Serogroup C Meningococcal MeningitisPhase 2/3NCT02858570
Conjugate Vaccine Against Meningococcus C a Brazilian Project
A Phase 2/3 study testing MenCC-BIO Vaccine and Combined - CRM197 in people with Serogroup C Meningococcal Meningitis, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
Trial summary
TYPE / DESIGN STUDY: Clinical trial phase II / III, randomized, double-blind, national multi-center, with a total of 1,644 research participants stratified into 3 groups according to age for starting of the primary vaccination schedule (Stratum I - 11 to 19 years, Stratum II - 1 to 10 years; Stratum III - less than 1… Read more about this study
- Who is it for?
- Ages 3 months to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Serogroup C Meningococcal Meningitis
- What is being tested?
- MenCC-BIO Vaccine and Combined - CRM197
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,644 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Sep 2018to Apr 2020
- Phase
- Phase 2/3
- 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 3 months to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be current on the national calendar own vaccination for the age group (except for meningitis C vaccine - see exclusion criteria).
- Available for monitoring throughout the study period.
- Willing to provide name, address, telephone number and other information so that we can contact the person if necessary (eg in case of missing the scheduled visit).
- Willing to strictly follow the study protocol.
- Legal Responsible and research participants with the ability to understand and sign the free and informed consent and the informed free consent term, according to the particularities of the age groups.
- Understand the impossibility to participate in another clinical trial during the time you are participating in the study.
- intellectual level or that of his legal guardian (if applicable according to age research participant) for the filling in the forms for registration of signs and symptoms at home.
Who cannot join
- Previous vaccination against meningococcus
- Personal history of meningitis of any kind.
- Personal history of anaphylaxis, asthma, urticaria or other hypersensitivity reaction to previous vaccinations or who have allergies or hypersensitivity to the study vaccine components.
- Use of allergy shots with antigens within 14 days or less prior to vaccination.
- Immunoglobulin Use in the last 12 months prior to vaccination.
- Use of blood products in the 12 months prior to vaccination.
Show all 23Show fewer
- Use of any type of vaccine within 30 days before study vaccination.
- The use of injectable vaccines least 30 days after the vaccination study.
- Chronic use of any medication, except homeopathic medicines, medication trivial as saline nasal use and vitamins, and birth control.
- Prior use of immunosuppressant or cytotoxic medication. individuals are acceptable to have made use of this type of medication not immunosuppressant doses for over 6 months as nasal steroids for allergic rhinitis or topical steroids for uncomplicated dermatitis.
- In use of systemic treatment with high doses of steroids (for example, 1 mg / kg / day of prednisone for at least 14 days, or equivalent) or history of chronic use of high power inhaled corticosteroids (e.g., 800 ug per fluticasone day).
- Use of any type of medication in clinical trials over a period of one year prior to vaccination.
- Personal history of neurological, cardiovascular, respiratory, hepatic, renal, hematologic, rheumatic or autoimmune clinically significant (diseases that have led to hospitalization or prolonged treatment).
- Personal history of bleeding disorders diagnosed by a physician or account of capillary fragility (eg. Bruising or bleeding without justifiable cause).
- Personal history of seizures.
- personal history of psychiatric disease that hinders adherence to protocol, such as psychosis, obsessive-compulsive neuroses, bipolar disorder being treated, diseases that require treatment with lithium and suicidal ideas in the past 5 years prior to enrollment.
- Personal history of active malignant disease (eg any type of cancer) or treated you can use during the study.
- Personal history of sickle cell anemia.
- Asplenia (absence of spleen or removal thereof).
- HIV positive or history of any immunosuppressive disease.
- Pregnancy or breastfeeding. Additional criteria for female participants of childbearing age: negative pregnancy test prior to application of doses of vaccines.
- The presence of any disorder that, in the opinion of the principal investigator, may interfere with the evaluation of the study objectives.
