InfluenzaPhase 3NCT00972517
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
A Phase 3 study testing GSK investigational vaccine GSK2340272A in people with Influenza, run by GlaxoSmithKline at 8 sites in Germany.
Trial summary
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- GSK investigational vaccine GSK2340272A
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 8 sitesGermany
- Study dates
- 29 Sep 2009to 22 Nov 2010
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
- Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- Healthy children as established by medical history and clinical examination when entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Who cannot join
- 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.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Show all 13Show fewer
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Previous administration of any H1N1 A/California-like vaccine.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- If the subject is female and 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 two months after completion of the vaccination series.
- 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.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
- Child in Care.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
GSK Investigational Site
Bindlach, Bavaria, 95463
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
About this study
Official title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Read the detailed description
This Protocol Posting has been updated following Protocol amendment 1, October 2009. The impacted section are the study design section, the outcomes measures section and the intervention section.
- Conditions
- Influenza
- Being tested
- GSK investigational vaccine GSK2340272A
- Keywords
- GSK Bio's influenza vaccine GSK2340272A, influenza infection
- 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 investigational vaccine GSK2340272ABiological
Three intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects receiving alternative dose of GSK23440272A vaccine Receives: Biological: GSK investigational vaccine GSK2340272A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Antibody titers were expressed as Geometric mean titers (GMTs).
Measured: At Day 0, Day 21 and Day 42
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
Measured: At Day 42
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
Measured: At Day 42
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
Measured: At Day 42
Secondary outcomes (17)
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Antibody titers were expressed as geometric mean titers (GMTs)
Measured: At Month 6
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Antibody titers were expressed as geometric mean titers (GMTs)
Measured: At Month 12
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
Measured: At Month 6
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
Measured: At Month 6
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
Measured: At Month 12
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
Measured: At Month 6
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Antibody titers were expressed as Geometric mean titers (GMTs).
Measured: At Day 0, Day 21, Day 42 and Month 6
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Antibody titers were expressed as Geometric mean titers (GMTs).
Measured: At Month 12
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
Measured: At Day 21 and Day 42
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
Measured: At Month 6
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. > 50mm.
Measured: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever [axillary temperature above 37.5 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 above 39.0°C.
Measured: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination.
Measured: During the entire study period (Day 0 to Month 12)
Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune etiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
Measured: During the entire study period (Day 0 to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Measured: Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Measured: During the entire study period (Day 0 to Month 12)
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown as measured by validated assay according to international standards.
Measured: At Day 0, Day 21, Day 42 and Month 6 (M6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study start29 Sep 2009
- Primary completion22 Nov 2010
- Study completion22 Nov 2010
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 (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 245 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
- NCT00972517
- Sponsor's protocol ID
- 113638
- Other IDs
- 2009-015011-41, 2009
- Status last verified
- Jun 2019
- First submitted
- 3 Sep 2009
- Last updated
- 26 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. doi: 10.1016/j.vaccine.2011.04.011. Epub 2011 Apr 17.
PubMed 21504774Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.
PubMed 26176592
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years
- ClinicalTrials.gov ID
- NCT00972517
- Acronym / sponsor ID
- 113638
- Conditions
- Influenza
- Keywords
- GSK Bio's influenza vaccine GSK2340272A, influenza infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2009 (actual)
- Primary completion
- 22 Nov 2010 (actual)
- Study completion
- 22 Nov 2010 (actual)
- First posted
- 7 Sep 2009 (estimated)
- Results
- Posted 10 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Detailed description
This Protocol Posting has been updated following Protocol amendment 1, October 2009. The impacted section are the study design section, the outcomes measures section and the intervention section.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: GSK investigational vaccine GSK2340272ASubjects receiving alternative dose of GSK23440272A vaccine |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
- Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- Healthy children as established by medical history and clinical examination when entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Key exclusion criteria (13 listed)
- 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.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of 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 |
|---|---|---|
| GSK investigational vaccine GSK2340272AThree intramuscular injections | Biological | Group A |
Primary outcome
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Time frame: At Day 0, Day 21 and Day 42
Antibody titers were expressed as Geometric mean titers (GMTs).
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Day 42
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Day 42
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Day 42
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
17 secondary outcomes
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Time frame: At Month 6
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Time frame: At Month 12
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Month 6
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Month 6
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Month 12
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
Time frame: At Month 6
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Time frame: At Day 0, Day 21, Day 42 and Month 6
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Time frame: At Month 12
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
Time frame: At Day 21 and Day 42
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
Time frame: At Month 6
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
Time frame: During the entire study period (Day 0 to Month 12)
Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs)
Time frame: During the entire study period (Day 0 to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Time frame: Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 0 to Month 12)
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Time frame: At Day 0, Day 21, Day 42 and Month 6 (M6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21504774Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. doi: 10.1016/j.vaccine.2011.04.011. Epub 2011 Apr 17.
- Background: PubMed 26176592Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.
- 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. IPD for this study will be made available via the Clinical Study Data Request site.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK investigational vaccine GSK2340272A in people with Influenza, run by GlaxoSmithKline at 8 sites in Germany.
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 13 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 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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 10 Sep 2018). 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?
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain (time frame: At Day 0, Day 21 and Day 42). The study lists 4 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 NCT00972517, which also lists 2 linked publications.
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 26 Jun 2019.