Orthomyxoviridae InfectionPhase 3NCT00772109

Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

A Phase 3 study testing Influenza Virus Vaccine USP Trivalent Types A and B in people with Orthomyxoviridae Infection and Influenza, run by Sanofi Pasteur, a Sanofi Company at 49 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

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route. Primary Objective: To demonstrate lot consistency of the Fluzone ID manufacturing process. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
What is being tested?: Influenza Virus Vaccine USP Trivalent Types A and B
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,292 participants
Where: 49 sitesin 2 countries
Study dates: Oct 2008to Jul 2009
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 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged 18 to 64 years on the day of vaccination.
Informed consent form signed and dated.
Able to attend all scheduled visits and to comply with all trial procedures.
For women of child bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Who cannot join

Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test.
Breast-feeding woman.
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination.
Planned participation in another clinical trial during the present trial period.
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy

Show all 16Show fewer

Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.
Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
Receipt of any vaccination in the 4 weeks preceding the trial vaccination.
Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine.
Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for >=5 years).
Personal or family history of Guillain-Barré Syndrome.

Trial locations and contacts

49 sites in 2 countries.

Country

City, postcode or hospital

49 sites in 2 countries

United States46 sites

Study site
Albuquerque, New Mexico, 87108
Study site
Allentown, Pennsylvania, 18102
Study site
Austin, Texas, 78705
Study site
Bensalem, Pennsylvania, 19020
Study site
Binghamton, New York, 13901
Study site
Boise, Idaho, 83642
Study site
Cary, North Carolina, 27518
Study site
Chandler, Arizona, 85224
Study site
Chicago, Illinois, 60610
Study site
Cincinnati, Ohio, 45249
Study site
Endwell, New York, 13760
Study site
Fort Worth, Texas, 76107
Study site
Fort Worth, Texas, 76135
Study site
Fountain Valley, California, 92708
Study site
Galveston, Texas, 77555
Study site
Hoover, Alabama, 35216
Study site
Huntsville, Alabama, 35802
Study site
Iowa City, Iowa, 52242
Study site
Kansas City, Missouri, 64114
Study site
Lexington, Kentucky, 40509
Study site
Madisonville, Kentucky, 42431
Study site
Marshfield, Wisconsin, 54449
Study site
Melbourne, Florida, 32935
Study site
Mesa, Arizona, 85213
Study site
Milford, Connecticut, 06460
Study site
Mobile, Alabama, 36608
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Nashville, Tennessee, 37203
Study site
Pembroke Pines, Florida, 33024
Study site
Phoenix, Arizona, 85014
Study site
Pinellas Park, Florida, 33781
Study site
Raleigh, North Carolina, 27609
Study site
Rochester, New York, 14609
Study site
Rochester, New York, 14621
Study site
Rockville, Maryland, 20850
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121
Study site
San Angelo, Texas, 76904
Study site
San Diego, California, 92103
Study site
Seattle, Washington, 98101
Study site
Springfield, Missouri, 65802
Study site
St Louis, Missouri, 63104
Study site
Tucson, Arizona, 85711
Study site
Warwick, Rhode Island, 02886
Study site
West Jordan, Utah, 84088
Study site
Wichita, Kansas, 67207

Other trials in United States

Puerto Rico3 sites

Study site
Castellana Gardens, Carolina, 00983
Study site
San Juan, 00918
Study site
San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.

Primary Objective:

To demonstrate lot consistency of the Fluzone ID manufacturing process.
To provide information concerning the immune response of Fluzone ID.

Secondary Objectives:

Safety

To describe the safety profile of subjects who receive of Fluzone ID.

