Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01134263
First received: May 27, 2010
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

The purpose of this study is 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.

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 (in terms of solicited injection site and systemic reactions and unsolicited adverse events) of the CYD Dengue vaccine in all subjects after each dose.

Condition Intervention Phase
Dengue Fever
Dengue Hemorrhagic Fever
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
Biological: Placebo: NaCl 0.9%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lot-to-Lot Consistency and Bridging Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Information concerning the immunogenicity of different lots of CYD Dengue vaccine in terms of antibody levels against each of the four dengue virus serotype strains contained in the CYD dengue vaccine. [ Time Frame: 28 days post-dose 3 vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Information concerning the safety (in terms of solicited injection site and systemic reactions and unsolicited adverse events) of the CYD dengue vaccine in all subjects after each dose. [ Time Frame: 7 days and up to 6 months post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 712
Study Start Date: October 2010
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
CYD Dengue vaccine - Phase III Lot 1
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 mL, Subcutaneous (SC)
Other Name: CYD Dengue vaccine
Experimental: Group 2
CYD Dengue vaccine - Phase III Lot 2
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 mL, Subcutaneous (SC)
Other Name: CYD Dengue vaccine
Experimental: Group 3
CYD Dengue vaccine - Phase III Lot 3
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 mL, Subcutaneous (SC)
Other Name: CYD Dengue vaccine
Experimental: Group 4
CYD Dengue vaccine - Phase II Lot
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
0.5 mL, Subcutaneous (SC)
Other Name: CYD Dengue vaccine
Placebo Comparator: Group 5
NaCl 0.9%
Biological: Placebo: NaCl 0.9%
0.5 mL, Subcutaneous (SC)
Other Name: NaCl

Detailed Description:

All subjects will receive 3 doses of their assigned vaccine or placebo and will provide blood samples at defined timepoints for flavivirus status and immunogenicity assessment. Reactogenicity data will be collected in all subjects after each dose and throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 to 60 years on the day of inclusion
  • Informed consent form has been 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).

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

Temporary Contraindications:

A prospective subject must not be included in the study until the following conditions and/or symptoms are resolved:

  • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least two weeks before study vaccines Vaccination should be postponed within the timeframe for vaccination indicated in the tables of study procedures or until enrolment is ongoing at the site.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134263

Locations
Australia
Adelaide, Australia, SA 5000
Carina Heights, Australia, QLD 4152
Enoggera, Australia, QLD 4051
Heidelberg, Australia, VIC 3084
Herston, Australia, QLD 4006
Herston, Australia, QLD 4029
Subiaco, Australia, WA 6008
Westmead, Australia, NSW 2145
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01134263     History of Changes
Other Study ID Numbers: CYD17, U1111-1114-7646
Study First Received: May 27, 2010
Last Updated: July 9, 2013
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Sanofi:
Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Lot Consistency

Additional relevant MeSH terms:
Dengue
Dengue Hemorrhagic Fever
Fever
Hemorrhagic Fevers, Viral
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on April 20, 2014