InfluenzaPhase 4NCT01190215

Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM

A Phase 4 study testing FluarixTM and HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old) in people with Influenza, run by GlaxoSmithKline at 1 site in Finland.

Completed

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

Official record

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Trial summary

This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been vaccinated with one dose of PandemrixTM at the age of 10-17 years. Read more about this study

Who is it for?: Ages 10 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: FluarixTM and HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteFinland
Study dates: 4 Oct 2010to 7 Jul 2011
Phase: Phase 4
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 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
Subjects having received Pandemrix at least six months prior to study enrolment.
Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects or Parent(s)/LAR(s) 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

Active participation in other clinical trials.
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.
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:
Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.

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Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
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.
History of seizures or progressive neurological disease.
Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
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.
Child in care.

Trial locations and contacts

1 site in 1 country.

Finland1 site

GSK Investigational Site
Tampere, 33100

Other trials in Finland

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine FluarixTM in Adolescents Previously Vaccinated With GSK Biologicals' H1N1 Vaccine PandemrixTM

Conditions: Influenza
Being tested: FluarixTM, HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)
Keywords: Influenza, Pandemrix, H1N1, Fluarix
Medical subject headings: Influenza, Human

What participants receive

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

FluarixTMBiological
One Intramuscular injection
HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)Biological
Two Intramuscular injections

Study groups in NCT01190215
Study group	Role	What they receive
Fluarix Group	Experimental	Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. Receives: Biological: FluarixTM
Havrix Group	Active comparator	Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0. Receives: Biological: HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)

What is being measured

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

Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
Day 28 data were presented only for the Fluarix Group.
Titres were expressed as geometric mean antibody titre.
Measured: At Day 0 and Day 28
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.
Day 28 data was presented only for the Fluarix Group.
Measured: At Day 0 and Day 28
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) 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.
Day 28 data were presented for the Fluarix Group only.
Measured: At Day 28
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Day 28 data were presented for the Fluarix Group only.
Measured: At Day 0 and Day 28
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Day 28 data were presented for the Fluarix Group only.
Measured: At Day 28

Secondary outcomes (27)

Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Titres were expressed as geometric mean antibody titres (GMTs).
Measured: At Day 0 and Day 28
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Titres were expressed as geometric mean antibody titres (GMTs).
Measured: At Day 0 and at Month 6
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.
Day 28 data were presented for the Fluarix Group only.
Measured: At Day 0 and Day 28
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Measured: At Day 0 and at Month 6
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) 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.
Day 28 data were presented for the Fluarix Group only.
Measured: At Day 28
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Measured: At Month 6
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Day 28 data were presented for the Fluarix Group only.
Measured: At Day 0 and Day 28
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Measured: At Day 0 and Month 6
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Day 28 data were presented for the Fluarix Group only.
Measured: At Day 28
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Measured: At Month 6
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Titres were expressed as geometric mean antibody titres (GMTs).
Measured: At Day 0 and at Day 28
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
Titres were expressed as geometric mean antibody titres (GMTs).
Measured: At Day 0 and at Month 6
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Measured: At Day 28
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
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 = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.
Measured: Within 7 days (Day 0 - Day 6) after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).
Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius.
Measured: Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Any Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling.
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Measured: Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain and swelling.
Grade 3 redness/swelling = redness/swelling above 50 millimetres.
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Measured: Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Any Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Measured: Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia.
Grade 3 symptom = general symptom that prevented normal activity.
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Measured: Within 7 days (Day 0 - Day 6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited adverse event is any adverse event (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.
Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Measured: Within 28 days (Day 0 - Day 27) after vaccination
Number of Subjects Reporting Medically-attended Events (MAEs).
For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Measured: Within the 28-day (Days 0-27) post-vaccination period
Number of Subjects Reporting Medically-attended Events (MAEs).
For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Measured: During the entire study period (Up to Month 6)
Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).
Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include 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 (Up to Month 6)
Number of Subjects Reporting Adverse Events of Special Interest.
Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.
Measured: During the entire study period (Up to Month 6)
Number of Subjects Reporting Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: Within the 28-day (Days 0-27) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: During the entire study period (Up to Month 6)

Timeline

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

4 Oct 20107 Jul 2011

First posted27 Aug 2010 (estimated)
Study start4 Oct 2010
Primary completion7 Jul 2011
Study completion7 Jul 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01190215
Sponsor's protocol ID: 114452
Status last verified: Aug 2017
First submitted: 26 Aug 2010
Last updated: 7 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Vesikari T, Richardus JH, Berglund J, Korhonen T, Flodmark CE, Lindstrand A, Silfverdal SA, Bambure V, Caplanusi A, Dieussaert I, Roy-Ghanta S, Vaughn DW. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015 Jul;34(7):774-82. doi: 10.1097/INF.0000000000000709.
PubMed 26069949

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 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine FluarixTM in Adolescents Previously Vaccinated With GSK Biologicals' H1N1 Vaccine PandemrixTM
ClinicalTrials.gov ID: NCT01190215
Acronym / sponsor ID: 114452
Conditions: Influenza
Keywords: Influenza, Pandemrix, H1N1, Fluarix
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 4 Oct 2010
Primary completion: 7 Jul 2011 (actual)
Study completion: 7 Jul 2011 (actual)
First posted: 27 Aug 2010 (estimated)
Results: Posted 13 Jul 2012

