DenguePhase 2NCT00370682

A Phase II Trial of a Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy Adults in Thailand

A Phase 2 study testing T-DEN F17 and T-DEN F-19 in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.

Completed

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

Official record

Search all trials

Trial summary

This descriptive study will evaluate the safety and immunogenicity of different formulations of the WRAIR dengue vaccine compared to a placebo. Read more about this study

Who is it for?: Ages 20 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Dengue
What is being tested?: T-DEN F17 and T-DEN F-19
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteThailand
Study dates: Apr 2007to Feb 2008
Phase: Phase 2
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 20 to 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A healthy male or female adult 20-25 years of age (≥20 years of age and ≤25 years of age) at the time of vaccination;
Free of obvious health problems as established by medical history and physical examination before entering into the study;
Written informed consent obtained from the subject;
Able to read the Subject Information Sheet and Consent Form;
Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study;
females must be of non-childbearing potential, i.e. surgically sterilized or, if of childbearing potential, she must be abstinent or on adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination, have a negative pregnancy test within 48 hours prior to vaccination and must agree to continue such precautions for 60 days after completion of the vaccination series

Who cannot join

Pregnant or lactating female, planning to become pregnant or planning to discontinue abstinence or contraceptive precautions;
History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood;
History of drug abuse or alcohol consumption (more than 2 drinks per day);
History of allergic disease/reaction likely to be exacerbated by any component of the vaccine;
Acute or chronic, pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect, as determined by physical examination or laboratory tests;
Any confirmed or suspected immunosuppressive or immunodeficient condition or seropositive for HBsAg, anti-HCV or anti-HIV;

Show all 17Show fewer

Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever);
Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness;
Chronic splenomegaly, left upper quadrant abdominal pain or tenderness;
Hypertension; chest pain, palpitations, dizziness, shortness of breath, arrhythmias or friction rubs;
Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine (includes placebo) or planned use during the study period;
Planned administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of the study vaccine/placebo and ending 30 days after the second dose;
A planned move to a location that will prohibit participating in the trial for 9 months after the initial vaccination;
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 90 days preceding the first dose or planned administration during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed;
Administration of immunoglobulins and/or blood products within 90 days preceding the first dose or planned administration during the study period;
Any chronic systemic drug therapy to be continued during the study period (except for vitamin/mineral supplements or routine treatment for gastro-esophageal reflux);
No easy access to a fixed or mobile telephone

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Phramongkutklao Hospital
Bangkok

Other trials in Thailand

About this study

Official title: Phase II, Randomized, Double-blind, Single Center, Controlled Study of Two Doses of Different Formulations of the WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to a Placebo Control, Administered on a 0-6 Month Schedule, to Healthy Adults

This descriptive study will evaluate the safety and immunogenicity of different formulations of the WRAIR dengue vaccine compared to a placebo.

Read the detailed description

Subjects will be randomized into one of three groups. One group will receive a placebo vaccine and the other two will receive different dengue vaccine formations. Each subject will receive two doses six months apart. All subjects will have 11 venipunctures during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.

Conditions: Dengue
Being tested: T-DEN F17, T-DEN F-19, Placebo Comparator
Medical subject headings: Dengue

What participants receive

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

T-DEN F17Biological
Also called T-DEN vaccine
A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
T-DEN F-19Biological
A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
Placebo ComparatorOther
A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Study groups in NCT00370682
Study group	Role	What they receive
T-DEN F17	Experimental	Full Dose (0.5 mL) 0 and 6 months Receives: Biological: T-DEN F17
T-DEN F19	Experimental	Full Dose (0.5 mL) at 0 and 6 months Receives: Biological: T-DEN F-19
Placebo Comparator	Placebo comparator	0.5 mL sterile buffer at 0 and 6, subcutaneous injection Receives: Other: Placebo Comparator

What is being measured

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

Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)
Measured: 0-21 days after dose 1
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month)
Measured: 30 and 90 days after dose 2

Secondary outcomes (9)

Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine
Percentage of subjects with any adverse events (AEs) solicited and unsolicited reported during the 21-day post-vaccination period following dose 2
Measured: 0-21 days after dose 2 of study vaccine
Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose
Incidence of unsolicited AEs reported within the 31-day (Days 0-30) post-vaccination period for each study vaccine
Measured: 0-30 days after each study vaccine dose
Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period
Number of subjects experiencing serious adverse events (SAEs) throughout the entire 9 month study period
Measured: 9 months
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Laboratory valuesabove the alert values within 31 days (days 0-30) after each vaccine dose. Change from baseline in hematological and biochemical levels with respect to normal ranges.
PI(D2, 5, 8, 12) = Post Dose 1, Days 2, 5, 8 and 12 PI(D5, 12,14) = Post Dose 1, Days 5, 12 and 14 PI(M1) = Post Dose 1, Month 1 PI(M6) = Post Dose 1, Month 6 PII(D2, 5, 8, 12) = Post Dose 2, Days 2, 5, 8 and 12 PII(D5, 8, 12, 14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7
Measured: within 31 days after each vaccine dose
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Incidence of abnormal dengue examination findings reported during the 31-Day (Days 0-30) post-vaccination period, per dose
Measured: 31 days post-vaccination per dose
Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period.
Number of subjects with incidence of suspected and confirmed dengue throughout the entire study period.
Measured: 9 months
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
Percentage of subject with Tetravalent responses for neutralizing antibodies, according to pre-vaccination dengue immune status. There was no placebo run for DEN Monovalent.
PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7
Measured: post dose 1 and 2
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
Seropositivity rates for neut. antibodies according to pre-vaccination flavivirus immune status-primed/unprimed subjects.
PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7 PII(M9) = Post Dose 2, Month 9
Measured: 9 months
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
Percentage of subjects with incidence of measurable dengue viremia at specified time points after each dose.
Negative = GEQ/uL results is equal to zero Undetermined = GEQ/uL result is below LOD Positive = GEQ/uL result is >=LOD Missing = No data PI(M1) = Post Dose 1, Month 1 PII(D2,5,8,12) = Post Dose 2, Days 2, 5,8 and 12 PII(D5,8,12,14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7
Measured: within 7 months

Timeline

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

Apr 2007Feb 2008

First posted1 Sep 2006 (estimated)
Study startApr 2007
Primary completionFeb 2008
Study completionFeb 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DengueStudies 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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00370682
Sponsor's protocol ID: WRAIR 1281
Other IDs: Study no: 103854 (T-DEN-002), HSRRB A-13699
Status last verified: May 2017
First submitted: 30 Aug 2006
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: GSK

Publications

Watanaveeradej V, Gibbons RV, Simasathien S, Nisalak A, Jarman RG, Kerdpanich A, Tournay E, De La Barrerra R, Dessy F, Toussaint JF, Eckels KH, Thomas SJ, Innis BL. Safety and immunogenicity of a rederived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial. Am J Trop Med Hyg. 2014 Jul;91(1):119-28. doi: 10.4269/ajtmh.13-0452. Epub 2014 May 27.
PubMed 24865677

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

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All Dengue trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Randomized, Double-blind, Single Center, Controlled Study of Two Doses of Different Formulations of the WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to a Placebo Control, Administered on a 0-6 Month Schedule, to Healthy Adults
ClinicalTrials.gov ID: NCT00370682
Acronym / sponsor ID: WRAIR 1281
Conditions: Dengue
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Collaborators: GlaxoSmithKline
Study start: Apr 2007
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 1 Sep 2006 (estimated)
Results: Posted 30 May 2017

Clinical summary

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

This descriptive study will evaluate the safety and immunogenicity of different formulations of the WRAIR dengue vaccine compared to a placebo.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
T-DEN F17	Experimental	Biological: T-DEN F17Full Dose (0.5 mL) 0 and 6 months
T-DEN F19	Experimental	Biological: T-DEN F-19Full Dose (0.5 mL) at 0 and 6 months
Placebo Comparator	Placebo comparator	Other: Placebo Comparator0.5 mL sterile buffer at 0 and 6, subcutaneous injection

Who may qualify

Ages: 20 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

A healthy male or female adult 20-25 years of age (≥20 years of age and ≤25 years of age) at the time of vaccination;
Free of obvious health problems as established by medical history and physical examination before entering into the study;
Written informed consent obtained from the subject;
Able to read the Subject Information Sheet and Consent Form;
Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study;

Key exclusion criteria (17 listed)

Pregnant or lactating female, planning to become pregnant or planning to discontinue abstinence or contraceptive precautions;
History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood;
History of drug abuse or alcohol consumption (more than 2 drinks per day);
History of allergic disease/reaction likely to be exacerbated by any component of the vaccine;
Acute or chronic, pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect, as determined by physical examination or laboratory tests;

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
T-DEN F17Also: T-DEN vaccineA single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.	Biological	T-DEN F17
T-DEN F-19A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.	Biological	T-DEN F19
Placebo ComparatorA single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.	Other	Placebo Comparator