Read the detailed description

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
Being tested: Influenza Virus Vaccine USP Trivalent Types A and B
Keywords: Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Fluzone®, Adults
Medical subject headings: Orthomyxoviridae Infections, Influenza, Human

What participants receive

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

Influenza Virus Vaccine USP Trivalent Types A and BBiological
0.1 mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and BBiological
0.1 mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and BBiological
0.1 mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and BBiological
Also called Fluzone®
0.5 mL, Intramuscular

Study groups in NCT00772109
Study group	Role	What they receive
Fluzone Intradermal Vaccine Lot 1	Experimental	Participants will receive a dose of Influenza intradermal vaccine Lot 1 Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Fluzone Intradermal Vaccine Lot 2	Experimental	Participants will receive a dose of Influenza intradermal vaccine Lot 2 Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Fluzone Intradermal Vaccine Lot 3	Experimental	Participants will receive a dose of Influenza intradermal vaccine Lot 3 Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Fluzone Intramuscular Vaccine	Active comparator	Participants will receive a dose of influenza intramuscular vaccine Receives: Biological: Influenza Virus Vaccine USP Trivalent Types A and B

What is being measured

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

Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
Measured: Baseline (Day 0) and 28 Days post-vaccination
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.
Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.
Measured: 28 Days post-vaccination

Secondary outcomes (2)

Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.
Seroprotection was defined as a HAI antibody titer ≥ 1:40.
Measured: Before and 28 Days post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Measured: Day 0 up to 7 Days post vaccination

Timeline

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

Oct 2008Jul 2009

First posted15 Oct 2008 (estimated)
Study startOct 2008
Primary completionMay 2009
Study completionJul 2009

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 Orthomyxoviridae InfectionStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4,292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00772109
Sponsor's protocol ID: FID31
Status last verified: Apr 2016
First submitted: 13 Oct 2008
Last updated: 14 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gorse GJ, Falsey AR, Fling JA, Poling TL, Strout CB, Tsang PH. Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Vaccine. 2013 May 1;31(19):2358-65. doi: 10.1016/j.vaccine.2013.03.008. Epub 2013 Mar 13.
PubMed 23499604

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years
ClinicalTrials.gov ID: NCT00772109
Acronym / sponsor ID: FID31
Conditions: Orthomyxoviridae Infection, Influenza, Myxovirus Infection
Keywords: Influenza, Orthomyxoviruses, Inactivated Split-virion influenza vaccine, Fluzone®, Adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,292 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: May 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 15 Oct 2008 (estimated)
Results: Posted 10 Aug 2011

Clinical summary

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

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.

Primary Objective:

To demonstrate lot consistency of the Fluzone ID manufacturing process.
To provide information concerning the immune response of Fluzone ID.

Secondary Objectives:

Safety

To describe the safety profile of subjects who receive of Fluzone ID.

Detailed description

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Fluzone Intradermal Vaccine Lot 1	Experimental	Biological: Influenza Virus Vaccine USP Trivalent Types A and BParticipants will receive a dose of Influenza intradermal vaccine Lot 1
Fluzone Intradermal Vaccine Lot 2	Experimental	Biological: Influenza Virus Vaccine USP Trivalent Types A and BParticipants will receive a dose of Influenza intradermal vaccine Lot 2
Fluzone Intradermal Vaccine Lot 3	Experimental	Biological: Influenza Virus Vaccine USP Trivalent Types A and BParticipants will receive a dose of Influenza intradermal vaccine Lot 3
Fluzone Intramuscular Vaccine	Active comparator	Biological: Influenza Virus Vaccine USP Trivalent Types A and BParticipants will receive a dose of influenza intramuscular vaccine

Who may qualify

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

Key inclusion criteria (4 listed)

Aged 18 to 64 years on the day of vaccination.
Informed consent form signed and dated.
Able to attend all scheduled visits and to comply with all trial procedures.
For women of child bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Key exclusion criteria (16 listed)

Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test.
Breast-feeding woman.
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination.
Planned participation in another clinical trial during the present trial period.

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
Influenza Virus Vaccine USP Trivalent Types A and B0.1 mL, Intradermal	Biological	Fluzone Intradermal Vaccine Lot 1
Influenza Virus Vaccine USP Trivalent Types A and B0.1 mL, Intradermal	Biological	Fluzone Intradermal Vaccine Lot 2
Influenza Virus Vaccine USP Trivalent Types A and B0.1 mL, Intradermal	Biological	Fluzone Intradermal Vaccine Lot 3
Influenza Virus Vaccine USP Trivalent Types A and BAlso: Fluzone®0.5 mL, Intramuscular	Biological	Fluzone Intramuscular Vaccine

Primary outcome

Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
Time frame: Baseline (Day 0) and 28 Days post-vaccination
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Time frame: 28 Days post-vaccination
The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.

2 secondary outcomes

Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM
Time frame: Before and 28 Days post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Time frame: Day 0 up to 7 Days post vaccination

Results and safety

Results posted to the registry on 10 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluzone Intradermal (ID) Vaccine Lot 1	956	935
Fluzone Intradermal (ID) Vaccine Lot 2	953	934
Fluzone Intradermal (ID) Vaccine Lot 3	955	936
Fluzone Intramuscular (IM) Vaccine	1,428	1,397

Primary outcome: Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines

Time frame: Baseline (Day 0) and 28 Days post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Fluzone Intradermal (ID) Vaccine Lot 1 n = 863	Fluzone Intradermal (ID) Vaccine Lot 2 n = 856	Fluzone Intradermal (ID) Vaccine Lot 3 n = 860	Fluzone Intramuscular (IM) Vaccine n = 1286
A/H1N1 (Pre-vaccination, N = 863, 856, 860, 1285)	23.50 (21.58 to 25.60)	25.27 (23.16 to 27.58)	25.29 (23.20 to 27.56)	24.84 (23.16 to 26.65)
A/H1N1 (Post-vaccination, N = 863, 855, 861, 1283)	188.56 (172.67 to 205.92)	185.59 (169.81 to 202.83)	206.10 (188.53 to 225.31)	178.30 (166.36 to 191.11)
A/H3N2 (Pre-vaccination, N = 862, 853, 860, 1286)	18.77 (17.29 to 20.38)	20.56 (18.89 to 22.38)	18.37 (16.88 to 19.99)	19.99 (18.65 to 21.43)
A/H3N2 (Post-vaccination, N = 862, 853, 860, 1284)	260.46 (235.49 to 288.09)	234.03 (212.13 to 258.21)	246.06 (222.65 to 271.93)	230.71 (213.75 to 249.03)
B (Pre-vaccination, N = 862, 855, 860, 1286)	23.77 (22.03 to 25.63)	25.59 (23.69 to 27.64)	24.24 (22.51 to 26.10)	25.05 (23.53 to 26.68)
B (Post-vaccination, N = 861, 856, 860, 1285)	103.72 (96.61 to 111.35)	102.91 (95.88 to 110.46)	100.82 (93.95 to 108.20)	126.91 (119.70 to 134.56)

Population analysed: Geometric Mean Titers (GMTs) were analyzed in the per-protocol population

Primary outcome: Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine

Time frame: 28 Days post-vaccination. Number. Unit: Percentage of Participants

Measure	Fluzone Intradermal (ID) Vaccine Lot 1 n = 863	Fluzone Intradermal (ID) Vaccine Lot 2 n = 856	Fluzone Intradermal (ID) Vaccine Lot 3 n = 860	Fluzone Intramuscular (IM) Vaccine n = 1286
A/H1N1 Serogroup	61	59	63	61
A/H3N2 Serogroup	76	73	77	75
B Serogroup	47	45	47	54

Population analysed: Seroprotection was analyzed in the per-protocol population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluzone Intradermal (ID) Vaccine Lot 1	17 of 953 (1.8%)	716 of 953 (75.1%)	Not reported
Fluzone Intradermal (ID) Vaccine Lot 2	16 of 951 (1.7%)	698 of 951 (73.4%)	Not reported
Fluzone Intradermal (ID) Vaccine Lot 3	14 of 951 (1.5%)	726 of 951 (76.3%)	Not reported
Fluzone Intramuscular (IM) Vaccine	20 of 1,421 (1.4%)	749 of 1,421 (52.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23499604Gorse GJ, Falsey AR, Fling JA, Poling TL, Strout CB, Tsang PH. Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Vaccine. 2013 May 1;31(19):2358-65. doi: 10.1016/j.vaccine.2013.03.008. Epub 2013 Mar 13.
Related InfoLink 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.

Medical Monitor study director

Sanofi Pasteur Inc.

49 sites in 2 countries: 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 4 inclusion and 16 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Puerto Rico. 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 10 Aug 2011). 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 Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines (time frame: Baseline (Day 0) and 28 Days post-vaccination). 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 NCT00772109, 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 14 Apr 2016.