DiphtheriaPhase 3NCT00619502

Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

A Phase 3 study testing DTaP-IPV-HB-PRP~T vaccine in people with Diphtheria and Polio, run by Sanofi Pasteur, a Sanofi Company at 1 site in Turkey (Türkiye).

Completed

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

Official record

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Trial summary

This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®. To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T. Read more about this study

Who is it for?: Ages 15 to 18 monthsHealthy volunteers can take part
Conditions the study is for: Diphtheria, Polio, Pertussis
What is being tested?: DTaP-IPV-HB-PRP~T vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 254 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Dec 2007to Jul 2008
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 15 to 18 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age.
Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).
Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator.
Able to attend all scheduled visits and to comply with all trial procedures.

Who cannot join

Participation in another clinical trial in the 4 weeks preceding the booster vaccination.
Planned participation in another clinical trial during the present trial period.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy.
Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion.
Blood or blood-derived products received in the last 3 months.

Show all 14Show fewer

Any vaccination in the 4 weeks preceding the booster vaccination.
Any vaccination planned until second Visit.
History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s).
Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
Any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10 (NCT00315055).
Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; temperature > 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for > 3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Study site
Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Immunogenicity and Safety Study of a Booster Dose of DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series at 2, 3 and 4 Months of Age in Healthy Turkish Infants

This is a follow-up of Study A3L10 (NCT00315055)

Immunogenicity

To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.
To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.

Safety

To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.

Conditions: Diphtheria, Polio, Pertussis, Hepatitis B
Being tested: DTaP-IPV-HB-PRP~T vaccine
Keywords: Hepatitis B, Polio, Diphtheria, Pertussis, H.influenzae type b
Medical subject headings: Diphtheria, Poliomyelitis, Whooping Cough, Hepatitis B

What participants receive

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

DTaP-IPV-HB-PRP~T vaccineBiological
0.5 mL, intramuscular (IM)

Study groups in NCT00619502
Study group	Role	What they receive
DTaP-IPV-Hep B-PRP~T Vaccine Group	Experimental	Participants received a primary series of 3 vaccinations with DTaP-IPV-Hep B-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study Receives: Biological: DTaP-IPV-HB-PRP~T vaccine
Pentaxim™ + Engerix B™ Vaccines Group	Active comparator	Participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study. Receives: Biological: DTaP-IPV-HB-PRP~T vaccine

What is being measured

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

Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™
Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.
Measured: Day 0 before and Day 30 Post-booster vaccination
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).
Measured: Day 0 before and Day 30 post-booster vaccination
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability.
Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable.
Measured: Day 0 up to Day 7 post-booster vaccination

Timeline

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

Dec 2007Jul 2008

First posted21 Feb 2008 (estimated)
Study startDec 2007
Primary completionJul 2008
Study completionJul 2008

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.
Other trials for DiphtheriaStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00619502
Sponsor's protocol ID: A3L22
Status last verified: Apr 2016
First submitted: 11 Feb 2008
Last updated: 13 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines

All Diphtheria trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of a Booster Dose of DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series at 2, 3 and 4 Months of Age in Healthy Turkish Infants
ClinicalTrials.gov ID: NCT00619502
Acronym / sponsor ID: A3L22
Conditions: Diphtheria, Polio, Pertussis, Hepatitis B
Keywords: Hepatitis B, Polio, Diphtheria, Pertussis, H.influenzae type b
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 254 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Posted 3 Apr 2014

Clinical summary

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

This is a follow-up of Study A3L10 (NCT00315055)

Immunogenicity

To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.
To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.

Safety

To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DTaP-IPV-Hep B-PRP~T Vaccine Group	Experimental	Biological: DTaP-IPV-HB-PRP~T vaccineParticipants received a primary series of 3 vaccinations with DTaP-IPV-Hep B-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study
Pentaxim™ + Engerix B™ Vaccines Group	Active comparator	Biological: DTaP-IPV-HB-PRP~T vaccineParticipants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.

Who may qualify

Ages: 15 to 18 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age.
Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).
Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator.
Able to attend all scheduled visits and to comply with all trial procedures.

Key exclusion criteria (14 listed)

Participation in another clinical trial in the 4 weeks preceding the booster vaccination.
Planned participation in another clinical trial during the present trial period.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy.
Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion.

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
DTaP-IPV-HB-PRP~T vaccine0.5 mL, intramuscular (IM)	Biological	DTaP-IPV-Hep B-PRP~T Vaccine Group, Pentaxim™ + Engerix B™ Vaccines Group

Primary outcome

Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™
Time frame: Day 0 before and Day 30 Post-booster vaccination
Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA.
Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Time frame: Day 0 before and Day 30 post-booster vaccination
Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA).
Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Time frame: Day 0 up to Day 7 post-booster vaccination
Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable.

Results and safety

Results posted to the registry on 3 Apr 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
DTaP-IPV-HepB-PRP~T	130	122
Pentaxim™ + Engerix B™	124	114

Primary outcome: Percentage of Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™

Time frame: Day 0 before and Day 30 Post-booster vaccination. Number. Unit: Percentage of Participants

Measure	DTaP-IPV-HepB-PRP~T n = 114	Pentaxim™ + Engerix B™ n = 103
Anti-Hep B Pre-booster (N = 109, 103)	81	99
Anti-Hep B Post-booster (N = 111, 103)	97	100
Anti-PRP Pre-booster (N = 113,102)	85	83
Anti-PRP Post-booster (N = 114, 103)	100	100
Anti-Diphtheria Pre-booster (N = 104, 94)	90	88
Anti-Diphtheria Post-booster (N = 112, 98)	100	100
Anti-Tetanus Pre-booster (N = 97, 90)	100	100
Anti-Tetanus Post-booster (N = 109, 96)	100	100

Population analysed: Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation.

Primary outcome: Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T

Time frame: Day 0 before and Day 30 post-booster vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	DTaP-IPV-HepB-PRP~T n = 114	Pentaxim™ + Engerix B™ n = 103
Anti-Hep B Pre-booster (N = 109, 103)	44.2 (32.3 to 60.7)	223 (176 to 282)
Anti-Hep B Post-booster (N = 111, 103)	1379 (916 to 2078)	26189 (19133 to 35846)
Anti-PRP Pre-booster (N = 113, 102)	0.724 (0.541 to 0.968)	0.612 (0.443 to 0.844)
Anti-PRP Post-booster (N = 114, 103)	72.5 (55.8 to 94.3)	86.9 (69.8 to 108)
Anti-Diphtheria Pre-booster (N = 104, 94)	0.028 (0.022 to 0.035)	0.032 (0.024 to 0.041)
Anti-Diphtheria Post-booster (N = 112, 98)	5.09 (3.89 to 6.66)	10.2 (7.59 to 13.8)
Anti-Tetanus Pre-booster (N = 97, 90)	0.244 (0.204 to 0.292)	0.194 (0.158 to 0.238)
Anti-Tetanus Post-booster (N = 109, 96)	8.98 (7.52 to 10.7)	13.1 (10.8 to 15.8)

Population analysed: GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population).

Primary outcome: Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T

Time frame: Day 0 up to Day 7 post-booster vaccination. Number. Unit: Participants

Measure	DTaP-IPV-HepB-PRP-T n = 121	Pentaxim™ + Engerix B™ n = 111
Pain	56	67
Grade 3 Pain	4	2
Erythema	35	50
Grade 3 Erythema	3	4
Swelling	26	36
Grade 3 Swelling	2	3
Extensive Swelling of Vaccinated Limb	0	0
Pyrexia	29	36

Population analysed: Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP\~T according to the primary series received (Safety Analysis Population).

Adverse events

Time frame: Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DTaP-IPV-HepB-PRP~T	4 of 130 (3.1%)	56 of 130 (43.1%)	Not reported
Pentaxim™ + Engerix B™	2 of 124 (1.6%)	67 of 124 (54%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical 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 3 study testing DTaP-IPV-HB-PRP~T vaccine in people with Diphtheria and Polio, run by Sanofi Pasteur, a Sanofi Company at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 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 13 May 2016. 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 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 Participants With Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ (time frame: Day 0 before and Day 30 Post-booster vaccination). The study lists 3 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 NCT00619502.

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 13 May 2016.