Primary outcome

Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Time frame: 0-21 days after dose 1
Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
Time frame: 30 and 90 days after dose 2
Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month)

9 secondary outcomes

Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine
Time frame: 0-21 days after dose 2 of study vaccine
Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose
Time frame: 0-30 days after each study vaccine dose
Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period
Time frame: 9 months
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Time frame: within 31 days after each vaccine dose
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Time frame: 31 days post-vaccination per dose
Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period.
Time frame: 9 months
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
Time frame: post dose 1 and 2
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
Time frame: 9 months
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
Time frame: within 7 months

Results and safety

Results posted to the registry on 30 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T-DEN F17	40	40
T-DEN F19	40	37
Placebo Comparator	40	39

Primary outcome: Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1

Time frame: 0-21 days after dose 1. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	T-DEN F17 n = 40	T-DEN F19 n = 40	Placebo Comparator n = 40
Pain	0.0 (0.0 to 8.8)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.8)
Redness	0.0 (0.0 to 8.8)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.8)
Swelling	0.0 (0.0 to 8.8)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.8)
Abdominal Pain	0.0 (0.0 to 8.8)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.8)
Arthralgia	0.0 (0.0 to 8.8)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.8)
Fatigue	2.5 (0.1 to 13.2)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.8)
Fever	2.5 (0.1 to 13.2)	0.0 (0.0 to 9.0)	2.5 (0.1 to 13.2)
Headache	2.5 (0.1 to 13.2)	0.0 (0.0 to 9.0)	0.0 (0.0 to 8.8)

Primary outcome: Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2

Time frame: 30 and 90 days after dose 2. Mean (95% Confidence Interval). Unit: GMTs

Measure	PRE Dose n = 40	PI (M1) n = 40	PII (M7) n = 39	PII (M9) n = 39
DEN-1, F17	172.2 (77.0 to 385.5)	668.7 (348.1 to 1284.3)	958.0 (606.5 to 1513.3)	788.2 (461.9 to 1345.2)
DEN-1, F19	412.6 (205.3 to 829.3)	1111.8 (774.2 to 1596.5)	1233.4 (914.8 to 1663.1)	1061.1 (748.1 to 1505.1)
DEN-1, Placebo	412.9 (218.0 to 782.1)	447.8 (234.5 to 855.4)	441.8 (226.1 to 863.5)	449.2 (240.9 to 837.6)
DEN-2, F17	212.5 (99.0 to 456.2)	860.7 (493.5 to 1501.3)	1085.3 (803.4 to 1466.0)	1168.7 (842.7 to 1620.9)
DEN-2, F19	278.2 (132.2 to 585.6)	1123.7 (762.9 to 1655.0)	1274.5 (946.5 to 1716.4)	1334.1 (1026.4 to 1734.2)
DEN-2, Placebo	180.3 (93.1 to 349.1)	207.4 (106.6 to 403.3)	216.1 (109.5 to 426.5)	231.1 (121.1 to 441.0)
DEN-3, F17	117.5 (52.7 to 261.8)	450.2 (227.6 to 890.5)	507.7 (288.5 to 893.6)	519.3 (287.2 to 939.0)
DEN-3, F19	241.6 (113.9 to 512.6)	787.9 (483.5 to 1283.9)	836.2 (514.0 to 1360.5)	730.3 (425.1 to 1254.6)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T-DEN F17	0 of 40 (0%)	39 of 40 (97.5%)	0 of 40
T-DEN F19	2 of 40 (5%)	34 of 40 (85%)	0 of 40
Placebo Comparator	1 of 40 (2.5%)	35 of 40 (87.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24865677Watanaveeradej V, Gibbons RV, Simasathien S, Nisalak A, Jarman RG, Kerdpanich A, Tournay E, De La Barrerra R, Dessy F, Toussaint JF, Eckels KH, Thomas SJ, Innis BL. Safety and immunogenicity of a rederived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial. Am J Trop Med Hyg. 2014 Jul;91(1):119-28. doi: 10.4269/ajtmh.13-0452. Epub 2014 May 27.
Individual participant dataSharing planned: Yes. GSK

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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.

Robert Gibbons, MD, MPH principal investigator

Department of Virology, Armed Forces Research Institute of Medical Sciences (AFRIMS)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing T-DEN F17 and T-DEN F-19 in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in Thailand.

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 6 inclusion and 17 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 30 May 2017. 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 Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 30 May 2017). 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?

Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 (time frame: 0-21 days after dose 1). The study lists 2 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 NCT00370682, 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 30 May 2017.