- Inability to collect blood for evaluation of pre-vaccine based (baseline).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
• Unidade de Ensaios Clínicos para Imunobiológicos/Instituto de Tecnologia em Imunobiológicos de Bio-Manguinhos/Fiocruz
Rio de Janeiro, 21040900
Tatiana GU Noronha, PI, 552138829479, Tnoronha@bio.fiocruz.br
Carla RF Trevia, SN, 552138659630 ext. 9645, carla.trevia@bio.fiocruz.br
About this study
Official title: Immunogenicity, Reactogenicity and Safety Assessment of the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos / FIOCRUZ in Infants, Children and Adolescents
TYPE / DESIGN STUDY: Clinical trial phase II / III, randomized, double-blind, national multi-center, with a total of 1,644 research participants stratified into 3 groups according to age for starting of the primary vaccination schedule (Stratum I - 11 to 19 years, Stratum II - 1 to 10 years; Stratum III - less than 1 year old).
BACKGROUND / STUDY CASE: Clinical trial phase II / III, which purpose is to evaluate immunogenicity, safety and reactogenicity of the vaccine against meningococcus C, conjugated to tetanus toxoid, developed by Bio-Manguinhos / FIOCRUZ (MenCC-Bio). The hypothesis of the study is that MenCC-BIO vaccine is safe and not inferior in terms of immunogenicity to the comparator vaccine currently available for the National Immunization Program in the child's immunization schedule. Thus, MenCC-Bio vaccine may meet the need for expansion of the target age group of vaccination in routine public health services and will be available to the National Immunization Program as a strategy to ensure sustainability and self-sufficiency to vaccination policy.
Read more
OBJECTIVES PRIMARY: To assess the immunogenicity of MenCC Bio-vaccine in patients from 3 months to 19 years of age, in relation to the vaccine against meningococcus C currently provided by the National Immunization Program. To evaluate the safety and reactogenicity of MenCC Bio-vaccine in patients from 3 months to 19 years old.
SECONDARY OBJECTIVES: Evaluate the cellular immune component to meningococcal C conjugate vaccine in a subset of survey participants, aged 11 to 19 years.
STUDY POPULATION: Individuals of both sexes, healthy, aged between 3 months and 19 years, attending the campus of Fiocruz / Rio de Janeiro, or municipal health units in Rio de Janeiro (living in areas covered by the municipal units health participants) that fit in the study eligibility criteria.
NUMBER OF CENTRES: Two Clinical sites.
STUDY DURATION: Estimate of 19 months.
INTERVENTION / TREATMENT: Two intervention groups (MenCC-BIO Vaccine and Comparator) in three age groups, with specific vaccination schedules. For the age groups I and II are applied 2 doses ideal interval of 6 months between them. In stratum III, are recommended 3 doses of the vaccine, at ages 3, 5 and 12 months of age, according to calendar of the National Immunization Program.
OUTCOMES PRIMARY:
Immunogenicity:
Proportion of seroconversion defined by the seronegative status change (titles of bactericidal antibodies in children rabbit complement than 1: 8) to seropositive (titers of bactericidal antibodies in larger rabbit complement or equal to 1: 8) or increase 4 times of post vaccinal compared to pre-vacianais after the full vaccination schedule by age stratum.
Geometric mean antibody titers (TGM) pre- and post-vaccination, for each vaccine group, and the ratio of these securities after the full vaccination schedule by age stratum.
Safety and reactogenicity: Frequency and intensity of adverse events solicited and unsolicited, which occurred 30 days after vaccination.
SECONDARY OUTCOME : cell detection B (CD19 +) memory phenotype (CD27 + IgD +, CD27 + IgD) in a subgroup of patients in the age stratum I (11-19 years old). ADDITIONAL INFORMATION age escalation, with interim analysis of inter-layer security and approval by the Security Independent Monitoring Committee of progression to the next lower age stratum.
Read the detailed description
Status: Not yet recruiting: participants are not yet being recruited.
