InfluenzaPhase 3NCT00521586

Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine

A Phase 3 study testing 13 valent pneumococcal conjugate vaccine in people with Influenza, run by Pfizer at 41 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

Who is it for?: Ages 50 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: 13 valent pneumococcal conjugate vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,116 participants
Where: 41 sitesUnited States
Study dates: Sep 2007to Dec 2013
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 50 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female aged 50 to 59 years
Determined by medical history, physical examination and clinical judgement to be eligible for the study
Able to complete electronic diary
Available for the 5 year 9 month duration of the study

Who cannot join

Previous vaccination with any licensed or experimental pneumococcal vaccine
Allergic to egg proteins and chicken proteins
History of Guillian-Barre syndrome
Vaccination with TIV within 6 months before study start
Vaccination with diphtheria-containing vaccine within 6 months of study start
Serious chronic disorders including immunodeficiency or metastatic malignancy
Known or suspected hypersensitivity to any vaccine or vaccine component

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials
Aurora, Colorado, 80045-7144
Internal Medicine & Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620
PMG Research of Bristol, LLC
Bristol, Tennessee, 37620
Big Sky Clinical Research
Butte, Montana, 59701
FFM Clinical Research
Camillus, New York, 13031
Preferred Primary Care Physicians, Inc
Carnegie, Pennsylvania, 15106
PMG Research of Raleigh, LLC
Cary, North Carolina, 27518
Clinical Research Advantage, Inc.
Chandler, Arizona, 85224
Cincinnati Children's Hospital Medical Center Gamble Program for Clinical Studies
Cincinnati, Ohio, 45206
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Prestige Clinical Research
Franklin, Ohio, 45005
Family Healthcare Partners
Grove City, Pennsylvania, 16127
A. G. A. Clinical Trials
Hialeah, Florida, 33012
Hickory Family Practice Associates
Hickory, North Carolina, 28601
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601
Unifour Medical Research Associates, LLC
Hickory, North Carolina, 28601
Unifour Medical Research Associates
Hickory, North Carolina, 28601
Fairbrook Medical Clinic
Hickory, North Carolina, 28602
PMG Research of Hickory, LLC
Hickory, North Carolina, 28602
Unifour Medical Research Associates, LLC
Hickory, North Carolina, 28602
Clark D. McKeever, M.D. Research for Health
Houston, Texas, 77055-6040
Family Practice Medical Associates South, Jefferson Office
Jefferson Hills, Pennsylvania, 15025
Volunteer Research Group
Knoxville, Tennessee, 37920
Advanced Clinical Research
Meridian, Idaho, 83642
Accelovance
Peoria, Illinois, 61602
Kid's Plus Pediatrics
Pittsburgh, Pennsylvania, 15217
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, 15241
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
Suite 100
Riverdale, Maryland, 20737
Mayo Clinic
Rochester, Minnesota, 55905
Rochester Clinical Research
Rochester, New York, 14609
University of Rochester Medical Center
Rochester, New York, 14642
Peninsula Research Associates
Rolling Hills Estates, California, 90274
PMG Research of Salisbury
Salisbury, North Carolina, 28144
Diagnostics Research Group
San Antonio, Texas, 78229
Radiant Research, Inc
St Louis, Missouri, 63141
Family Practice Medical Associates South
Upper Saint Clair, Pennsylvania, 15241
The Washington Hospital Family Medicine
Washington, Pennsylvania, 15301
Advanced Clinical Research
West Jordan, Utah, 84088
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination

This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.

Conditions: Influenza
Being tested: 13 valent pneumococcal conjugate vaccine
Keywords: Pneumococcal Conjugate 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.

