InfluenzaPhase 2NCT00971321

Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

A Phase 2 study testing Pandemic influenza vaccine GSK2340272A in people with Influenza, run by GlaxoSmithKline at 5 sites in Spain.

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 trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months. This protocol posting has been updated following protocol amendment 4, March 2010. Read more about this study

Who is it for?: Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Pandemic influenza vaccine GSK2340272A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 157 participants
Where: 5 sitesSpain
Study dates: 10 Sep 2009to 24 Nov 2010
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 6 to 35 months
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 6 and 35 months at the time of first study vaccination.
Written informed consent obtained from the parent(s) or LAR(s) of the subject.
Healthy children, as established by medical history and clinical examination when entering 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.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.

Show all 13Show fewer

History of hypersensitivity to vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
History of any neurological disorders or seizures.
Acute disease and/or fever at the time of enrolment
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
Child in Care.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Spain5 sites

GSK Investigational Site
Bilbao, 48013
GSK Investigational Site
Burgos, 09005
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Móstoles/Madrid, 28935
GSK Investigational Site
Seville, 41013

Other trials in Spain

About this study

Official title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 6 to 35 Months

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.

This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.

Conditions: Influenza
Being tested: Pandemic influenza vaccine GSK2340272A
Keywords: influenza infection, GSK Bio's influenza vaccine GSK2340272A
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pandemic influenza vaccine GSK2340272ABiological
Two primary intramuscular (IM) injections

Study groups in NCT00971321
Study group	Role	What they receive
GSK 2340272A F1 Group	Experimental	Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry. Receives: Biological: Pandemic influenza vaccine GSK2340272A
GSK 2340272A F2 Group	Experimental	Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry. Receives: Biological: Pandemic influenza vaccine GSK2340272A

What is being measured

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

Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Day 0
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Day 42
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Day 0
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Day 42
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies
Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Day 42
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Day 42
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Day 42

Secondary outcomes (16)

Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Days 0, 21, 42, and at Month 11-12
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Days 0, 21, 42 and at Month 11-12
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Days 21, 42 and at Month 11-12
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Days 0, 21, 42 and at Month 11-12
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).
Measured: At Days 21, 42 and at Month 11-12
Titers for Serum Neutralising Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.
Measured: At Days 0, 21 and 42
Titers for Serum Neutralising Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.
Measured: At Days 0, 21, 42 and at Month 11-12
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.
Measured: At Days 21 and 42
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.
Measured: At Days 21, 42 and at Month 11-12
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 = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Measured: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
Number of Subjects With 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. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Measured: During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs)
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. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Measured: During the entire study period (Day 0 up to Month 11-12)
Number of Subjects With Normal/Abnormal Biochemical Levels
Among biochemical parameters assessed were: alanine aminotrasferase [ALAT], aspartate aminotransferase [ASAT], bilirubin total [BIL/T], bilirubin direct [BIL/D], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above.
Measured: At Days 0, 21 and 42
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 a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84)
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (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 (Day 0 up to Month 11-12)

Timeline

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

10 Sep 200924 Nov 2010

First posted3 Sep 2009 (estimated)
Study start10 Sep 2009
Primary completion24 Nov 2010
Study completion24 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00971321
Sponsor's protocol ID: 113462
Status last verified: Aug 2018
First submitted: 27 Aug 2009
Last updated: 25 Feb 2019
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

Garcia-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
Carmona A, Omenaca F, Tejedor JC, Merino JM, Vaman T, Dieussaert I, Gillard P, Aristegui J. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine. 2010 Aug 16;28(36):5837-44. doi: 10.1016/j.vaccine.2010.06.065. Epub 2010 Jun 29.
PubMed 20600478

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 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 6 to 35 Months
ClinicalTrials.gov ID: NCT00971321
Acronym / sponsor ID: 113462
Conditions: Influenza
Keywords: influenza infection, GSK Bio's influenza vaccine GSK2340272A
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 10 Sep 2009
Primary completion: 24 Nov 2010 (actual)
Study completion: 24 Nov 2010 (actual)
First posted: 3 Sep 2009 (estimated)
Results: Posted 25 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.

