Meningococcal DiseasePhase 3NCT01214837

Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

A Phase 3 study testing MenACWY-CRM and Routine Vaccines in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 40 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 was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series. Read more about this study

Who is it for?: Ages 55 to 89 daysHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease, Meningococcal Meningitis
What is being tested?: MenACWY-CRM and Routine Vaccines
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 751 participants
Where: 40 sitesin 2 countries
Study dates: Oct 2010to May 2012
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 55 to 89 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.

Who cannot join

Serious, acute, or chronic illnesses are reasons for exclusion.

Trial locations and contacts

40 sites in 2 countries.

Country

City, postcode or hospital

40 sites in 2 countries

United States37 sites

Study site
Bardstown, Kentucky
Study site
Binghamton, New York
Study site
Birmingham, Alabama
Study site
Dayton, Ohio
Study site
Fayetteville, Arkansas
Study site
Fountain Valley, California
Study site
Haughton, Louisiana
Study site
Huber Heights, Ohio
Study site
Huntington Beach, California
Study site
Johnson City, New York
Study site
Jonesboro, Arkansas
Study site
Kettering, Ohio
Study site
Kingsport, Tennessee
Study site
Layton, Utah
Study site
Lebanon, Tennessee
Study site
Lincoln, Nebraska
Study site
Little Rock, Arkansas
Bluegrass Clinical Research (Bardstown Road)
Louisville, Kentucky
Bluegrass Clinical Research (Brownsboro Park Blvd)
Louisville, Kentucky
Study site
Madera, California
Study site
Nampa, Idaho
Study site
Niles, Michigan
Children's Physicians Dundee
Omaha, Nebraska
Creighton Univ
Omaha, Nebraska
Study site
Richmond, Virginia
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Shreveport, Louisiana
Rockwood Clinic P S
Spokane, Washington, 99202
Rockwood Clinic P S
Spokane, Washington, 99218
Study site
Springfield, Kentucky
Study site
St. George, Utah
Study site
Syracuse, New York
Study site
Tomball, Texas
Cotton ONeil Clinical Research
Topeka, Kansas, 66604
Cotton ONeil Clinical Research
Topeka, Kansas, 66614
Study site
Tulsa, Oklahoma

Other trials in United States

Canada3 sites

Study site
Greater Sudbury, Ontario
Study site
Pierrefonds, Quebec
Study site
Toronto, Ontario

Other trials in Canada

About this study

Official title: A Phase 3b, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life.

The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.

Conditions: Meningococcal Disease, Meningococcal Meningitis
Being tested: MenACWY-CRM, Routine Vaccines
Keywords: Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Infants, Persistence
Medical subject headings: Meningococcal Infections, Meningitis, Meningococcal, Meningitis

What participants receive

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

MenACWY-CRMBiological
This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
MenACWY-CRMBiological
This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
Routine VaccinesBiological
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

Study groups in NCT01214837
Study group	Role	What they receive
MenACWY3	Experimental	Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age. Receives: Biological: MenACWY-CRM; Biological: Routine Vaccines
MenACWY4	Experimental	All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4. Receives: Biological: MenACWY-CRM; Biological: Routine Vaccines
Routine Vaccines	Placebo comparator	Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Receives: Biological: Routine Vaccines

What is being measured

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

Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.
Measured: 13 months of age
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.
Measured: 13 months of age

Secondary outcomes (11)

Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.
Measured: Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Measured: Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.
Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.
Measured: 12 months of age.
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.
The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.
Measured: 12 months of age
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.
Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.
Measured: 13 months of age
Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.
The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.
Measured: 13 months of age
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.
Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.
Measured: 7 months of age.
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.
Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.
Measured: 13 months of age.
Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.
Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.
Measured: Within 7 days
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.
Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.
Measured: Day 1 through Day 7
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Measured: 13 months of age

Timeline

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

Oct 2010May 2012

First posted5 Oct 2010 (estimated)
Study startOct 2010
Primary completionApr 2012
Study completionMay 2012

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 Meningococcal DiseaseStudies of the same condition, open and under way.
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: None (open label)
Enrolment: 751 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01214837
Sponsor's protocol ID: V59_36
Status last verified: Sep 2018
First submitted: 27 Sep 2010
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Block SL, Shepard J, Garfield H, Xie F, Han L, Dull PM, Smolenov I. Immunogenicity and Safety of a 3- and 4-dose Vaccination Series of a Meningococcal ACWY Conjugate Vaccine in Infants: Results of a Phase 3b, Randomized, Open-label Trial. Pediatr Infect Dis J. 2016 Feb;35(2):e48-59. doi: 10.1097/INF.0000000000000965.
PubMed 26479973

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 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life.
ClinicalTrials.gov ID: NCT01214837
Acronym / sponsor ID: V59_36
Conditions: Meningococcal Disease, Meningococcal Meningitis
Keywords: Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Infants, Persistence
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 751 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Apr 2012 (actual)
Study completion: May 2012 (actual)
First posted: 5 Oct 2010 (estimated)
Results: Posted 2 Oct 2014

Clinical summary

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

The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
MenACWY3	Experimental	Biological: MenACWY-CRM, Biological: Routine VaccinesSubjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
MenACWY4	Experimental	Biological: MenACWY-CRM, Biological: Routine VaccinesAll the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
Routine Vaccines	Placebo comparator	Biological: Routine VaccinesSubjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.

Who may qualify

Ages: 55 to 89 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.

Key exclusion criteria (1 listed)

Serious, acute, or chronic illnesses are reasons for exclusion.

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
MenACWY-CRMThis group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.	Biological	MenACWY4
MenACWY-CRMThis group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.	Biological	MenACWY3
Routine VaccinesEach 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.	Biological	MenACWY3, MenACWY4, Routine Vaccines

Primary outcome

Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.
Time frame: 13 months of age
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.
Time frame: 13 months of age
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.

11 secondary outcomes

Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Time frame: Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Time frame: Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.
Time frame: 12 months of age.
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.
Time frame: 12 months of age
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.
Time frame: 13 months of age
Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.
Time frame: 13 months of age
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.
Time frame: 7 months of age.
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.
Time frame: 13 months of age.
Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.
Time frame: Within 7 days
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.
Time frame: Day 1 through Day 7
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Time frame: 13 months of age

Results and safety

Results posted to the registry on 2 Oct 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
MenACWY3	249	195
MenACWY4	256	192
Routine Vaccines	246	184

Primary outcome: Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.

Time frame: 13 months of age. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	MenACWY4 n = 152
Serogroup A (N=141)	96 (91 to 98)
Serogroup C	99 (95 to 100)
Serogroup W (N=138)	99 (96 to 100)
Serogroup Y (N=146)	99 (96 to 100)

Population analysed: Analysis was done on the Toddler Per Protocol Population (PPS) - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding through 13 month timepoint.

Primary outcome: Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.

Time frame: 13 months of age. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	MenACWY3 n = 160	MenACWY4 n = 152
Serogroup A (N=146,141)	88 (82 to 93)	96 (91 to 98)
Serogroup C	95 (90 to 98)	99 (95 to 100)
Serogroup W (N=153,138)	99 (96 to 100)	99 (96 to 100)
Serogroup Y (N=154,146)	100 (98 to 100)	99 (96 to 100)

MenACWY3 vs MenACWY4: Vaccine group difference: -7 (95% CI -14 to -1), Miettinen and Nurminen method
MenACWY3 vs MenACWY4: Vaccine group difference: -4 (95% CI -8 to 0), Miettinen and Nurminen method
MenACWY3 vs MenACWY4: Vaccine group difference: 0 (95% CI -3 to 3), Miettinen and Nurminen method

Population analysed: Analysis was done on Toddler PPS.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 13 months of age. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY3	11 of 242 (4.5%)	238 of 242 (98.3%)	Not reported
MenACWY4	19 of 252 (7.5%)	233 of 252 (92.5%)	Not reported
Routine Vaccines	11 of 239 (4.6%)	228 of 239 (95.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26479973Block SL, Shepard J, Garfield H, Xie F, Han L, Dull PM, Smolenov I. Immunogenicity and Safety of a 3- and 4-dose Vaccination Series of a Meningococcal ACWY Conjugate Vaccine in Infants: Results of a Phase 3b, Randomized, Open-label Trial. Pediatr Infect Dis J. 2016 Feb;35(2):e48-59. doi: 10.1097/INF.0000000000000965.

Related trials for Meningococcal Disease

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RecruitingPhase 3
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenACWY-CRM and Routine Vaccines in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 40 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 1 inclusion and 1 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 Oct 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, 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. Some participants in this study may receive a placebo. 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 2 Oct 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?

Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. (time frame: 13 months of age). 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 NCT01214837, 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 9 Oct 2018.