- Conditions
- Serogroup C Meningococcal Meningitis
- Being tested
- MenCC-BIO Vaccine, Combined - CRM197
- Keywords
- Meningococcal Vaccines, Immunogenicity, Reactogenicity and Safety of Vaccine
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenCC-BIO VaccineBiological
The Bio-MenCC vaccine is composed of serogroup C meningococcal polysaccharide conjugated to tetanus toxoid as the carrier protein, with 10 microgram of capsular polysaccharide of group C, 10-20 microgram of tetanus toxoid per dose and aluminum hydroxide at a concentration of 1 milligram dose (0.35 milligram Al3 +) with phosphate buffered saline as diluent. The vaccine is lyophilized and must be reconstituted with diluent and homogenized at the time of application. The lyophilised vaccine is presented as a white powder and the sterile diluent is translucent. Both are presented in vial of colorless neutral glass.
Combined - CRM197Biological
The comparison is against meningococcal C vaccine produced by the Foundation Ezequiel Dias (FUNED), licensed by ANVISA and currently provided by the National Immunization Program in the child's immunization schedule. This vaccine containing 10 microgram of meningococcal C oligosaccharide conjugate 12,5-25microgram of CRM197 protein of Corynebacterium diphtheriae, and presents aluminum hydroxide (0.3 to 0.4 milligram Al3 +) in its formulation. It is also a lyophilized product must be reconstituted and homogenized before use. The meningococcal C vaccine adsorbed (combined - CRM197) comprises two frascos- ampoule, containing a white or off-white lyophilized powder and another vial containing a white opalescent suspension (diluent).
| Study group | Role | What they receive |
|---|---|---|
| MenCC-BIO Vaccine | Experimental | Vaccine against meningococcus serogroup C conjugated to tetanus toxoid produced by Bio-Manguinhos / FIOCRUZ (MenCC-Bio). Stratum I - 11-19 years; Stratum II - 1 to 10; Stratum III - less than 1 year old)For the age groups I and II are applied 2 doses ideal interval of 6 months between them. In stratum III, are recommended 3 doses of the vaccine, at ages 3, 5 and 12 months of age, according to calendar of the National Immunization Program. Receives: Biological: MenCC-BIO Vaccine |
| combined - CRM197 | Active comparator | Adsorbed vaccine meningococcal C (combined - CRM197) produced by the Foundation Ezequiel Dias (FUNED). Stratum I - 11-19 years; Stratum II - 1 to 10; Stratum III - less than 1 year old). For the age groups I and II are applied 2 doses ideal interval of 6 months between them. In stratum III, are recommended 3 doses of the vaccine, at ages 3, 5 and 12 months of age, according to calendar of the National Immunization Program. Receives: Biological: Combined - CRM197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure seroconversion proportion
Measured: Immediately before administration of the booster dose
Measure geometric mean antibody titers (TGM)
Measured: Immediately before administration of the booster dose
Measure frequency and intensity of adverse events solicited and unsolicited
Measured: 30 days after vaccination
Measure seroconversion proportion
Measured: 30 days after administration of the booster dose
Measure the ratio of antibody titers
Measured: 30 days after administration of the booster dose
Measure the ratio antibody titers
Measured: Immediately before administration of the booster dose
Measure geometric mean antibody titers (TGM)
Measured: 30 days after administration of the booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start25 Sep 2018
- Primary completionMay 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serogroup C Meningococcal MeningitisStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,644 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatiana de Noronha, Doc, Principal investigator, The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858570
- Sponsor's protocol ID
- ASCLIN 001/2016
- Status last verified
- Oct 2018
- First submitted
- 26 Jul 2016
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity, Reactogenicity and Safety Assessment of the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos / FIOCRUZ in Infants, Children and Adolescents
- ClinicalTrials.gov ID
- NCT02858570
- Acronym / sponsor ID
- ASCLIN 001/2016
- Conditions
- Serogroup C Meningococcal Meningitis
- Keywords
- Meningococcal Vaccines, Immunogenicity, Reactogenicity and Safety of Vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,644 participants (estimated)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 8 Aug 2016 (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.
