PneumoniaPhase 1NCT01446926
Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants
A Phase 1 study testing Pneumococcal Vaccine High Dose (Formulation 1), Pneumococcal Vaccine Low Dose (Formulation 2) and Pneumococcal Vaccine Middle Dose (Formulation 3) in people with Pneumonia and Pneumococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 1 site in Bangladesh.
Trial summary
This study is designed to explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment. Primary Objective: To evaluate the safety and tolerability of an investigational pneumococcal vaccine. Read more about this study
- Who is it for?
- Ages 6 weeks to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal Infections, Streptococcus Pneumoniae Infections
- What is being tested?
- Pneumococcal Vaccine High Dose (Formulation 1), Pneumococcal Vaccine Low Dose (Formulation 2) and Pneumococcal Vaccine Middle Dose (Formulation 3)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteBangladesh
- Study dates
- Sep 2011to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adults:
- Aged 18 to 50 years on the day of inclusion.
- Informed consent form has been signed and dated. If the subject is unable to read the informed consent form, a site-defined standard procedure will be followed to ensure subject understanding of the process and will be marked by the subject and signed by a witness.
- Able to attend all scheduled visits and to comply with all trial procedures.
- Infants and Toddlers:
- Aged 6 to 7 weeks (42 to 49 days) for infants and 12 to 13 months for toddlers on the day of inclusion
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- Born at full term of pregnancy (≥37 weeks) and having a weight ≥ 60% of the median weight for Bangladesh as measured by the "weight-to-length" index.
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations). If the subject's parent(s) or other legally acceptable representative is unable to read the informed consent form, a procedure will be followed to ensure his/her understanding of the process and will be marked by the subject's parent(s) or other legally acceptable representative and signed by a witness.
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- (Adults only): Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).
- Participation or planned participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination except if non-interventional follow-up for an earlier study (e.g., long-term surveillance).
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, or planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- Previous vaccination against S. pneumoniae (in the previous 5 years).
- History of pneumococcal infection (confirmed microbiologically) within 5 years.
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
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- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
- Bleeding disorder, including thrombocytopenia contraindicating intramuscular (IM) vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol abuse or drug addiction.
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- (Adults only): Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
- (Infants and Toddlers only): Parents or guardians identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
- Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Pneumococcal Protein Vaccine (PPrV) in Healthy Adults, Toddlers and Infants in Bangladesh
This study is designed to explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment.
Primary Objective:
- To evaluate the safety and tolerability of an investigational pneumococcal vaccine.
Secondary Objective:
- To evaluate the immunogenicity of an investigational pneumococcal vaccine.
Read the detailed description
All adult participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, toddler participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, infant participants will receive 3 injections of study vaccine or placebo in dose-ascending order (low, medium, and high dose), with a safety evaluation after each dose level before the study proceeds to the next higher dose. All participants will undergo immunogenicity testing and monitoring for safety.
