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Trial record 3 of 167 for:    dengue

Immunogenicity and Safety of 3-Dose and Booster Dose of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age

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.
ClinicalTrials.gov Identifier: NCT02628444
Recruitment Status : Active, not recruiting
First Posted : December 11, 2015
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of the study is to assess the safety of the primary series vaccine schedules and the booster vaccination

Primary Objectives:

  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.
  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post final vaccination.
  • To demonstrate the non-inferiority of the immune response elicited against each dengue serotype 28 days after administration of a single booster dose of tetravalent CYD vaccine

Secondary Objectives:

  • To demonstrate the superiority of the immune response elicited by tetravalent CYD vaccine given as a 2 dose schedule (Placebo 1/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.
  • To demonstrate the superiority of the immune response elicited by tetravalent CYD vaccine given as a 1 dose schedule (Placebo 2/CYD Dengue vaccine group) compared to the immune response elicited by CYD vaccine given as a 3 dose schedule (CYD Dengue vaccine group) 28 days post-final vaccination.
  • To describe the neutralizing antibody levels of each dengue serotype at 28 days post Dose 3 to the Ab levels immediately before receiving booster injection in all 3 CYD vaccination groups.
  • To describe the neutralizing antibody levels of each dengue serotype at 28 days post-dose 2 and 28 days post-dose 3 from CYD Dengue vaccine group in a primary series schedule.
  • To demonstrate the superiority of the immune response elicited against each dengue serotype 28 days after administration of a single booster dose of tetravalent CYD vaccine.
  • To evaluate the safety profile of CYD vaccine after each and any injection

Condition or disease Intervention/treatment Phase
Dengue Fever Dengue Hemorrhagic Fever Biological: CYD Dengue Vaccine Biological: NaCl + CYD Dengue Vaccine Phase 2

Detailed Description:
Healthy subjects between age 9 and 50 year will receive in various schedules of CYD vaccine and placebo administration over a 12-month period. They will be further randomized to receive a single booster vaccination of CYD vaccine at either 12 months or 24 months following the last primary series injection.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1 , 2 , or 3 Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years After the Last Primary Dose in Healthy Subjects 9 to 50 Years of Age in Colombia and the Philippines
Actual Study Start Date : May 2, 2016
Estimated Primary Completion Date : March 27, 2020
Estimated Study Completion Date : March 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CYD Dengue vaccine group
Participants randomized to receive 3 doses of CYD Dengue vaccine
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively
Experimental: Placebo 1/CYD Dengue vaccine group
Participants randomized to receive a placebo followed by 2 doses of CYD Dengue vaccine
Biological: NaCl + CYD Dengue Vaccine
0.5 mL, Subcutaneous at Day 0 (placebo), 6 and 12 months (CYD), respectively
Experimental: Placebo 2/CYD Dengue vaccine group
Participants randomized to receive 2 doses of placebo followed by 1 dose of CYD Dengue vaccine
Biological: NaCl + CYD Dengue Vaccine
0.5 mL, Subcutaneous at Day 0 and Month 6 (placebo), 12 months (CYD), respectively



Primary Outcome Measures :
  1. Summary of Neutralizing antibody titers against each dengue virus serotype 28 days after the last CYD dengue vaccine injection in each Group primary series schedules [ Time Frame: 28 days after the last CYD dengue vaccine ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).

  2. Summary of Neutralizing antibody titers against each dengue virus serotype 28 days post booster dose (Year 1 and Year 2, respectively, for each group tested in STAGE II) [ Time Frame: 28 days after the booster vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).


Secondary Outcome Measures :
  1. Number of subjects with seroconversion 28 days after injection for each of the 4 parental dengue virus strains of CYD dengue vaccine [ Time Frame: 28 Days post each vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT). Seroconversion is percentage of subjects with either a pre booster titer < 10 (1/dil) and a post booster titer ≥ 40 (1/dil), or a pre booster titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post booster titer

  2. Summary of neutralizing antibody titers against each dengue virus serotype immediately prior to booster dose and post booster in all 3 CYD vaccination groups [ Time Frame: 28 days after the booster vaccination ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue plaque reduction neutralization test (PRNT).

  3. Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial [ Time Frame: Day 0 up to 2 years post vaccination ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 9 to 50 years on the day of enrollment
  • Subject in good health, based on medical history and physical examination
  • Assent form or informed consent form (ICF) has been signed and dated by the subject (based on local regulations), and ICF has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)
  • Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using 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)
  • Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device or medical procedure
  • Self-reported 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 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
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination
  • Previous vaccination against dengue disease with either the trial vaccine or another vaccine
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that, based on investigator's judgment, may interfere with the subject´s ability to comply with trial procedures.
  • Identified as a site employee of the Investigator, 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 employees or the Investigator
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628444


Locations
Colombia
Barranquilla, Colombia
Cali, Colombia
Medellin, Colombia
Philippines
Manila, Philippines
Muntinlupa City, Philippines
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02628444     History of Changes
Other Study ID Numbers: CYD65
U1111-1161-3242 ( Other Identifier: WHO )
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue Fever
Dengue virus
Dengue Hemorrhagic Fever
CYD Dengue Vaccine

Additional relevant MeSH terms:
Dengue
Severe Dengue
Fever
Hemorrhagic Fevers, Viral
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs