Dengue FeverPhase 3NCT01134263

Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

A Phase 3 study testing Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus in people with Dengue Fever and Dengue Hemorrhagic Fever, run by Sanofi Pasteur, a Sanofi Company at 8 sites in Australia.

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 study was to demonstrate that different CYD dengue vaccine lots manufactured using the same method and in the same location but at different times produce an equivalent immunological response after 3 doses. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Dengue Fever, Dengue Hemorrhagic Fever
What is being tested?: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 715 participants
Where: 8 sitesAustralia
Study dates: 5 Oct 2010to Feb 2013
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged 18 to 60 years on the day of inclusion.
Informed consent form was signed and dated.
Able to attend all scheduled visits and to comply with all trial procedures.
For a woman of childbearing potential, use of an effective method of contraception, or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination (i.e., for 14 months).

Who cannot join

Known pregnancy, or a positive urine pregnancy test.
History of flavivirus infection or vaccination or prolonged habitation in a dengue endemic area.
Currently breastfeeding a child.
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
Planned participation in another clinical trial during the present trial period.
Planned receipt of any vaccine in the 4 weeks following any trial vaccination, except for pandemic influenza vaccination.

Show all 14Show fewer

Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
Self-reported seropositivity for human immunodeficiency virus (HIV).
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures.
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Australia8 sites

Study site
Adelaide, SA 5000
Study site
Carina Heights, QLD 4152
Study site
Enoggera, QLD 4051
Study site
Heidelberg, VIC 3084
Study site
Herston, QLD 4006
Study site
Herston, QLD 4029
Study site
Subiaco, WA 6008
Study site
Westmead, NSW 2145

Other trials in Australia

About this study

Official title: Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

Primary Objective

To demonstrate that three different Phase III lots of CYD dengue vaccine induce an equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against the four parental serotypes.

Secondary Objectives:

To demonstrate that data from one Phase II lot and pooled data from Phase III lots of CYD dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs against the four parental serotypes.
To describe the safety of the CYD dengue vaccine in all participants after each dose.

Read the detailed description

All participants received 3 doses of their assigned vaccine or placebo and provided blood samples at defined timepoints for flavivirus status and immunogenicity assessment. Safety data were collected in all participants after each dose and throughout the study.

Conditions: Dengue Fever, Dengue Hemorrhagic Fever
Being tested: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus, Placebo: NaCl 0.9%
Keywords: Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Lot Consistency
Medical subject headings: Dengue, Severe Dengue

What participants receive

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

Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusBiological
Also called CYD Dengue vaccine
0.5 ml, Subcutaneous (SC)
Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusBiological
Also called CYD Dengue vaccine
0.5 ml, SC
Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusBiological
Also called CYD Dengue vaccine
0.5 ml, SC
Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusBiological
Also called CYD Dengue vaccine
0.5 ml, Subcutaneous (SC)
Placebo: NaCl 0.9%Biological
Also called NaCl
0.5 ml, SC

Study groups in NCT01134263
Study group	Role	What they receive
CYD Dengue Vaccine Phase III Lot 1	Experimental	Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1),Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
CYD Dengue vaccine - Phase III Lot 2	Experimental	Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
CYD Dengue vaccine - Phase III Lot 3	Experimental	Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
CYD Dengue vaccine - Phase II Lot	Experimental	Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Receives: Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
Placebo	Placebo comparator	Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Receives: Biological: Placebo: NaCl 0.9%

What is being measured

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

Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.
Measured: 28 days post-injection 3

Secondary outcomes (3)

Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using PRNT assay. Equivalence of Phase III vaccine with Phase II vaccine was assessed by Bridging between Phase III and Phase II Lot of CYD Dengue Vaccine.
Measured: 28 days post-Injection 3
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: Significant; prevents daily activity. Erythema and Swelling: Grade 3: > 10 cm. Participants with Injection Site Reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Measured: 7 days post any vaccination
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Solicited systemic reactions: Asthenia, Fever, Headache, Malaise and Myalgia. Fever: Grade 3: >=39.0°C (>=102.1°F). Headache, malaise, myalgia and asthenia: Grade 3: significant; prevents daily activity. Participants with systemic reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Measured: 14 days post any vaccination

Timeline

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

5 Oct 2010Feb 2013

First posted31 May 2010 (estimated)
Study start5 Oct 2010
Primary completionNov 2012
Study completionFeb 2013

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 (2)Papers the sponsor has linked to this study.
Other trials for Dengue FeverStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 715 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01134263
Sponsor's protocol ID: CYD17
Other IDs: U1111-1114-7646
Status last verified: May 2019
First submitted: 27 May 2010
Last updated: 24 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Torresi J, Heron LG, Qiao M, Marjason J, Chambonneau L, Bouckenooghe A, Boaz M, van der Vliet D, Wallace D, Hutagalung Y, Nissen MD, Richmond PC. Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: a randomised study. Vaccine. 2015 Sep 22;33(39):5127-34. doi: 10.1016/j.vaccine.2015.08.008. Epub 2015 Aug 13.
PubMed 26279339
Torresi J, Richmond PC, Heron LG, Qiao M, Marjason J, Starr-Spires L, van der Vliet D, Jin J, Wartel TA, Bouckenooghe A. Replication and Excretion of the Live Attenuated Tetravalent Dengue Vaccine CYD-TDV in a Flavivirus-Naive Adult Population: Assessment of Vaccine Viremia and Virus Shedding. J Infect Dis. 2017 Oct 17;216(7):834-841. doi: 10.1093/infdis/jix314.
PubMed 28968794

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

Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
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A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
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RecruitingPhase 2
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All Dengue Fever trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
ClinicalTrials.gov ID: NCT01134263
Acronym / sponsor ID: CYD17
Conditions: Dengue Fever, Dengue Hemorrhagic Fever
Keywords: Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Lot Consistency
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 715 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 5 Oct 2010 (actual)
Primary completion: Nov 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 31 May 2010 (estimated)
Results: Posted 24 Jul 2019

Clinical summary

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

Primary Objective

To demonstrate that three different Phase III lots of CYD dengue vaccine induce an equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against the four parental serotypes.

Secondary Objectives:

To demonstrate that data from one Phase II lot and pooled data from Phase III lots of CYD dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs against the four parental serotypes.
To describe the safety of the CYD dengue vaccine in all participants after each dose.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
CYD Dengue Vaccine Phase III Lot 1	Experimental	Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusParticipants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1),Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
CYD Dengue vaccine - Phase III Lot 2	Experimental	Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusParticipants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
CYD Dengue vaccine - Phase III Lot 3	Experimental	Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusParticipants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
CYD Dengue vaccine - Phase II Lot	Experimental	Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusParticipants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Placebo	Placebo comparator	Biological: Placebo: NaCl 0.9%Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Aged 18 to 60 years on the day of inclusion.
Informed consent form was signed and dated.
Able to attend all scheduled visits and to comply with all trial procedures.
For a woman of childbearing potential, use of an effective method of contraception, or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination (i.e., for 14 months).

Key exclusion criteria (14 listed)

Known pregnancy, or a positive urine pregnancy test.
History of flavivirus infection or vaccination or prolonged habitation in a dengue endemic area.
Currently breastfeeding a child.
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
Planned participation in another clinical trial during the present trial period.

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
Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusAlso: CYD Dengue vaccine0.5 ml, Subcutaneous (SC)	Biological	CYD Dengue Vaccine Phase III Lot 1
Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusAlso: CYD Dengue vaccine0.5 ml, SC	Biological	CYD Dengue vaccine - Phase III Lot 2
Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusAlso: CYD Dengue vaccine0.5 ml, SC	Biological	CYD Dengue vaccine - Phase III Lot 3
Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virusAlso: CYD Dengue vaccine0.5 ml, Subcutaneous (SC)	Biological	CYD Dengue vaccine - Phase II Lot
Placebo: NaCl 0.9%Also: NaCl0.5 ml, SC	Biological	Placebo

Primary outcome

Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
Time frame: 28 days post-injection 3
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.