- Being tested
- Pneumococcal Vaccine High Dose (Formulation 1), Tris buffered saline (Placebo), Pneumococcal Vaccine Low Dose (Formulation 2), Pneumococcal Vaccine Middle Dose (Formulation 3), Pneumococcal Vaccine Middle Dose (Formulation 4)
- Keywords
- Pneumonia, Pneumococcal Infections, Streptococcus pneumoniae Infections, Pneumococcal vaccines
- Medical subject headings
- Pneumonia, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal Vaccine High Dose (Formulation 1)Biological
0.5 mL, Intramuscular
Tris buffered saline (Placebo)Biological
Also called Tris buffered saline
0.5 mL, Intramuscular
Pneumococcal Vaccine High Dose (Formulation 1)Biological
0.5 mL, Intramuscular
Tris buffered saline (Placebo)Biological
Also called Tris buffered saline
0.5 mL, Intramuscular
Pneumococcal Vaccine Low Dose (Formulation 2)Biological
0.5 mL, Intramuscular
Tris buffered saline (Placebo)Biological
Also called Tris buffered saline
0.5 mL, Intramuscular
Pneumococcal Vaccine Middle Dose (Formulation 3)Biological
0.5 mL, Intramuscular
Pneumococcal Vaccine Middle Dose (Formulation 4)Biological
0.5 mL, Intramuscular
Tris buffered saline (Placebo)Biological
Also called Tris buffered saline
0.5 mL, Intramuscular
Pneumococcal Vaccine High Dose (Formulation 1)Biological
0.5 mL, Intramuscular
Tris buffered saline (Placebo)Biological
Also called Tris buffered saline
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Adults High Dose (Formulation 1) | Experimental | Adults who will receive a single injection of high dose investigational Pneumococcal vaccine Receives: Biological: Pneumococcal Vaccine High Dose (Formulation 1) |
| Group 2: Adults Placebo | Placebo comparator | Adult participants who will receive an injection of placebo Receives: Biological: Tris buffered saline (Placebo) |
| Group 3: Toddlers High Dose (Formulation 1) | Experimental | Toddlers who will receive a single injection of high dose Pneumococcal vaccine Receives: Biological: Pneumococcal Vaccine High Dose (Formulation 1) |
| Group 4: Toddlers Placebo | Placebo comparator | Toddlers who will receive a single injection of placebo Receives: Biological: Tris buffered saline (Placebo) |
| Group 5: Infants Low Dose (Formulation 2) | Experimental | Infants who will receive 3 injections of low dose low dose Pneumococcal vaccine Receives: Biological: Pneumococcal Vaccine Low Dose (Formulation 2) |
| Group 6: Infants Placebo | Placebo comparator | Infants who will receive 3 injections of placebo Receives: Biological: Tris buffered saline (Placebo) |
| Group 7: Infants Middle Dose (Formulation 3) | Experimental | Infants who will receive 3 injections of middle dose Pneumococcal vaccine Receives: Biological: Pneumococcal Vaccine Middle Dose (Formulation 3) |
| Group 8: Infants Middle Dose (Formulation 4) | Experimental | Infants who will receive 3 injections of middle dose Pneumococcal vaccine Receives: Biological: Pneumococcal Vaccine Middle Dose (Formulation 4) |
| Group 9: Infants Placebo | Placebo comparator | Infants who will receive 3 injections of placebo Receives: Biological: Tris buffered saline (Placebo) |
| Group 10: Infants High Dose (Formulation 1) | Experimental | Infants who will receive 3 injections of high dose Pneumococcal vaccine Receives: Biological: Pneumococcal Vaccine High Dose (Formulation 1) |
| Group 11: Infants Placebo | Placebo comparator | Infants who will receive 3 injections of placebo Receives: Biological: Tris buffered saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants reporting solicited injection site and systemic reactions, unsolicited systemic reactions, and serious adverse events following vaccination.
Solicited injection site reactions: For adults: Pain, Erythema, and Swelling; Toddlers and infants: Tenderness, Erythema, Swelling. Solicited systemic reactions: For adults, Fever (Temperature), Headache, Malaise, and Myalgia; Toddlers and infants, Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.
Measured: Day 0 through Day 90 post-vaccination
Secondary outcomes (2)
Immunogenicity of the Pneumococcal Vaccine in adults and toddlers
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Measured: Day 30 post-vaccination (adults and toddlers)
Immunogenicity of the Pneumococcal Vaccine in toddlers
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Measured: Day 30 post-vaccination 2 and 3 (infants)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446926
- Sponsor's protocol ID
- PPR02
- Other IDs
- U1111-1117-7316
- Status last verified
- Jan 2018
- First submitted
- 3 Oct 2011
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brooks WA, Chang LJ, Sheng X, Hopfer R; PPR02 Study Team. Safety and immunogenicity of a trivalent recombinant PcpA, PhtD, and PlyD1 pneumococcal protein vaccine in adults, toddlers, and infants: A phase I randomized controlled study. Vaccine. 2015 Aug 26;33(36):4610-7. doi: 10.1016/j.vaccine.2015.06.078. Epub 2015 Jul 2.
