Placebo (saline) |
| AREPANRIX-ADJUVANTED F2 2D GROUP | Experimental | Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. Receives: Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A; Biological: Placebo (saline) |
| AREPANRIX-ADJUVANTED F2 3D GROUP | Experimental | Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). Receives: Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A |
| AREPANRIX-UNADJUVANTED F2 2D GROUP | Experimental | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. Receives: Biological: GSK Biologicals' Influenza investigational vaccine GSK2340273A; Biological: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre
Measured: At Day 21
Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
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.
Measured: At Day 0 and Day 21
HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
Measured: At Day 21
Secondary outcomes (25)
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Antibody titres were expressed as Geometric mean titers (GMTs).
Measured: At Day 0 and Day 42
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Antibody titres were expressed as GMTs.
Measured: At Day 0 and Day 182
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Antibody titres were expressed as Geometric mean titers (GMTs).
Measured: At Days 0, 182 and 189
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.
Measured: At Day 42
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Antibody titers were expressed as GMTs.
Measured: At Day 0 and Day 21
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.
Measured: At Day 182
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity.
Measured: At Day 189
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity.
Measured: At Day 189
The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.
Measured: At Day 0 and Day 42
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.
Measured: At Day 0 and Day 182
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
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.
Measured: At Day 0, Day 182 and Day 189
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 42
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 182
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 189
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Measured: At Day 189
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose
Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity
Measured: During the 7-day (Days 0-6) post-vaccination period following booster dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 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 = axillary temperature equal to or above (≥) 39.0°C.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 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 = axillary temperature equal to or above (≥) 39.0°C.
Measured: During the 7-day (Days 0-6) post-vaccination period following booster dose
Number of Subjects Reporting Any Medically Attended Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Measured: During the entire study period (Days 0-364) following the first vaccination
Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Measured: During the entire study period (Days 0-364) following first vaccination
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs).
Measured: At Days 0, 21, 42, 182 and 189
Number of Subjects Reporting Any Unsolicited AEs
Unsolicited AE covers any AE 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 any symptom regardless of intensity or relationship to vaccination.
Measured: During the 42-day (Days 0-41) follow up period after first vaccination.
Number of Subjects Reporting Any Unsolicited AEs
Unsolicited AE covers any AE 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 any symptom regardless of intensity or relationship to vaccination.
Measured: During the 21-day (Days 0-20) follow-up period after booster vaccination.
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the entire study period (Day 0 to Day 364)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study start1 Feb 2010
- Primary completion27 Sep 2010
- Study completion10 May 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 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
- NCT01035749
- Sponsor's protocol ID
- 113883
- Status last verified
- Nov 2016
- First submitted
- 17 Dec 2009
- Last updated
- 17 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Children Aged 10 to Less Than 18 Years
- ClinicalTrials.gov ID
- NCT01035749
- Acronym / sponsor ID
- 113883
- Conditions
- Influenza
- Keywords
- pandemic influenza, Clinical trial, H1N1, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2010
- Primary completion
- 27 Sep 2010 (actual)
- Study completion
- 10 May 2011 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Posted 25 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AREPANRIX-ADJUVANTED F1 2D GROUP | Experimental | Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A, Biological: Placebo (saline)Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| AREPANRIX-ADJUVANTED F2 2D GROUP | Experimental | Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A, Biological: Placebo (saline)Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| AREPANRIX-ADJUVANTED F2 3D GROUP | Experimental | Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274ASubjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). |
| AREPANRIX-UNADJUVANTED F2 2D GROUP | Experimental | Biological: GSK Biologicals' Influenza investigational vaccine GSK2340273A, Biological: Placebo (saline)Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female children 10 to < 18 years of age at the time of the first vaccination. "Less than 18 years of age" implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol.
- Written informed consent obtained from the subject's parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
- Good general health as established by medical history and clinical examination before entering into the study.
- Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
- Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol.
Key exclusion criteria (16 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 of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
- Presence of a temperature >= 38.0ºC 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.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
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' Influenza investigational vaccine GSK2340274AOne or two doses administered intramuscularly | Biological | AREPANRIX-ADJUVANTED F1 2D GROUP, AREPANRIX-ADJUVANTED F2 2D GROUP, AREPANRIX-ADJUVANTED F2 3D GROUP |
| GSK Biologicals' Influenza investigational vaccine GSK2340273ATwo doses intramuscularly | Biological | AREPANRIX-UNADJUVANTED F2 2D GROUP |
| Placebo (saline)One dose intramuscularly | Biological | AREPANRIX-ADJUVANTED F1 2D GROUP, AREPANRIX-ADJUVANTED F2 2D GROUP, AREPANRIX-UNADJUVANTED F2 2D GROUP |
Primary outcome
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Day 21
Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre
Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
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.
HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Day 21
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
25 secondary outcomes
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Day 0 and Day 42
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Day 0 and Day 182
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Days 0, 182 and 189
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Day 42
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Day 0 and Day 21
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Day 182
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Day 189
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Time frame: At Day 189
The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1
Time frame: At Day 0 and Day 42
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
Time frame: At Day 0 and Day 182
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
Time frame: At Day 0, Day 182 and Day 189
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1
Time frame: At Day 42
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1
Time frame: At Day 182
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity
Time frame: At Day 189
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity
Time frame: At Day 189
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
Time frame: During the 7-day (Days 0-6) post-vaccination period following booster dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Time frame: During the 7-day (Days 0-6) post-vaccination period following booster dose
Number of Subjects Reporting Any Medically Attended Events (MAEs)
Time frame: During the entire study period (Days 0-364) following the first vaccination
Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
Time frame: During the entire study period (Days 0-364) following first vaccination
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Time frame: At Days 0, 21, 42, 182 and 189
Number of Subjects Reporting Any Unsolicited AEs
Time frame: During the 42-day (Days 0-41) follow up period after first vaccination.
Number of Subjects Reporting Any Unsolicited AEs
Time frame: During the 21-day (Days 0-20) follow-up period after booster vaccination.
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 0 to Day 364)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK Biologicals' Influenza investigational vaccine GSK2340274A and GSK Biologicals' Influenza investigational vaccine GSK2340273A in people with Influenza, run by GlaxoSmithKline at 9 sites in 2 countries.
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 5 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 17 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 9 sites in Slovakia, Estonia. 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 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?
Yes. Results are posted in the registry (first posted 25 Jan 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?
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain (time frame: At Day 21). 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?
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 17 Aug 2018.