We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550289
First Posted: March 9, 2012
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
March 7, 2012
March 9, 2012
September 14, 2016
November 3, 2016
December 28, 2016
March 2012
December 2013   (Final data collection date for primary outcome measure)
  • Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
  • Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
  • Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
  • Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
  • Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo [ Time Frame: Day 0 up to Day 14 post each injection ]
    Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.
  • 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 ]
  • Information concerning the safety in terms of solicited injection site and systemic reaction, serious adverse events and SAE of special interest following vaccination with CYD dengue vaccine [ Time Frame: up to 18 months post-vaccination ]
Complete list of historical versions of study NCT01550289 on ClinicalTrials.gov Archive Site
  • Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
  • Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
  • Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
  • Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
  • Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
  • Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
  • Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
  • Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) ]
    Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
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 ]
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.
Not Provided
Not Provided
 
Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India
Immunogenicity and Safety of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India.

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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Dengue
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
    0.5 mL, Subcutaneous
    Other Name: CYD Dengue vaccine
  • Biological: Placebo: NaCl 0.9% solution
    0.5 ml, Subcutaneous
  • Experimental: Group 1: CYD dengue vaccine
    Subjects will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively.
    Intervention: Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
  • Placebo Comparator: Group 2: Placebo
    Subjects will receive a dose of placebo at 0, 6, and 12 months, respectively
    Intervention: Biological: Placebo: NaCl 0.9% solution
Dubey AP, Agarkhedkar S, Chhatwal J, Narayan A, Ganguly S, Wartel TA, Bouckenooghe A, Menezes J. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial. Hum Vaccin Immunother. 2016;12(2):512-8. doi: 10.1080/21645515.2015.1076598.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
February 2014
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01550289
CYD47
UTN: U1111-1114-7909 ( Other Identifier: WHO )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi.
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur India Pvt Ltd
Sanofi
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP