InfluenzaPhase 3NCT00383123

Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

A Phase 3 study testing Fluarix™ and Fluzone in people with Influenza, run by GlaxoSmithKline at 40 sites in United States.

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

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read more about this study

Who is it for?: Ages 6 months to 17 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluarix™ and Fluzone
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,327 participants
Where: 40 sitesUnited States
Study dates: 2 Nov 2006to 19 Oct 2007
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 6 months to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects > 10 years.
Female subjects of childbearing potential must agree to take a pregnancy test.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
History of hypersensitivity to any vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrollment.
History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
Pregnant or lactating female.
Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

GSK Investigational Site
Antioch, California, 94509
GSK Investigational Site
Austin, Texas, 78728
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Cary, North Carolina, 27518
GSK Investigational Site
Cleveland, Ohio, 44118
GSK Investigational Site
Englewood, Colorado, 80112
GSK Investigational Site
Fairfield, California, 94533
GSK Investigational Site
Fishkill, New York, 12524
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Fresno, California, 93710
GSK Investigational Site
Hopewell Junction, New York, 12533
GSK Investigational Site
Lakewood, Colorado, 80401
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Pleasanton, California, 94588
GSK Investigational Site
Poughkeepsie, New York, 12603
GSK Investigational Site
Redwood City, California, 94063
GSK Investigational Site
Richmond, California, 94801
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Rochester, New York, 14620
GSK Investigational Site
Rolling Hills Estates, California, 90274
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
San Angelo, Texas, 76904
GSK Investigational Site
San Francisco, California, 94102
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
Santa Rosa, California, 95403
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Sylva, North Carolina, 28779
GSK Investigational Site
Tifton, Georgia, 31794
GSK Investigational Site
Uniontown, Pennsylvania, 15401
GSK Investigational Site
Vacaville, California, 95688
GSK Investigational Site
Vallejo, California, 94589
GSK Investigational Site
Walnut Creek, California, 94596
GSK Investigational Site
West Jordan, Utah, 84084
GSK Investigational Site
Whitehouse Station, New Jersey, 08889

Other trials in United States

About this study

Official title: A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)

Conditions: Influenza
Being tested: Fluarix™, Fluzone
Keywords: Fluarix, Influenza
Medical subject headings: Influenza, Human

What participants receive

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

Fluarix™Biological
Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.
FluzoneBiological
Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.

Study groups in NCT00383123
Study group	Role	What they receive
Fluarix Group	Experimental	Subjects in this group received Fluarix™ and will be further stratified by 3 age groups * 1:1 in 6 months to < 36 months * 1:1 in 3 to < 5 years * 3:1 in 5 to < 18 years Receives: Biological: Fluarix™
Fluzone Group	Active comparator	Subjects in this group received Fluzone and will be further stratified by 3 age groups * 1:1 in 6 months to < 36 months * 1:1 in 3 to < 5 years * 3:1 in 5 to < 18 years Receives: Biological: Fluzone

What is being measured

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

Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Measured: 21 or 28 days after last vaccine dose
Number of Seroconverted Subjects
Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.
Data are presented for all 3 viral strains comprised in the vaccine.
Measured: 21 or 28 days after last vaccine dose
Number of Subjects Reporting Rare Serious Events
Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that:
- resulted in death,
- was life-threatening,
- required hospitalization or prolongation of existing hospitalization,
- resulted in disability/incapacity, or
- was a congenital anomaly/birth defect in the offspring of a study subject.
Measured: Up to 6 months after vaccination

Secondary outcomes (5)

Number of Seroprotected Subjects
Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.
Measured: Before (PRE) and 21 or 28 days after (POST) the last vaccine dose
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.
Measured: 21 or 28 days after last vaccine dose
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.
Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination.
Measured: During a 4-day follow-up period after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events
An Adverse Event is 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.
Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination.
Measured: Within 28 days following vaccination
Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)
SAE: any untoward medical occurrence that
- resulted in death,
- was life-threatening,
- required hospitalization or prolongation of existing hospitalization,
- resulted in disability/incapacity, or
- was a congenital anomaly/birth defect in the offspring of a study subject.
Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders.
Measured: Up to 6 months after vaccination

Timeline

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

2 Nov 200619 Oct 2007

First posted2 Oct 2006 (estimated)
Study start2 Nov 2006
Primary completion1 Oct 2007
Study completion19 Oct 2007

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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 3,327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00383123
Sponsor's protocol ID: 104858
Status last verified: Nov 2016
First submitted: 29 Sep 2006
Last updated: 8 Jun 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

Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.
PubMed 29465480
Baxter R, Jeanfreau R, Block SL, Blatter M, Pichichero M, Jain VK, Dewe W, Innis BL. A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children. Pediatr Infect Dis J. 2010 Oct;29(10):924-30. doi: 10.1097/INF.0b013e3181e075be.
PubMed 20431425