PubMed 26143615
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Pneumococcal Protein Vaccine (PPrV) in Healthy Adults, Toddlers and Infants in Bangladesh
- ClinicalTrials.gov ID
- NCT01446926
- Acronym / sponsor ID
- PPR02
- Keywords
- Pneumonia, Pneumococcal Infections, Streptococcus pneumoniae Infections, Pneumococcal vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
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 explore the safety and tolerability of an investigational pneumococcal vaccine through a step-down enrollment.
Primary Objective:
- To evaluate the safety and tolerability of an investigational pneumococcal vaccine.
Secondary Objective:
- To evaluate the immunogenicity of an investigational pneumococcal vaccine.
Detailed description
All adult participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, toddler participants will receive a single injection of study vaccine or placebo. After satisfactory safety evaluation, infant participants will receive 3 injections of study vaccine or placebo in dose-ascending order (low, medium, and high dose), with a safety evaluation after each dose level before the study proceeds to the next higher dose. All participants will undergo immunogenicity testing and monitoring for safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Group 1: Adults High Dose (Formulation 1) | Experimental | Biological: Pneumococcal Vaccine High Dose (Formulation 1)Adults who will receive a single injection of high dose investigational Pneumococcal vaccine |
| Group 2: Adults Placebo | Placebo comparator | Biological: Tris buffered saline (Placebo)Adult participants who will receive an injection of placebo |
| Group 3: Toddlers High Dose (Formulation 1) | Experimental | Biological: Pneumococcal Vaccine High Dose (Formulation 1)Toddlers who will receive a single injection of high dose Pneumococcal vaccine |
| Group 4: Toddlers Placebo | Placebo comparator | Biological: Tris buffered saline (Placebo)Toddlers who will receive a single injection of placebo |
| Group 5: Infants Low Dose (Formulation 2) | Experimental | Biological: Pneumococcal Vaccine Low Dose (Formulation 2)Infants who will receive 3 injections of low dose low dose Pneumococcal vaccine |
| Group 6: Infants Placebo | Placebo comparator | Biological: Tris buffered saline (Placebo)Infants who will receive 3 injections of placebo |
| Group 7: Infants Middle Dose (Formulation 3) | Experimental | Biological: Pneumococcal Vaccine Middle Dose (Formulation 3)Infants who will receive 3 injections of middle dose Pneumococcal vaccine |
| Group 8: Infants Middle Dose (Formulation 4) | Experimental | Biological: Pneumococcal Vaccine Middle Dose (Formulation 4)Infants who will receive 3 injections of middle dose Pneumococcal vaccine |
| Group 9: Infants Placebo | Placebo comparator | Biological: Tris buffered saline (Placebo)Infants who will receive 3 injections of placebo |
| Group 10: Infants High Dose (Formulation 1) | Experimental | Biological: Pneumococcal Vaccine High Dose (Formulation 1)Infants who will receive 3 injections of high dose Pneumococcal vaccine |
| Group 11: Infants Placebo | Placebo comparator | Biological: Tris buffered saline (Placebo)Infants who will receive 3 injections of placebo |
Who may qualify
- Ages
- 6 weeks to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Aged 18 to 50 years on the day of inclusion.
- Informed consent form has been signed and dated. If the subject is unable to read the informed consent form, a site-defined standard procedure will be followed to ensure subject understanding of the process and will be marked by the subject and signed by a witness.
- Able to attend all scheduled visits and to comply with all trial procedures.
- Aged 6 to 7 weeks (42 to 49 days) for infants and 12 to 13 months for toddlers on the day of inclusion
- Born at full term of pregnancy (≥37 weeks) and having a weight ≥ 60% of the median weight for Bangladesh as measured by the "weight-to-length" index.