13 valent pneumococcal conjugate vaccineBiological
Also called 0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscle
TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
13 valent pneumococcal conjugate vaccineBiological
Also called 0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscle
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5

Study groups in NCT00521586
Study group	Role	What they receive
1	Other	arm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5 Receives: Biological: 13 valent pneumococcal conjugate vaccine
2	Other	arm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5 Receives: Biological: 13 valent pneumococcal conjugate vaccine

What is being measured

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

Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1
Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.
Measured: 1 month after Dose 1
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Measured: 1 month after 13vPnC Dose at year 0

Timeline

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

Sep 2007Dec 2013

First posted28 Aug 2007 (estimated)
Study startSep 2007
Primary completionDec 2013
Study completionDec 2013

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 PfizerThe 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: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00521586
Sponsor's protocol ID: 6115A1-3001
Other IDs: B1851020
Status last verified: Apr 2015
First submitted: 24 Aug 2007
Last updated: 9 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Frenck RW Jr, Fiquet A, Gurtman A, van Cleeff M, Davis M, Rubino J, Smith W, Sundaraiyer V, Sidhu M, Emini EA, Gruber WC, Scott DA, Schmoele-Thoma B; B1851020 Study Group. Immunogenicity and safety of a second administration of 13-valent pneumococcal conjugate vaccine 5 years after initial vaccination in adults 50 years and older. Vaccine. 2016 Jun 24;34(30):3454-62. doi: 10.1016/j.vaccine.2016.04.093. Epub 2016 May 5.
PubMed 27155493
Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schmole-Thoma B. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012 Aug;19(8):1296-303. doi: 10.1128/CVI.00176-12. Epub 2012 Jun 27.
PubMed 22739693

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 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination
ClinicalTrials.gov ID: NCT00521586
Acronym / sponsor ID: 6115A1-3001
Conditions: Influenza
Keywords: Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,116 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 28 Aug 2007 (estimated)
Results: Posted 9 Apr 2015

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: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Other	Biological: 13 valent pneumococcal conjugate vaccinearm 1 = TIV +13vPnC at visit 1, placebo at visit 2 then 13vPnC at year 5
2	Other	Biological: 13 valent pneumococcal conjugate vaccinearm 2 = TIV + placebo at visit 1, then 13vPnC at visit 2 and at year 5

Who may qualify

Ages: 50 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male or female aged 50 to 59 years
Determined by medical history, physical examination and clinical judgement to be eligible for the study
Able to complete electronic diary
Available for the 5 year 9 month duration of the study

Key exclusion criteria (7 listed)

Previous vaccination with any licensed or experimental pneumococcal vaccine
Allergic to egg proteins and chicken proteins
History of Guillian-Barre syndrome
Vaccination with TIV within 6 months before study start
Vaccination with diphtheria-containing vaccine within 6 months of study start

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
13 valent pneumococcal conjugate vaccineAlso: 0.5 mL dose of TIV and 13vPnC at dose 1, 0.5 mL dose of of placebo at dose 2, and 0.5ml dose of 13vPnC at year 5 will be administered into left deltoid muscleTIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5	Biological	1
13 valent pneumococcal conjugate vaccineAlso: 0.5 mL dose of TIV and of placebo at dose 1 and 0.5 mL dose of 13vPnC at dose 2 and year 5 will be administered into left deltoid muscleTIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5	Biological	2

Primary outcome

Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1
Time frame: 1 month after Dose 1
Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose
Time frame: 1 month after 13vPnC Dose at year 0
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Results and safety

Results posted to the registry on 9 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)	554	533
Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)	562	533

Primary outcome: Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1

Time frame: 1 month after Dose 1. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5) n = 530	Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5) n = 531
A/H1N1 strain (n=445,431)	84.0 (80.6 to 87.0)	81.2 (77.6 to 84.4)
A/H3N2 strain (n=377,369)	71.1 (67.1 to 75.0)	69.5 (65.4 to 73.4)
B strain (n=321,320)	60.6 (56.3 to 64.8)	60.3 (56.0 to 64.5)

13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5) vs Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5): percent difference: 2.8 (95% CI -1.8 to 7.4)
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5) vs Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5): percent difference: 1.6 (95% CI -3.9 to 7.2)
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5) vs Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5): percent difference: 0.3 (95% CI -5.6 to 6.2)

Population analysed: Evaluable immunogenicity population:eligible participants who received vaccination as assigned;had blood drawn within pre-specified time-frames;had at least 1 valid,determinate assay result;had no major protocol violation.

