InfluenzaPhase 1NCT00510874

Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults

A Phase 1 study testing Pumarix™ and Pandemrix ™ in people with Influenza, run by GlaxoSmithKline at 10 sites in 2 countries.

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 evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. 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 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Pumarix™ and Pandemrix ™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 780 participants
Where: 10 sitesin 2 countries
Study dates: 28 Jul 2007to 24 Oct 2008
Phase: Phase 1
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 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
Good general health as assessed by medical history and physical examination.
Access to a consistent means of telephone contact
Written informed consent obtained from the subject.
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Who cannot join

Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Blood pressure abnormalities
Diagnosed with cancer, or treatment for cancer, within 3 years.
Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll, but other histologic types of skin cancer are exclusionary.

Show all 19Show fewer

Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
Presence of an oral temperature ≥ 37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Receipt of cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
Administration of any non-influenza vaccines within 30 days before study enrollment or during the study period.
Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the study period.
Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
Any known or suspected allergy to any constituent of influenza vaccines.
Known pregnancy or a positive urine beta-human chorionic gonadotropin (ß-hCG) test result prior to dosing on Study Days 0 or 21.
Lactating or nursing.
Women of child bearing potential who lack a history of reliable contraceptive practices.
Known receipt of analgesic or antipyretic medication on the day of treatment

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

United States7 sites

GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Huntsville, Alabama, 35802
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
Missoula, Montana, 59801
GSK Investigational Site
Stockbridge, Georgia, 30281

Other trials in United States

Canada3 sites

GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Sherbrooke, Quebec, J1H 4J6
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2

Other trials in Canada

About this study

Official title: A Phase I/II, Observer-Blind, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Two-Dose Series of GSK Biologicals' Candidate Influenza Vaccine GSK 1557484A Antigens With or Without Adjuvant

Read the detailed description

The study has five core arms and the stratification is based on site and age. In addition, there are 4 possible contingent groups of which 2 will be studied based on an analysis concerning immunogenicity performance at Day 42 in core groups above.

Conditions: Influenza
Being tested: Pumarix™, Pandemrix ™
Keywords: Influenza, GSK 1557484A vaccine
Medical subject headings: Influenza, Human

What participants receive

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

Pumarix™Biological
Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.
Pandemrix ™Biological
Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.

Study groups in NCT00510874
Study group	Role	What they receive
Pumarix Formulation 1 Group	Experimental	Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Receives: Biological: Pumarix™
Pumarix Formulation 2 Group	Experimental	Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Receives: Biological: Pumarix™
Pumarix Formulation 3 Group	Experimental	Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Receives: Biological: Pumarix™
Pandemrix Formulation A Group	Experimental	Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Receives: Biological: Pandemrix ™
Pandemrix Formulation B Group	Experimental	Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Receives: Biological: Pandemrix ™
Pumarix Formulation 4 Group	Experimental	Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Receives: Biological: Pumarix™
Pumarix Formulation 5 Group	Experimental	Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Receives: Biological: Pumarix™

What is being measured

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

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
Measured: At Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
Measured: At Day 42
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
Measured: At Day 42
Number of Subjects With Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).
Measured: Within the 7-day follow-up period (Days 0-6) after any vaccination
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.
Measured: Within the 7-day follow-up period (Days 0-6) after any vaccination
Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).
A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.
Measured: From Day 0 to 182
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an 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 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.
Measured: During the 21-day follow-up period (Days 0-20) after vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an 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 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.
Measured: Between Day 0 and Day 84 after vaccination.
Number of Subjects With Any Serious Adverse Events (SAEs).
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.
Measured: From Day 0 to 182

Secondary outcomes (4)

Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
Measured: At Day 21 and Day 182
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
Measured: At Days 21 and 182
Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.
Measured: At Days 21 and 182
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.
Measured: At Days 0, 21 and 182

Timeline

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

28 Jul 200724 Oct 2008

First posted2 Aug 2007 (estimated)
Study start28 Jul 2007
Primary completion17 Jun 2008
Study completion24 Oct 2008

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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 780 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00510874
Sponsor's protocol ID: 110028
Status last verified: Oct 2016
First submitted: 1 Aug 2007
Last updated: 17 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Langley JM, Frenette L, Ferguson L, Riff D, Sheldon E, Risi G, Johnson C, Li P, Kenney R, Innis B, Fries L. Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults. J Infect Dis. 2010 Jun 1;201(11):1644-53. doi: 10.1086/652701.
PubMed 20423222

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 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, Observer-Blind, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Two-Dose Series of GSK Biologicals' Candidate Influenza Vaccine GSK 1557484A Antigens With or Without Adjuvant
ClinicalTrials.gov ID: NCT00510874
Acronym / sponsor ID: 110028
Conditions: Influenza
Keywords: Influenza, GSK 1557484A vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 780 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Jul 2007
Primary completion: 17 Jun 2008 (actual)
Study completion: 24 Oct 2008 (actual)
First posted: 2 Aug 2007 (estimated)
Results: Posted 7 Feb 2014

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
Pumarix Formulation 1 Group	Experimental	Biological: Pumarix™Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 2 Group	Experimental	Biological: Pumarix™Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 3 Group	Experimental	Biological: Pumarix™Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pandemrix Formulation A Group	Experimental	Biological: Pandemrix ™Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pandemrix Formulation B Group	Experimental	Biological: Pandemrix ™Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 4 Group	Experimental	Biological: Pumarix™Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 5 Group	Experimental	Biological: Pumarix™Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
Good general health as assessed by medical history and physical examination.
Access to a consistent means of telephone contact
Written informed consent obtained from the subject.
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

Key exclusion criteria (19 listed)

Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Blood pressure abnormalities
Diagnosed with cancer, or treatment for cancer, within 3 years.
Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.

