Hepatitis BPhase 3NCT02759354

Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)

A Phase 3 study testing Blood Sample in people with Hepatitis B and Pertussis, run by MCM Vaccines B.V..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old children previously vaccinated with Vaxelis® or INFANRIX® hexa Read more about this study

Who is it for?: Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis B, Pertussis
What is being tested?: Blood Sample
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 754 participants
Where: No sites listed yet
Study dates: 26 Apr 2016to 1 Aug 2016
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 3 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy child of either gender, who has received a complete 3-dose primary series or a complete 2 dose primary series followed by a toddler dose with VAXELIS or INFANRIX hexa as part of the V419-007 or V419-008 study respectively.
Informed consent signed by the participant's parent(s) or legal representative.

Who cannot join

Participant who has received any dose of hepatitis B (HB)-containing vaccine at any time other than study vaccine in V419-007 or V419-008 study.
Participant with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study.
Participant who has received any dose of pertussis-containing vaccine after completion of the V419-008 study.
Participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study.
Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure*.
Participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion*.

Show all 9Show fewer

Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008 studies.
Participant with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of V419-007 or V419-008 studies.
Criteria 5 and 6 are temporary exclusion criteria. If a participant meets criteria 5 and/or 6 at the time of Visit 1, a further appointment is to be scheduled to reassess the participant's eligibility.

About this study

Official title: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year-Old Children Previously Vaccinated With a 2-Dose or 3-Dose Infants Series and Toddler Dose With Vaxelis® or INFANRIX® Hexa

Conditions: Hepatitis B, Pertussis
Being tested: Blood Sample
Keywords: Immune response
Medical subject headings: Hepatitis B, Whooping Cough

What participants receive

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

Blood SampleOther
Also called Vaxelis®, INFANRIX® hexa
Blood sample at approx. 4 years of age

Study groups in NCT02759354
Study group	Role	What they receive
Group Vaxelis (3+1)	Experimental	Participants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). Receives: Other: Blood Sample
Group Infanrix hexa (3+1)	Active comparator	Participants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007). Receives: Other: Blood Sample
Group Vaxelis (2+1)	Experimental	Participants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). Receives: Other: Blood Sample
Group Infanrix hexa (2+1)	Active comparator	Participants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008). Receives: Other: Blood Sample

What is being measured

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

Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. Response was defined as a titer >=10 milli International units (mIU)/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Measured: Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)
Percentage of Participants Responding to Pertussis Toxin
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. The unit of measure is ELISA units/mL. The lower limit of quantification (LLOQ)=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Measured: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. LLOQ=3 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Measured: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Percentage of Participants Responding to Pertussis Pertactin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Measured: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Percentage of Participants Responding to Pertussis Fimbriae
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Measured: Day 1 (approximately 4 years after completion of the 2+1 schedule)

Secondary outcomes (5)

Geometric Mean Concentration of Antibodies to HBsAg
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. The unit of measure is milli International Units/mL (mIU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.
Measured: Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
Geometric Mean Concentration of Antibodies to Pertussis Toxin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.
Measured: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.
Measured: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.
Measured: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.
Measured: Day 1 (approximately 4 years after completion of the 2+1 schedule)

Timeline

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

26 Apr 20161 Aug 2016

First posted3 May 2016 (estimated)
Study start26 Apr 2016
Primary completion29 Jul 2016
Study completion1 Aug 2016

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 Hepatitis BStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 754 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02759354
Sponsor's protocol ID: V419-012
Other IDs: 2016-000274-37, PRI03C, V419-012, 2016
Status last verified: May 2020
First submitted: 29 Apr 2016
Last updated: 9 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Vesikari T, Xu J, Johnson DR, Hall J, Marcek T, Goveia MG, Acosta CJ, Lee AW. Hepatitis B and pertussis antibodies in 4- to 5-year-old children previously vaccinated with different hexavalent vaccines. Hum Vaccin Immunother. 2020 Apr 2;16(4):867-874. doi: 10.1080/21645515.2019.1673119. Epub 2019 Nov 5.
PubMed 31689166

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?

Official record

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year-Old Children Previously Vaccinated With a 2-Dose or 3-Dose Infants Series and Toddler Dose With Vaxelis® or INFANRIX® Hexa
ClinicalTrials.gov ID: NCT02759354
Acronym / sponsor ID: V419-012
Conditions: Hepatitis B, Pertussis
Keywords: Immune response
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 754 participants (actual)
Lead sponsor: MCM Vaccines B.V.Industry (pharma, biotech, devices)
Collaborators: Merck Sharp & Dohme LLC, Sanofi Pasteur, a Sanofi Company
Study start: 26 Apr 2016 (actual)
Primary completion: 29 Jul 2016 (actual)
Study completion: 1 Aug 2016 (actual)
First posted: 3 May 2016 (estimated)
Results: Posted 27 Jun 2019

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group Vaxelis (3+1)	Experimental	Other: Blood SampleParticipants previously vaccinated with a 3-dose primary series of Vaxelis® at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007).
Group Infanrix hexa (3+1)	Active comparator	Other: Blood SampleParticipants previously vaccinated with a 3-dose primary series of INFANRIX® hexa at 2, 3 and 4 months of age, and a toddler dose at 12 months of age (study V419-007).
Group Vaxelis (2+1)	Experimental	Other: Blood SampleParticipants previously vaccinated with a 2-dose primary series of Vaxelis® at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008).
Group Infanrix hexa (2+1)	Active comparator	Other: Blood SampleParticipants previously vaccinated with a 2-dose primary series of INFANRIX® hexa at 2 and 4 months of age, and a toddler dose at 11-12 months of age (study V419-008).

