Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
2 other identifiers
interventional
715
1 country
8
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2010
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedStudy Start
First participant enrolled
October 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
July 24, 2019
CompletedJuly 24, 2019
May 1, 2019
2.1 years
May 27, 2010
May 21, 2019
May 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
28 days post-Injection 3
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
7 days post any vaccination
Number of Participants With Solicited Systemic Reactions After Any Vaccination
14 days post any vaccination
Study Arms (5)
CYD Dengue Vaccine Phase III Lot 1
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Interventions
0.5 ml, Subcutaneous (SC)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Adelaide, SA 5000, Australia
Unknown Facility
Carina Heights, QLD 4152, Australia
Unknown Facility
Enoggera, QLD 4051, Australia
Unknown Facility
Heidelberg, VIC 3084, Australia
Unknown Facility
Herston, QLD 4006, Australia
Unknown Facility
Herston, QLD 4029, Australia
Unknown Facility
Subiaco, WA 6008, Australia
Unknown Facility
Westmead, NSW 2145, Australia
Related Publications (2)
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.
PMID: 26279339RESULTTorresi 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.
PMID: 28968794DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- An observer-blind procedure was followed for the three injections with CYD dengue vaccine or placebo. Neither the observer, Investigator, Sponsor, nor the participant knew which product was administered.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2010
First Posted
May 31, 2010
Study Start
October 5, 2010
Primary Completion
November 1, 2012
Study Completion
February 1, 2013
Last Updated
July 24, 2019
Results First Posted
July 24, 2019
Record last verified: 2019-05