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
Pumarix™Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.	Biological	Pumarix Formulation 1 Group, Pumarix Formulation 2 Group, Pumarix Formulation 3 Group, Pumarix Formulation 4 Group, Pumarix Formulation 5 Group
Pandemrix ™Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.	Biological	Pandemrix Formulation A Group, Pandemrix Formulation B Group

Primary outcome

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Time frame: At Day 42
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Time frame: At Day 42
Titers are presented as geometric mean titers (GMTs).
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Time frame: At Day 42
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
Number of Subjects With Solicited Local Symptoms.
Time frame: Within the 7-day follow-up period (Days 0-6) after any vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).
Number of Subjects With Solicited General Symptoms.
Time frame: Within the 7-day follow-up period (Days 0-6) after any vaccination
Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.
Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).
Time frame: From Day 0 to 182
A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.
Number of Subjects With Unsolicited Adverse Events (AEs).
Time frame: During the 21-day follow-up period (Days 0-20) after vaccination.
An unsolicited AE was defined as an 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 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.
Number of Subjects With Unsolicited Adverse Events (AEs).
Time frame: Between Day 0 and Day 84 after vaccination.
An unsolicited AE was defined as an 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 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.
Number of Subjects With Any Serious Adverse Events (SAEs).
Time frame: From Day 0 to 182
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.

4 secondary outcomes

Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Time frame: At Day 21 and Day 182
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Time frame: At Days 21 and 182
Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Time frame: At Days 21 and 182
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Time frame: At Days 0, 21 and 182

Results and safety

Results posted to the registry on 7 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pumarix Formulation 1 Group	78	75
Pumarix Formulation 2 Group	152	148
Pumarix Formulation 3 Group	151	150
Pandemrix Formulation A Group	151	148
Pandemrix Formulation B Group	148	141
Pumarix Formulation 4 Group	50	50
Pumarix Formulation 5 Group	50	49

Primary outcome: Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

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

Measure	Pumarix Formulation 1 Group n = 75	Pumarix Formulation 2 Group n = 144	Pumarix Formulation 3 Group n = 146	Pandemrix Formulation A Group n = 140	Pandemrix Formulation B Group n = 142	Pumarix Formulation 4 Group n = 49	Pumarix Formulation 5 Group n = 50
Value	13	140	131	135	131	47	42

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

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

Measure	Pumarix Formulation 1 Group n = 75	Pumarix Formulation 2 Group n = 144	Pumarix Formulation 3 Group n = 146	Pandemrix Formulation A Group n = 140	Pandemrix Formulation B Group n = 142	Pumarix Formulation 4 Group n = 49	Pumarix Formulation 5 Group n = 50
Value	10.5 (8.2 to 13.5)	464.7 (383.4 to 563.4)	320.7 (246.9 to 416.6)	480.3 (390.5 to 590.7)	347.7 (272 to 444.5)	331.6 (217.4 to 505.6)	173.9 (105.6 to 286.3)

Primary outcome: Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

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

Measure	Pumarix Formulation 1 Group n = 75	Pumarix Formulation 2 Group n = 144	Pumarix Formulation 3 Group n = 146	Pandemrix Formulation A Group n = 140	Pandemrix Formulation B Group n = 142	Pumarix Formulation 4 Group n = 49	Pumarix Formulation 5 Group n = 50
Value	13	140	131	135	131	47	42

Primary outcome: Number of Subjects With Solicited Local Symptoms.

Time frame: Within the 7-day follow-up period (Days 0-6) after any vaccination. Count of participants. Unit: Participants

Measure	Pumarix Formulation 1 Group n = 78	Pumarix Formulation 2 Group n = 152	Pumarix Formulation 3 Group n = 151	Pandemrix Formulation A Group n = 151	Pandemrix Formulation B Group n = 148	Pumarix Formulation 4 Group n = 50	Pumarix Formulation 5 Group n = 50
Any Pain	18	133	130	139	124	48	42
Any Redness	0	7	2	9	6	1	0
Any Swelling	0	12	10	21	9	4	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pumarix Formulation 1 Group	0 of 78 (0%)	45 of 78 (57.7%)	Not reported
Pumarix Formulation 2 Group	2 of 152 (1.3%)	137 of 152 (90.1%)	Not reported
Pumarix Formulation 3 Group	1 of 151 (0.7%)	132 of 151 (87.4%)	Not reported
Pandemrix Formulation A Group	2 of 151 (1.3%)	146 of 151 (96.7%)	Not reported
Pandemrix Formulation B Group	1 of 148 (0.7%)	131 of 148 (88.5%)	Not reported
Pumarix Formulation 4 Group	1 of 50 (2%)	48 of 50 (96%)	Not reported
Pumarix Formulation 5 Group	0 of 50 (0%)	42 of 50 (84%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20423222Langley JM, Frenette L, Ferguson L, Riff D, Sheldon E, Risi G, Johnson C, Li P, Kenney R, Innis B, Fries L. Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults. J Infect Dis. 2010 Jun 1;201(11):1644-53. doi: 10.1086/652701.
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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BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

Referral and contact

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

GSK Clinical Trials study director

GlaxoSmithKline

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pumarix™ and Pandemrix ™ in people with Influenza, run by GlaxoSmithKline at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 7 Feb 2014). 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 Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. (time frame: At Day 42). The study lists 9 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 NCT00510874, 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 17 Aug 2018.