Clinical summary

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

Study design

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

Arm	Type	Receives
Fluarix Group	Experimental	Biological: FluarixTMSubjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Havrix Group	Active comparator	Biological: HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

Who may qualify

Ages: 10 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
Subjects having received Pandemrix at least six months prior to study enrolment.
Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (13 listed)

Active participation in other clinical trials.
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.
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
FluarixTMOne Intramuscular injection	Biological	Fluarix Group
HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)Two Intramuscular injections	Biological	Havrix Group

Primary outcome

Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Time frame: At Day 0 and Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Day 28 data were presented only for the Fluarix Group. Titres were expressed as geometric mean antibody titre.
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Time frame: At Day 0 and Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10. Day 28 data was presented only for the Fluarix Group.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Time frame: At Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroconverted subject was a subject who had either a pre-vaccination (Day 0) 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. Day 28 data were presented for the Fluarix Group only.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Time frame: At Day 0 and Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Day 28 data were presented for the Fluarix Group only.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Time frame: At Day 28
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Day 28 data were presented for the Fluarix Group only.

27 secondary outcomes

Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 0 and Day 28
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 0 and at Month 6
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 0 and Day 28
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 0 and at Month 6
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 28
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Month 6
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 0 and Day 28
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 0 and Month 6
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 28
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Month 6
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 0 and at Day 28
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 0 and at Month 6
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Day 28
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Time frame: At Month 6
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Time frame: Within 7 days (Day 0 - Day 6) after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Time frame: Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Any Solicited Local Symptoms.
Time frame: Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Grade 3 Solicited Local Symptoms.
Time frame: Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Any Solicited General Symptoms.
Time frame: Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Grade 3 Solicited General Symptoms.
Time frame: Within 7 days (Day 0 - Day 6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Time frame: Within 28 days (Day 0 - Day 27) after vaccination
Number of Subjects Reporting Medically-attended Events (MAEs).
Time frame: Within the 28-day (Days 0-27) post-vaccination period
Number of Subjects Reporting Medically-attended Events (MAEs).
Time frame: During the entire study period (Up to Month 6)
Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).
Time frame: During the entire study period (Up to Month 6)
Number of Subjects Reporting Adverse Events of Special Interest.
Time frame: During the entire study period (Up to Month 6)
Number of Subjects Reporting Serious Adverse Events (SAEs).
Time frame: Within the 28-day (Days 0-27) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAEs).
Time frame: During the entire study period (Up to Month 6)

Results and safety

Results posted to the registry on 13 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluarix Group	38	38
Havrix Group	39	39

Primary outcome: Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.

Time frame: At Day 0 and Day 28. Geometric mean (95% Confidence Interval). Unit: Titres

Measure	Fluarix Group n = 33	Havrix Group n = 39
Flu A/Cal/7/09 H1N1 [Day 0]	150.1 (105.8 to 213.0)	150.3 (106.0 to 213.3)
Flu A/Cal/7/09 H1N1 [Day 28]	646.8 (534.6 to 782.6)	NA (NA to NA)

Population analysed: The According-To-Protocol cohort for immunogenicity at Day 28 included subjects who received at least 1 vaccine dose, for whom data concerning immunogenicity outcome measures were available. It included subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 28 days after the vaccine dose.

Primary outcome: Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.

Time frame: At Day 0 and Day 28. Number. Unit: Subjects

Measure	Fluarix Group n = 33	Havrix Group n = 39
Flu A/Cal/7/09 H1N1 [Day 0]	33	39
Flu A/Cal/7/09 H1N1 [Day 28]	33	NA

Primary outcome: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.

Time frame: At Day 28. Number. Unit: Subjects

Measure	Fluarix Group n = 33	Havrix Group n = 0
Value	16	–

Primary outcome: Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.

Time frame: At Day 0 and Day 28. Number. Unit: Subjects

Measure	Fluarix Group n = 33	Havrix Group n = 39
Flu A/Cal/7/09 H1N1 [Day 0]	31	36
Flu A/Cal/7/09 H1N1 [Day 28]	33	NA

27 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were assessed up to Day 28 and during the entire study period, up to Month 6. Systematically and non-systematically assessed frequent adverse events were assessed during the 7 day and 28 day post-vaccination period respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluarix Group	1 of 38 (2.6%)	37 of 38 (97.4%)	Not reported
Havrix Group	0 of 39 (0%)	34 of 39 (87.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26069949Vesikari T, Richardus JH, Berglund J, Korhonen T, Flodmark CE, Lindstrand A, Silfverdal SA, Bambure V, Caplanusi A, Dieussaert I, Roy-Ghanta S, Vaughn DW. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015 Jul;34(7):774-82. doi: 10.1097/INF.0000000000000709.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

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

Questions about this trial

What is this clinical trial studying?

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 6 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 13 Jul 2012). 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?

Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain. (time frame: At Day 0 and Day 28). The study lists 5 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 NCT01190215, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.