DiphtheriaPhase 3NCT00404651

Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

A Phase 3 study testing DTaP-IPV-HB-PRP~T vaccine and DTaP-HBV-IPV vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 6 sites in Mexico.

Completed

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

Official record

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Trial summary

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent. The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and… Read more about this study

Who is it for?: Ages 2 months and olderHealthy volunteers can take part
Conditions the study is for: Diphtheria, Tetanus, Pertussis
What is being tested?: DTaP-IPV-HB-PRP~T vaccine and DTaP-HBV-IPV vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,189 participants
Where: 6 sitesMexico
Study dates: Nov 2006to 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 2 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Two months old infants on the day of inclusion
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
Informed consent form signed by one or both parents or by the guardian and two independent witnesses
Able to attend all scheduled visits and to comply with all trial procedures
Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.

Who cannot join

Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency
Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or 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 since birth

Show all 14Show fewer

Any vaccination in the four weeks preceding the first trial visit
Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
History of seizures
Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Mexico6 sites

Study site
Estado de México, 56613
Study site
Estado de México
Study site
Insurgentes Cuicuilco
Study site
Monterrey
Study site
Puebla City
Study site
Tlalpan, 14050

Other trials in Mexico

About this study

Official title: Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.

The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.

The secondary objectives are:

To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
To assess the overall safety in each group one month after the third dose of the primary series.

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

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)
DTaP-IPV-HB-PRP~T vaccineBiological
0.5 mL, IM
DTaP-IPV-HB-PRP~T vaccineBiological
0.5 mL, IM
DTaP-HBV-IPV vaccineBiological
Also called INFANRIX®HEXA
0.5 mL, IM

Study groups in NCT00404651
Study group	Role	What they receive
Group 1	Experimental	Participants receive vaccine Batch A Receives: Biological: DTaP-IPV-HB-PRP~T vaccine
Group 2	Experimental	Participants receive vaccine Batch B Receives: Biological: DTaP-IPV-HB-PRP~T vaccine
Group 3	Experimental	Participants receive vaccine Batch C Receives: Biological: DTaP-IPV-HB-PRP~T vaccine
Group 4	Active comparator	Participants receive Infanrix hexa™ Receives: Biological: DTaP-HBV-IPV vaccine

What is being measured

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

Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
Measured: Day 150 (one month post-dose 3)
Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.
Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
Measured: Day 150 (one month post-dose 3)
Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).
Measured: Day 150 (one month post-dose 3)

Secondary outcomes (2)

Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).
Measured: Day 150 (one month post-dose 3)
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever ([pyrexia] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability
Measured: Day 0 (pre-each vaccination) up to 7 days post-each dose

Timeline

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

Nov 2006Jul 2008

First posted29 Nov 2006 (estimated)
Study startNov 2006
Primary completionApr 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,189 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00404651
Sponsor's protocol ID: A3L11
Status last verified: Apr 2014
First submitted: 28 Nov 2006
Last updated: 9 May 2014
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 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants
ClinicalTrials.gov ID: NCT00404651
Acronym / sponsor ID: A3L11
Conditions: Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis
Keywords: Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Invasive Haemophilus influenzae type b.
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,189 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Apr 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 29 Nov 2006 (estimated)
Results: Posted 9 May 2014

Clinical summary

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

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.

The secondary objectives are:

To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
To assess the overall safety in each group one month after the third dose of the primary series.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Biological: DTaP-IPV-HB-PRP~T vaccineParticipants receive vaccine Batch A
Group 2	Experimental	Biological: DTaP-IPV-HB-PRP~T vaccineParticipants receive vaccine Batch B
Group 3	Experimental	Biological: DTaP-IPV-HB-PRP~T vaccineParticipants receive vaccine Batch C
Group 4	Active comparator	Biological: DTaP-HBV-IPV vaccineParticipants receive Infanrix hexa™

Who may qualify

Ages: 2 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Two months old infants on the day of inclusion
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
Informed consent form signed by one or both parents or by the guardian and two independent witnesses
Able to attend all scheduled visits and to comply with all trial procedures
Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.