Key exclusion criteria (16 listed)
- (Adults only): Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).
- Participation or planned participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination except if non-interventional follow-up for an earlier study (e.g., long-term surveillance).
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, or planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- Previous vaccination against S. pneumoniae (in the previous 5 years).
- History of pneumococcal infection (confirmed microbiologically) within 5 years.
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 |
|---|---|---|
| Pneumococcal Vaccine High Dose (Formulation 1)0.5 mL, Intramuscular | Biological | Group 1: Adults High Dose (Formulation 1) |
| Tris buffered saline (Placebo)Also: Tris buffered saline0.5 mL, Intramuscular | Biological | Group 2: Adults Placebo |
| Pneumococcal Vaccine High Dose (Formulation 1)0.5 mL, Intramuscular | Biological | Group 3: Toddlers High Dose (Formulation 1) |
| Tris buffered saline (Placebo)Also: Tris buffered saline0.5 mL, Intramuscular | Biological | Group 4: Toddlers Placebo |
| Pneumococcal Vaccine Low Dose (Formulation 2)0.5 mL, Intramuscular | Biological | Group 5: Infants Low Dose (Formulation 2) |
| Tris buffered saline (Placebo)Also: Tris buffered saline0.5 mL, Intramuscular | Biological | Group 6: Infants Placebo |
| Pneumococcal Vaccine Middle Dose (Formulation 3)0.5 mL, Intramuscular | Biological | Group 7: Infants Middle Dose (Formulation 3) |
| Pneumococcal Vaccine Middle Dose (Formulation 4)0.5 mL, Intramuscular | Biological | Group 8: Infants Middle Dose (Formulation 4) |
| Tris buffered saline (Placebo)Also: Tris buffered saline0.5 mL, Intramuscular | Biological | Group 9: Infants Placebo |
| Pneumococcal Vaccine High Dose (Formulation 1)0.5 mL, Intramuscular | Biological | Group 10: Infants High Dose (Formulation 1) |
| Tris buffered saline (Placebo)Also: Tris buffered saline0.5 mL, Intramuscular | Biological | Group 11: Infants Placebo |
Primary outcome
Number and percentage of participants reporting solicited injection site and systemic reactions, unsolicited systemic reactions, and serious adverse events following vaccination.
Time frame: Day 0 through Day 90 post-vaccination
Solicited injection site reactions: For adults: Pain, Erythema, and Swelling; Toddlers and infants: Tenderness, Erythema, Swelling. Solicited systemic reactions: For adults, Fever (Temperature), Headache, Malaise, and Myalgia; Toddlers and infants, Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.
2 secondary outcomes
Immunogenicity of the Pneumococcal Vaccine in adults and toddlers
Time frame: Day 30 post-vaccination (adults and toddlers)
Immunogenicity of the Pneumococcal Vaccine in toddlers
Time frame: Day 30 post-vaccination 2 and 3 (infants)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Results publication: PubMed 26143615Brooks WA, Chang LJ, Sheng X, Hopfer R; PPR02 Study Team. Safety and immunogenicity of a trivalent recombinant PcpA, PhtD, and PlyD1 pneumococcal protein vaccine in adults, toddlers, and infants: A phase I randomized controlled study. Vaccine. 2015 Aug 26;33(36):4610-7. doi: 10.1016/j.vaccine.2015.06.078. Epub 2015 Jul 2.
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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 Director study director
Sanofi Pasteur Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pneumococcal Vaccine High Dose (Formulation 1), Pneumococcal Vaccine Low Dose (Formulation 2) and Pneumococcal Vaccine Middle Dose (Formulation 3) in people with Pneumonia and Pneumococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 1 site in Bangladesh.
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 9 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and percentage of participants reporting solicited injection site and systemic reactions, unsolicited systemic reactions, and serious adverse events following vaccination. (time frame: Day 0 through Day 90 post-vaccination). 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 NCT01446926, 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 10 Jan 2018.