TYPE / DESIGN STUDY: Clinical trial phase II / III, randomized, double-blind, national multi-center, with a total of 1,644 research participants stratified into 3 groups according to age for starting of the primary vaccination schedule (Stratum I - 11 to 19 years, Stratum II - 1 to 10 years; Stratum III - less than 1 year old).
BACKGROUND / STUDY CASE: Clinical trial phase II / III, which purpose is to evaluate immunogenicity, safety and reactogenicity of the vaccine against meningococcus C, conjugated to tetanus toxoid, developed by Bio-Manguinhos / FIOCRUZ (MenCC-Bio). The hypothesis of the study is that MenCC-BIO vaccine is safe and not inferior in terms of immunogenicity to the comparator vaccine currently available for the National Immunization Program in the child's immunization schedule. Thus, MenCC-Bio vaccine may meet the need for expansion of the target age group of vaccination in routine public health services and will be available to the National Immunization Program as a strategy to ensure sustainability and self-sufficiency to vaccination policy.
OBJECTIVES PRIMARY: To assess the immunogenicity of MenCC Bio-vaccine in patients from 3 months to 19 years of age, in relation to the vaccine against meningococcus C currently provided by the National Immunization Program. To evaluate the safety and reactogenicity of MenCC Bio-vaccine in patients from 3 months to 19 years old.
SECONDARY OBJECTIVES: Evaluate the cellular immune component to meningococcal C conjugate vaccine in a subset of survey participants, aged 11 to 19 years.
STUDY POPULATION: Individuals of both sexes, healthy, aged between 3 months and 19 years, attending the campus of Fiocruz / Rio de Janeiro, or municipal health units in Rio de Janeiro (living in areas covered by the municipal units health participants) that fit in the study eligibility criteria.
NUMBER OF CENTRES: Two Clinical sites.
STUDY DURATION: Estimate of 19 months.
INTERVENTION / TREATMENT: Two intervention groups (MenCC-BIO Vaccine and Comparator) in three age groups, with specific vaccination schedules. For the age groups I and II are applied 2 doses ideal interval of 6 months between them. In stratum III, are recommended 3 doses of the vaccine, at ages 3, 5 and 12 months of age, according to calendar of the National Immunization Program.
OUTCOMES PRIMARY:
Immunogenicity:
Proportion of seroconversion defined by the seronegative status change (titles of bactericidal antibodies in children rabbit complement than 1: 8) to seropositive (titers of bactericidal antibodies in larger rabbit complement or equal to 1: 8) or increase 4 times of post vaccinal compared to pre-vacianais after the full vaccination schedule by age stratum.
Geometric mean antibody titers (TGM) pre- and post-vaccination, for each vaccine group, and the ratio of these securities after the full vaccination schedule by age stratum.
Safety and reactogenicity: Frequency and intensity of adverse events solicited and unsolicited, which occurred 30 days after vaccination.
SECONDARY OUTCOME : cell detection B (CD19 +) memory phenotype (CD27 + IgD +, CD27 + IgD) in a subgroup of patients in the age stratum I (11-19 years old). ADDITIONAL INFORMATION age escalation, with interim analysis of inter-layer security and approval by the Security Independent Monitoring Committee of progression to the next lower age stratum.