Primary outcome: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose

Time frame: 1 month after 13vPnC Dose at year 0. Geometric mean (95% Confidence Interval). Unit: microgram per milliliter (mcg/mL)

Measure	13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5) n = 531	Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5) n = 532
Serotype 1 (n=292, 289)	4.05 (3.41 to 4.81)	5.45 (4.57 to 6.49)
Serotype 3 (n=290, 288)	1.15 (1.02 to 1.29)	1.46 (1.29 to 1.65)
Serotype 4 (n=290, 288)	2.35 (2.00 to 2.77)	3.41 (2.89 to 4.02)
Serotype 5 (n=293, 289)	6.03 (5.16 to 7.05)	7.18 (6.13 to 8.40)
Serotype 6A (n=293, 288)	5.78 (5.02 to 6.64)	6.70 (5.74 to 7.83)
Serotype 6B (n=292, 289)	7.58 (6.54 to 8.78)	10.09 (8.57 to 11.86)
Serotype 7F (n=293, 289)	8.14 (7.07 to 9.38)	10.57 (9.11 to 12.27)
Serotype 9V (n=293, 289)	4.96 (4.32 to 5.70)	6.97 (6.08 to 7.99)

13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5) vs Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5): Geometric mean ratio: 0.74 (95% CI 0.58 to 0.95)
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5) vs Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5): Geometric mean ratio: 0.79 (95% CI 0.66 to 0.93)
13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5) vs Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5): Geometric mean ratio: 0.69 (95% CI 0.55 to 0.87)

Adverse events

Time frame: AEs/SAEs recorded: All AEs for 1 month postvaccination. All SAEs and newly diagnosed chronic medical conditions for 6 months postvaccination. Deaths and withdrawals due to S/AE in Years 1-4. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC+TIV/Placebo: Dose 1 (Year 0)	4 of 551 (0.7%)	420 of 551 (76.2%)	Not reported
13vPnC+TIV/Placebo: Dose 2 (Year 0)	3 of 538 (0.6%)	248 of 538 (46.1%)	Not reported
13vPnC+TIV/Placebo: 6 Month Follow-up (Year 0)	18 of 538 (3.3%)	26 of 538 (4.8%)	Not reported
13vPnC+TIV/Placebo: Years 1-4	8 of 536 (1.5%)	1 of 536 (0.2%)	Not reported
13vPnC+TIV/Placebo: 13vPnC (Year 5)	2 of 364 (0.5%)	256 of 364 (70.3%)	Not reported
13vPnC+TIV/Placebo: 6 Month Follow-up (Year 5)	2 of 364 (0.5%)	1 of 364 (0.3%)	Not reported
Placebo+TIV/13vPnC: Dose 1 (Year 0)	5 of 560 (0.9%)	326 of 560 (58.2%)	Not reported
Placebo+TIV/13vPnC: Dose 2 (Year 0)	6 of 543 (1.1%)	388 of 543 (71.5%)	Not reported
Placebo+TIV/13vPnC: 6 Month Follow-up (Year 0)	10 of 543 (1.8%)	29 of 543 (5.3%)	Not reported
Placebo+TIV/13vPnC: Years 1-4	3 of 542 (0.6%)	0 of 542 (0%)	Not reported
Placebo+TIV/13vPnC: 13vPnC (Year 5)	2 of 363 (0.6%)	248 of 363 (68.3%)	Not reported
Placebo+TIV/13vPnC: 6 Month Follow-up (Year 5)	3 of 363 (0.8%)	0 of 363 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27155493Frenck RW Jr, Fiquet A, Gurtman A, van Cleeff M, Davis M, Rubino J, Smith W, Sundaraiyer V, Sidhu M, Emini EA, Gruber WC, Scott DA, Schmoele-Thoma B; B1851020 Study Group. Immunogenicity and safety of a second administration of 13-valent pneumococcal conjugate vaccine 5 years after initial vaccination in adults 50 years and older. Vaccine. 2016 Jun 24;34(30):3454-62. doi: 10.1016/j.vaccine.2016.04.093. Epub 2016 May 5.
Derived from this study: PubMed 22739693Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schmole-Thoma B. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012 Aug;19(8):1296-303. doi: 10.1128/CVI.00176-12. Epub 2012 Jun 27.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

41 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 13 valent pneumococcal conjugate vaccine in people with Influenza, run by Pfizer at 41 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 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 9 Apr 2015). 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?

Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1 (time frame: 1 month after Dose 1). The study lists 2 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 NCT00521586, 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 9 Apr 2015.