This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GSK 2340272A F1 Group	Experimental	Biological: Pandemic influenza vaccine GSK2340272AHealthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
GSK 2340272A F2 Group	Experimental	Biological: Pandemic influenza vaccine GSK2340272AHealthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.

Who may qualify

Ages: 6 to 35 months
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 6 and 35 months at the time of first study vaccination.
Written informed consent obtained from the parent(s) or LAR(s) of the subject.
Healthy children, as established by medical history and clinical examination when entering 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.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

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
Pandemic influenza vaccine GSK2340272ATwo primary intramuscular (IM) injections	Biological	GSK 2340272A F1 Group, GSK 2340272A F2 Group

Primary outcome

Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Time frame: At Day 0
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Time frame: At Day 42
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Time frame: At Day 0
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Time frame: At Day 42
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies
Time frame: At Day 42
Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Time frame: At Day 42
Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Time frame: At Day 42
Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).

16 secondary outcomes

Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Time frame: At Days 0, 21, 42, and at Month 11-12
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Time frame: At Days 0, 21, 42 and at Month 11-12
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Time frame: At Days 21, 42 and at Month 11-12
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Time frame: At Days 0, 21, 42 and at Month 11-12
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Time frame: At Days 21, 42 and at Month 11-12
Titers for Serum Neutralising Antibodies
Time frame: At Days 0, 21 and 42
Titers for Serum Neutralising Antibodies
Time frame: At Days 0, 21, 42 and at Month 11-12
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
Time frame: At Days 21 and 42
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
Time frame: At Days 21, 42 and at Month 11-12
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period after 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 after each dose and across doses
Number of Subjects With Any Medically-attended Events (MAEs)
Time frame: During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs)
Time frame: During the entire study period (Day 0 up to Month 11-12)
Number of Subjects With Normal/Abnormal Biochemical Levels
Time frame: At Days 0, 21 and 42
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84)
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 0 up to Month 11-12)

Results and safety

Results posted to the registry on 25 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK2340272A F1 Group	104	104
GSK2340272A F2 Group	53	53

Primary outcome: Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies

Time frame: At Day 0. Count of participants. Unit: Participants

Measure	GSK2340272A F1 Group n = 101	GSK2340272A F2 Group n = 48
Value	5	6

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Primary outcome: Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies

Time frame: At Day 42. Count of participants. Unit: Participants

Measure	GSK2340272A F1 Group n = 97	GSK2340272A F2 Group n = 50
Value	97	50

Primary outcome: Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies

Time frame: At Day 0. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	GSK2340272A F1 Group n = 101	GSK2340272A F2 Group n = 48
Value	5.75 (5.00 to 6.63)	6.82 (5.22 to 8.91)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjeects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Primary outcome: Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies

Time frame: At Day 42. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	GSK2340272A F1 Group n = 97	GSK2340272A F2 Group n = 50
Value	2007.70 (1805.24 to 2232.87)	2259.61 (1947.61 to 2621.59)

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK 2340272A F1 Group	2 of 104 (1.9%)	103 of 104 (99%)	0 of 104
GSK 2340272A F2 Group	6 of 53 (11.3%)	53 of 53 (100%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: 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.
Derived from this study: PubMed 20600478Carmona A, Omenaca F, Tejedor JC, Merino JM, Vaman T, Dieussaert I, Gillard P, Aristegui J. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine. 2010 Aug 16;28(36):5837-44. doi: 10.1016/j.vaccine.2010.06.065. Epub 2010 Jun 29.
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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pandemic influenza vaccine GSK2340272A in people with Influenza, run by GlaxoSmithKline at 5 sites in Spain.

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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. 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 Feb 2019). 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 Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies (time frame: At Day 0). The study lists 7 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 NCT00971321, 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 25 Feb 2019.