Detailed description
Status: Not yet recruiting: participants are not yet being recruited.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MenCC-BIO Vaccine | Experimental | Biological: MenCC-BIO VaccineVaccine against meningococcus serogroup C conjugated to tetanus toxoid produced by Bio-Manguinhos / FIOCRUZ (MenCC-Bio). Stratum I - 11-19 years; Stratum II - 1 to 10; Stratum III - less than 1 year old)For the age groups I and II are applied 2 doses ideal interval of 6 months between them. In stratum III, are recommended 3 doses of the vaccine, at ages 3, 5 and 12 months of age, according to calendar of the National Immunization Program. |
| combined - CRM197 | Active comparator | Biological: Combined - CRM197Adsorbed vaccine meningococcal C (combined - CRM197) produced by the Foundation Ezequiel Dias (FUNED). Stratum I - 11-19 years; Stratum II - 1 to 10; Stratum III - less than 1 year old). For the age groups I and II are applied 2 doses ideal interval of 6 months between them. In stratum III, are recommended 3 doses of the vaccine, at ages 3, 5 and 12 months of age, according to calendar of the National Immunization Program. |
Who may qualify
- Ages
- 3 months to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Be current on the national calendar own vaccination for the age group (except for meningitis C vaccine - see exclusion criteria).
- Available for monitoring throughout the study period.
- Willing to provide name, address, telephone number and other information so that we can contact the person if necessary (eg in case of missing the scheduled visit).
- Willing to strictly follow the study protocol.
- Legal Responsible and research participants with the ability to understand and sign the free and informed consent and the informed free consent term, according to the particularities of the age groups.
Key exclusion criteria (23 listed)
- Previous vaccination against meningococcus
- Personal history of meningitis of any kind.
- Personal history of anaphylaxis, asthma, urticaria or other hypersensitivity reaction to previous vaccinations or who have allergies or hypersensitivity to the study vaccine components.
- Use of allergy shots with antigens within 14 days or less prior to vaccination.
- Immunoglobulin Use in the last 12 months prior to vaccination.
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 |
|---|---|---|
| MenCC-BIO VaccineThe Bio-MenCC vaccine is composed of serogroup C meningococcal polysaccharide conjugated to tetanus toxoid as the carrier protein, with 10 microgram of capsular polysaccharide of group C, 10-20 microgram of tetanus toxoid per dose and aluminum hydroxide at a concentration of 1 milligram dose (0.35 milligram Al3 +) with phosphate buffered saline as diluent. The vaccine is lyophilized and must be reconstituted with diluent and homogenized at the time of application. The lyophilised vaccine is presented as a white powder and the sterile diluent is translucent. Both are presented in vial of colorless neutral glass. | Biological | MenCC-BIO Vaccine |
| Combined - CRM197The comparison is against meningococcal C vaccine produced by the Foundation Ezequiel Dias (FUNED), licensed by ANVISA and currently provided by the National Immunization Program in the child's immunization schedule. This vaccine containing 10 microgram of meningococcal C oligosaccharide conjugate 12,5-25microgram of CRM197 protein of Corynebacterium diphtheriae, and presents aluminum hydroxide (0.3 to 0.4 milligram Al3 +) in its formulation. It is also a lyophilized product must be reconstituted and homogenized before use. The meningococcal C vaccine adsorbed (combined - CRM197) comprises two frascos- ampoule, containing a white or off-white lyophilized powder and another vial containing a white opalescent suspension (diluent). | Biological | combined - CRM197 |
Primary outcome
Measure seroconversion proportion
Time frame: Immediately before administration of the booster dose
Measure geometric mean antibody titers (TGM)
Time frame: Immediately before administration of the booster dose
Measure frequency and intensity of adverse events solicited and unsolicited
Time frame: 30 days after vaccination
Measure seroconversion proportion
Time frame: 30 days after administration of the booster dose
Measure the ratio of antibody titers
Time frame: 30 days after administration of the booster dose
Measure the ratio antibody titers
Time frame: Immediately before administration of the booster dose
Measure geometric mean antibody titers (TGM)
Time frame: 30 days after administration of the booster dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Individual participant dataSharing planned: No
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.
Tatiana de Noronha, Doc principal investigator
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MenCC-BIO Vaccine and Combined - CRM197 in people with Serogroup C Meningococcal Meningitis, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 1 site in Brazil.
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 7 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 10 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 1 site in Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria LB Santos (+552138827062, maria.santos@bio.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure seroconversion proportion (time frame: Immediately before administration of the booster dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2018.