Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01550289
First received: March 7, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects.

Primary Objectives:

  • To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects.
  • To describe the safety of the CYD dengue vaccine after each dose in all subjects.

Secondary Objective:

  • To detect symptomatic dengue cases occurring at any time in the trial.

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

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: Immunogenicity and Safety of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Information on the antibody levels against each of the four parental dengue virus strains of CYD dengue vaccine constructs determined by a dengue plaque reduction neutralization test (PRNT) [ Time Frame: 28 Days after each dose ] [ Designated as safety issue: No ]
  • Information concerning the safety in terms of solicited injection site and systemic reaction, serious adverse events (SAEs) and SAE of special interest following vaccination with CYD dengue vaccine [ Time Frame: up to 18 months post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Information on the symptomatic virologically confirmed dengue cases occurring > 28 days after Dose 3 during the active phase. [ Time Frame: Up to 18 months post-vaccination 1 ] [ Designated as safety issue: No ]
    The Symptomatic virologically confirmed dengue cases occurring during the active phase will be in terms of (i) Acute febrile illness (i.e., temperature ≥ 38°C on at least 2 consecutive days) and (ii) Virologically confirmed.


Enrollment: 189
Study Start Date: March 2012
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: CYD dengue vaccine
Subjects will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively.
Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
0.5 mL, Subcutaneous
Other Name: CYD Dengue vaccine
Placebo Comparator: Group 2: Placebo
Subjects will receive a dose of placebo at 0, 6, and 12 months, respectively
Biological: Placebo: NaCl 0.9% solution
0.5 ml, Subcutaneous

Detailed Description:

Participants will receive 3 doses of their randomized treatment (vaccine or placebo). Flavivirus status will be determined at baseline (before the first dose) and the vaccine immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will be collected in all subjects after each dose. Serious adverse events and adverse events of special interest will be collected throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 to 45 years on the day of inclusion
  • Informed consent form has been signed and dated by the subject (and by an independent witness, if applicable)
  • Subject is able to attend all scheduled visits and to comply with all trial procedures
  • Subject in good health, based on medical history and physical examination

Exclusion Criteria:

  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
  • 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
  • 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)
  • Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C reported by the subject
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Identified as an Investigator or employee of the Investigator or study center, with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550289

Locations
India
Bangalore, Karnataka, India, 560054
Ludhiana, Punjab, India, 141008
Kolkata, West Bengal, India, 700073
New Delhi, India, 110002
Pune, India, 411018
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur India Pvt Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01550289     History of Changes
Other Study ID Numbers: CYD47, UTN: U1111-1114-7909
Study First Received: March 7, 2012
Last Updated: April 8, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by Sanofi:
Dengue Fever
Dengue Hemorrhagic Fever
CYD Dengue Vaccine
Dengue Virus
Flavivirus

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

ClinicalTrials.gov processed this record on September 30, 2014