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 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)
ClinicalTrials.gov ID: NCT00383123
Acronym / sponsor ID: 104858
Conditions: Influenza
Keywords: Fluarix, Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,327 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 2 Nov 2006
Primary completion: 1 Oct 2007 (actual)
Study completion: 19 Oct 2007 (actual)
First posted: 2 Oct 2006 (estimated)
Results: Posted 4 Dec 2008

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: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Fluarix Group	Experimental	Biological: Fluarix™Subjects in this group received Fluarix™ and will be further stratified by 3 age groups * 1:1 in 6 months to < 36 months * 1:1 in 3 to < 5 years * 3:1 in 5 to < 18 years
Fluzone Group	Active comparator	Biological: FluzoneSubjects in this group received Fluzone and will be further stratified by 3 age groups * 1:1 in 6 months to < 36 months * 1:1 in 3 to < 5 years * 3:1 in 5 to < 18 years

Who may qualify

Ages: 6 months to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects > 10 years.
Female subjects of childbearing potential must agree to take a pregnancy test.

Key exclusion criteria (7 listed)

Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
History of hypersensitivity to any vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine.
Acute disease at the time of enrollment.
History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.

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
Fluarix™Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months. *Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.	Biological	Fluarix Group
FluzoneSubjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months. *Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.	Biological	Fluzone Group

Primary outcome

Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
Time frame: 21 or 28 days after last vaccine dose
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Number of Seroconverted Subjects
Time frame: 21 or 28 days after last vaccine dose
Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer <1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Data are presented for all 3 viral strains comprised in the vaccine.
Number of Subjects Reporting Rare Serious Events
Time frame: Up to 6 months after vaccination
Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that: * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject.

5 secondary outcomes

Number of Seroprotected Subjects
Time frame: Before (PRE) and 21 or 28 days after (POST) the last vaccine dose
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
Time frame: 21 or 28 days after last vaccine dose
Number of Subjects Reporting Solicited Local and General Symptoms
Time frame: During a 4-day follow-up period after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: Within 28 days following vaccination
Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)
Time frame: Up to 6 months after vaccination

Results and safety

Results posted to the registry on 4 Dec 2008, 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	2,115	2,004
Fluzone Group	1,210	1,124

Primary outcome: Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies

Time frame: 21 or 28 days after last vaccine dose. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Fluarix Group n = 426	Fluzone Group n = 445
A/New Caledonia [6 to <36 months]	52.4 (43.3 to 63.4)	101.4 (86.9 to 118.2)
A/Wisconsin [6 to <36 months]	80.5 (62.2 to 104.1)	218.0 (185.8 to 255.8)
B/Malaysia [6 to <36 months]	20.2 (15.9 to 25.8)	40.6 (32.3 to 51.1)
A/New Caledonia [3 to < 5 years]	130.3 (108.6 to 156.4)	168.7 (138.7 to 205.2)
A/Wisconsin [3 to < 5 years]	458.1 (365.3 to 574.3)	483.4 (396.8 to 588.9)
B/Malaysia [3 to < 5 years]	54.9 (42.3 to 71.1)	64.4 (49.5 to 83.8)

Population analysed: Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to \< 5 years).

Primary outcome: Number of Seroconverted Subjects

Time frame: 21 or 28 days after last vaccine dose. Count of participants. Unit: Participants

Measure	Fluarix Group n = 425	Fluzone Group n = 443
A/New Caledonia [6 to <36 months]	105	179
A/Wisconsin [6 to <36 months]	117	190
B/Malaysia [6 to <36 months]	48	114
A/New Caledonia [3 to <5 years]	160	159
A/Wisconsin [3 to <5 years]	156	155
B/Malaysia [3 to <5 years]	117	122

Population analysed: As per protocol, seroconversion was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to \< 5 years for whom post-vaccination results were available.

Primary outcome: Number of Subjects Reporting Rare Serious Events

Time frame: Up to 6 months after vaccination. Count of participants. Unit: Participants

Measure	Fluarix Group n = 2115	Fluzone Group n = 1210
Value	11	11

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluarix Group	11 of ?	1,480 of 2,115 (70%)	0
Fluzone Group	11 of ?	781 of 1,210 (64.5%)	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29465480Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.
Derived from this study: PubMed 20431425Baxter R, Jeanfreau R, Block SL, Blatter M, Pichichero M, Jain VK, Dewe W, Innis BL. A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children. Pediatr Infect Dis J. 2010 Oct;29(10):924-30. doi: 10.1097/INF.0b013e3181e075be.
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

40 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 Fluarix™ and Fluzone in people with Influenza, run by GlaxoSmithKline at 40 sites in United States.

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 4 inclusion and 7 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. 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 4 Dec 2008). 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 Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies (time frame: 21 or 28 days after last vaccine dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00383123, 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 8 Jun 2018.