Who may qualify

Ages: 3 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy child of either gender, who has received a complete 3-dose primary series or a complete 2 dose primary series followed by a toddler dose with VAXELIS or INFANRIX hexa as part of the V419-007 or V419-008 study respectively.
Informed consent signed by the participant's parent(s) or legal representative.

Key exclusion criteria (9 listed)

Participant who has received any dose of hepatitis B (HB)-containing vaccine at any time other than study vaccine in V419-007 or V419-008 study.
Participant with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study.
Participant who has received any dose of pertussis-containing vaccine after completion of the V419-008 study.
Participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study.
Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure*.

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
Blood SampleAlso: Vaxelis®, INFANRIX® hexaBlood sample at approx. 4 years of age	Other	Group Infanrix hexa (2+1), Group Infanrix hexa (3+1), Group Vaxelis (2+1), Group Vaxelis (3+1)

Primary outcome

Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)
Time frame: Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. Response was defined as a titer >=10 milli International units (mIU)/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Toxin
Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. The unit of measure is ELISA units/mL. The lower limit of quantification (LLOQ)=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. LLOQ=3 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Pertactin
Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.
Percentage of Participants Responding to Pertussis Fimbriae
Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.

5 secondary outcomes

Geometric Mean Concentration of Antibodies to HBsAg
Time frame: Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)
Geometric Mean Concentration of Antibodies to Pertussis Toxin
Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)

Results and safety

Results posted to the registry on 27 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group Vaxelis (3+1)	192	192
Group Infanrix Hexa (3+1)	190	190
Group Vaxelis (2+1)	181	181
Group Infanrix Hexa (2+1)	191	191

Primary outcome: Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)

Time frame: Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Group Vaxelis (3+1) n = 191	Group Infanrix Hexa (3+1) n = 189	Group Vaxelis (2+1) n = 181	Group Infanrix Hexa (2+1) n = 190
Value	70.16 (63.13 to 76.55)	82.01 (75.78 to 87.21)	65.75 (58.34 to 72.63)	83.68 (77.65 to 88.64)

Population analysed: All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated (with a complete 3+1 or 2+1 schedule, as part of studies V419-007 or V419-008) with available immunogenicity data for the respective endpoint.

Primary outcome: Percentage of Participants Responding to Pertussis Toxin

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group Vaxelis (2+1) n = 178	Group Infanrix Hexa (2+1) n = 188
Concentration ≥LLOQ	58.43 (50.82 to 65.75)	41.49 (34.37 to 48.89)
Concentration ≥2×LLOQ	40.45 (33.17 to 48.05)	21.81 (16.13 to 28.40)
Concentration ≥4×LLOQ	14.61 (9.77 to 20.67)	3.72 (1.51 to 7.52)

Population analysed: The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007).

Primary outcome: Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group Vaxelis (2+1) n = 173	Group Infanrix Hexa (2+1) n = 188
Concentration ≥LLOQ	80.92 (74.27 to 86.49)	88.30 (82.82 to 92.52)
Concentration ≥2×LLOQ	46.82 (39.21 to 54.54)	70.74 (63.68 to 77.14)
Concentration ≥4×LLOQ	26.01 (19.65 to 33.22)	45.21 (37.96 to 52.62)

Primary outcome: Percentage of Participants Responding to Pertussis Pertactin

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group Vaxelis (2+1) n = 180	Group Infanrix Hexa (2+1) n = 190
Concentration ≥LLOQ	66.11 (58.70 to 72.99)	72.63 (65.71 to 78.84)
Concentration ≥2×LLOQ	43.89 (36.52 to 51.47)	51.05 (43.71 to 58.36)
Concentration ≥4×LLOQ	15.56 (10.59 to 21.69)	18.42 (13.18 to 24.68)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 days after Day 1. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group Vaxelis (3+1)	0 of 191 (0%)	0 of 191 (0%)	Not reported
Group Infanrix Hexa (3+1)	0 of 189 (0%)	0 of 189 (0%)	Not reported
Group Vaxelis (2+1)	0 of 181 (0%)	0 of 181 (0%)	Not reported
Group Infanrix Hexa (2+1)	0 of 191 (0%)	0 of 191 (0%)	Not reported

Limitations and caveats (from the sponsor): Vaccine safety was not assessed in the present study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31689166Vesikari T, Xu J, Johnson DR, Hall J, Marcek T, Goveia MG, Acosta CJ, Lee AW. Hepatitis B and pertussis antibodies in 4- to 5-year-old children previously vaccinated with different hexavalent vaccines. Hum Vaccin Immunother. 2020 Apr 2;16(4):867-874. doi: 10.1080/21645515.2019.1673119. Epub 2019 Nov 5.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
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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

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Blood Sample in people with Hepatitis B and Pertussis, run by MCM Vaccines B.V..

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 2 inclusion and 9 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

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 27 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg) (time frame: Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)). The study lists 5 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 NCT02759354, 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 Jun 2020.