Key exclusion criteria (14 listed)

Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency
Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or 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	Group 1
DTaP-IPV-HB-PRP~T vaccine0.5 mL, IM	Biological	Group 2
DTaP-IPV-HB-PRP~T vaccine0.5 mL, IM	Biological	Group 3
DTaP-HBV-IPV vaccineAlso: INFANRIX®HEXA0.5 mL, IM	Biological	Group 4

Primary outcome

Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
Time frame: Day 150 (one month post-dose 3)
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.
Time frame: Day 150 (one month post-dose 3)
Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Time frame: Day 150 (one month post-dose 3)
Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).

2 secondary outcomes

Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Time frame: Day 150 (one month post-dose 3)
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Time frame: Day 0 (pre-each vaccination) up to 7 days post-each dose

Results and safety

Results posted to the registry on 9 May 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-HB-PRP~T Batch 1	340	301
DTaP-IPV-HB-PRP~T Batch 2	343	315
DTaP-IPV-HB-PRP~T Batch 3	339	294
Infanrix Hexa™	167	146

Primary outcome: Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine

Time frame: Day 150 (one month post-dose 3). Number. Unit: Participants

Measure	DTaP-IPV-HB-PRP~T Batch 1 n = 231	DTaP-IPV-HB-PRP~T Batch 2 n = 236	DTaP-IPV-HB-PRP~T Batch 3 n = 228	Infanrix Hexa™ n = 119
Anti-Hep B (N = 230, 234, 236, 119)	226	231 (0 to 0)	221 (0 to 0)	119 (0 to 0)
Anti-PRP (N = 231, 236, 228, 119)	229	232 (0 to 0)	226 (0 to 0)	118 (0 to 0)
Anti-Diphtheria (N = 231, 236, 228, 119)	220	228 (0 to 0)	222 (0 to 0)	118 (0 to 0)
Anti-Tetanus (N = 231, 236, 227, 119)	231	236 (0 to 0)	227 (0 to 0)	119 (0 to 0)

Population analysed: Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint.

Primary outcome: Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.

Time frame: Day 150 (one month post-dose 3). Number. Unit: Participants

Measure	DTaP-IPV-HB-PRP~T Batch 1 n = 231	DTaP-IPV-HB-PRP~T Batch 2 n = 236	DTaP-IPV-HB-PRP~T Batch 3 n = 228	Infanrix Hexa™ n = 119
Anti-Pertussis (N= 228, 234, 223, 118)	223	226 (0 to 0)	218 (0 to 0)	113 (0 to 0)
Anti-FHA (N= 227, 233, 221, 115)	225	229 (0 to 0)	216 (0 to 0)	111 (0 to 0)

Population analysed: Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).

Primary outcome: Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine

Time frame: Day 150 (one month post-dose 3). Number. Unit: Participants

Measure	DTaP-IPV-HB-PRP~T Batch 1 n = 231	DTaP-IPV-HB-PRP~T Batch 2 n = 236	DTaP-IPV-HB-PRP~T Batch 3 n = 228	Infanrix Hexa™ n = 119
Anti-Polio 1 (N = 231, 236, 225, 119)	230	236 (0 to 0)	225 (0 to 0)	119 (0 to 0)
Anti-Polio 2 (N = 230, 236, 226, 118)	230	236 (0 to 0)	226 (0 to 0)	118 (0 to 0)
Anti-Polio 3 (N = 230, 236, 226, 119)	229	235 (0 to 0)	226 (0 to 0)	117 (0 to 0)

Population analysed: Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from Day 0 after the first vaccination for up to 10 months (Day 300) post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DTaP-IPV-HB-PRP~T Batch 1	5 of 337 (1.5%)	220 of 337 (65.3%)	Not reported
DTaP-IPV-HB-PRP~T Batch 2	5 of 345 (1.4%)	237 of 345 (68.7%)	Not reported
DTaP-IPV-HB-PRP~T Batch 3	12 of 340 (3.5%)	225 of 340 (66.2%)	Not reported
Infanrix Hexa™	6 of 167 (3.6%)	95 of 167 (56.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Diphtheria

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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.

6 sites 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 and DTaP-HBV-IPV vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 6 sites in Mexico.

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 5 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Mexico. 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 9 May 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?

Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine (time frame: Day 150 (one month post-dose 3)). 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 NCT00404651.

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 May 2014.