3 secondary outcomes

Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
Time frame: 28 days post-Injection 3
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Time frame: 7 days post any vaccination
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Time frame: 14 days post any vaccination

Results and safety

Results posted to the registry on 24 Jul 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
CYD Dengue Vaccine Phase III Lot 1	164	140
CYD Dengue Vaccine Phase III Lot 2	163	143
CYD Dengue Vaccine Phase III Lot 3	163	134
CYD Dengue Vaccine Phase II Lot	168	149
Placebo	57	48

Primary outcome: Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine

Time frame: 28 days post-injection 3. Geometric mean (95% Confidence Interval). Unit: Titer (1/dilution)

Measure	CYD Dengue Vaccine Phase III Lot 1 n = 129	CYD Dengue Vaccine Phase III Lot 2 n = 123	CYD Dengue Vaccine Phase III Lot 3 n = 124
Dengue Virus Serotype 1	20.6 (16.9 to 25.1)	18.1 (14.8 to 22.2)	17.1 (13.9 to 21.2)
Dengue Virus Serotype 2	65.9 (50.6 to 85.7)	44.1 (33.3 to 58.3)	58.1 (43.2 to 78.2)
Dengue Virus Serotype 3	74.2 (60.1 to 91.7)	65 (53.2 to 79.3)	71.6 (58.2 to 88.2)
Dengue Virus Serotype 4	131.8 (101.4 to 171.3)	94.6 (75.3 to 118.7)	108.5 (84.2 to 139.7)

CYD Dengue Vaccine Phase III Lot 1 vs CYD Dengue Vaccine Phase III Lot 2: Difference of Log10 GMT: 0.055 (95% CI -0.067 to 0.178)
CYD Dengue Vaccine Phase III Lot 2 vs CYD Dengue Vaccine Phase III Lot 3: Difference of Log10 GMT: 0.024 (95% CI -0.102 to 0.151)
CYD Dengue Vaccine Phase III Lot 1 vs CYD Dengue Vaccine Phase III Lot 3: Difference of Log10 GMT: -0.080 (95% CI -0.204 to 0.045)

Population analysed: Analysis was performed on Per-protocol analysis set which included participants who received at least 1 dose of the study vaccine or placebo and had no protocol deviations. Data for this outcome measure was not planned to be collected and analyzed for Phase II Lot and placebo.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CYD Dengue Vaccine Phase III Lot 1	10 of 163 (6.1%)	136 of 163 (83.4%)	0 of 163
CYD Dengue Vaccine Phase III Lot 2	9 of 161 (5.6%)	131 of 161 (81.4%)	0 of 161
CYD Dengue Vaccine Phase III Lot 3	5 of 164 (3%)	135 of 164 (82.3%)	0 of 164
CYD Dengue Vaccine Phase II Lot	9 of 167 (5.4%)	140 of 167 (83.8%)	0 of 167
Placebo	1 of 57 (1.8%)	41 of 57 (71.9%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26279339Torresi J, Heron LG, Qiao M, Marjason J, Chambonneau L, Bouckenooghe A, Boaz M, van der Vliet D, Wallace D, Hutagalung Y, Nissen MD, Richmond PC. Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: a randomised study. Vaccine. 2015 Sep 22;33(39):5127-34. doi: 10.1016/j.vaccine.2015.08.008. Epub 2015 Aug 13.
Derived from this study: PubMed 28968794Torresi J, Richmond PC, Heron LG, Qiao M, Marjason J, Starr-Spires L, van der Vliet D, Jin J, Wartel TA, Bouckenooghe A. Replication and Excretion of the Live Attenuated Tetravalent Dengue Vaccine CYD-TDV in a Flavivirus-Naive Adult Population: Assessment of Vaccine Viremia and Virus Shedding. J Infect Dis. 2017 Oct 17;216(7):834-841. doi: 10.1093/infdis/jix314.

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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.

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

Questions about this trial

What is this clinical trial studying?

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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Australia. 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 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 24 Jul 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?

Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine (time frame: 28 days post-injection 3). 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 NCT01134263, which also lists 2 linked publications.

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 24 Jul 2019.