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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01134263




Registration number
NCT01134263
Ethics application status
Date submitted
27/05/2010
Date registered
31/05/2010
Date last updated
24/07/2019

Titles & IDs
Public title
Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Scientific title
Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Secondary ID [1] 0 0
U1111-1114-7646
Secondary ID [2] 0 0
CYD17
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dengue Fever 0 0
Dengue Hemorrhagic Fever 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
Treatment: Other - Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
Treatment: Other - Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
Treatment: Other - Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
Treatment: Other - Placebo: NaCl 0.9%

Experimental: CYD Dengue Vaccine Phase III Lot 1 - 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.

Experimental: CYD Dengue vaccine - Phase III Lot 2 - 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.

Experimental: CYD Dengue vaccine - Phase III Lot 3 - 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.

Experimental: CYD Dengue vaccine - Phase II Lot - 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.

Placebo comparator: Placebo - 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.


Treatment: Other: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, Subcutaneous (SC)

Treatment: Other: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, SC

Treatment: Other: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, SC

Treatment: Other: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 ml, Subcutaneous (SC)

Treatment: Other: Placebo: NaCl 0.9%
0.5 ml, SC
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
28 days post-injection 3
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
28 days post-Injection 3
Secondary outcome [2] 0 0
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Timepoint [2] 0 0
7 days post any vaccination
Secondary outcome [3] 0 0
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Timepoint [3] 0 0
14 days post any vaccination

Eligibility
Key inclusion criteria
* 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).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.
* 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
715
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Carina Heights
Recruitment hospital [3] 0 0
- Enoggera
Recruitment hospital [4] 0 0
- Heidelberg
Recruitment hospital [5] 0 0
- Herston
Recruitment hospital [6] 0 0
- Subiaco
Recruitment hospital [7] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [2] 0 0
QLD 4152 - Carina Heights
Recruitment postcode(s) [3] 0 0
QLD 4051 - Enoggera
Recruitment postcode(s) [4] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
QLD 4006 - Herston
Recruitment postcode(s) [6] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [7] 0 0
WA 6008 - Subiaco
Recruitment postcode(s) [8] 0 0
NSW 2145 - Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.

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.
Trial website
https://clinicaltrials.gov/study/NCT01134263
Trial related presentations / 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Sanofi Pasteur Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01134263