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Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects

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: NCT02992418
Recruitment Status : Active, not recruiting
First Posted : December 14, 2016
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE December 14, 2016
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE December 19, 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • Antibody concentrations against pertussis antigens (pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae 2+3) 28 days after the dose of Tdap vaccine administered concomitantly or sequentially with CYD dengue vaccine [ Time Frame: Day 28 days Tdap vaccine injection ]
    Pertussis antibodies will be measured by enzyme linked immunosorbent assay (ELISA)
  • Percentage of subjects with seroprotection against diphtheria and tetanus antigens following vaccination with Tdap vaccine administered either concomitantly or sequentially with CYD Dengue vaccine [ Time Frame: Day 28 post Tdap vaccine injection ]
    Tetanus antibodies will be measured by ELISA, diphtheria antibodies will be measured by Micrometabolic Inhibition Test Toxin Neutralization assay (MIT TNA)
  • Neutralizing antibody titers against each dengue virus serotype at baseline and 28 days after the first CYD dengue injection given concomitantly or sequentially with Tdap vaccine [ Time Frame: Day 28 post first CYD dengue vaccine injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • Antibody concentrations against pertussis antigens (pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae 2+3) 28 days after the dose of Tdap vaccine administered concomitantly or sequentially with CYD dengue vaccine [ Time Frame: 28 Days post the dose of Tdap vaccine ]
    Pertussis antibodies will be measured by enzyme linked immunosorbent assay (ELISA)
  • Percentage of subjects with seroprotection against diphtheria and tetanus antigens following vaccination with Tdap vaccine administered either concomitantly or sequentially with CYD Dengue vaccine [ Time Frame: 28 Days post the dose of Tdap vaccine ]
    Tetanus antibodies will be measured by enzyme linked immunosorbent assay (ELISA), Diphtheria antibodies will be measured by Micrometabolic Inhibition Test Toxin Neutralization assay (MIT TNA)
  • Neutralizing antibody titers against each dengue virus serotype at baseline and 28 days after the first CYD dengue injection given concomitantly or sequentially with Tdap vaccine [ Time Frame: Day 28 post first CYD dengue vaccine injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)
Change History Complete list of historical versions of study NCT02992418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2018)
  • Neutralizing antibody titers against each dengue virus serotype at baseline and 28 days after the third CYD Dengue injection given concomitantly or sequentially with Tdap vaccine [ Time Frame: Day 0, and Day 28 post first and third CYD dengue vaccine injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)
  • Neutralizing antibody titers against each of the four dengue virus serotype at baseline and 28 days after the first and third CYD dengue injection given concomitantly or sequentially with Tdap vaccine [ Time Frame: Day 0 and Day 28 post first and third CYD dengue vaccine injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)
  • Antibody concentrations against tetanus, diphtheria, and pertussis antigens before and 28 days after Tdap vaccine injection [ Time Frame: Day 0 and Day 28 post Tdap vaccine injection ]
    Pertussis and tetanus antibodies will be measured by enzyme linked immunosorbent assay (ELISA) Tetanus antibodies will be measured by and by Micrometabolic Inhibition Test Toxin Neutralization assay (MIT TNA).
  • Number of participants reporting solicited injection site reactions [ Time Frame: Day 0 to Day 7 after each and any injection ]
    Solicited injection site reactions: Pain, Erythema, and Swelling
  • Number of participants reporting solicited systemic reactions [ Time Frame: Day 0 to Day 14 after each and any injection ]
    Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • Neutralizing antibody titers against each dengue virus serotype at baseline and 28 days after the third CYD Dengue injection given concomitantly or sequentially with Tdap vaccine [ Time Frame: Day 28 post the third CYD Dengue vaccine injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)
  • Antibody concentrations against Tetanus, Diphtheria, and Pertussis Antigens Before and 28 Days After the Dose of Tdap Vaccine [ Time Frame: Day O and Day 28 Post Tdap Vaccine Injection ]
    Pertussis and tetanus antibodies will be measured by enzyme linked immunosorbent assay (ELISA) Tetanus antibodies will be measured by and by Micrometabolic Inhibition Test Toxin Neutralization assay (MIT TNA).
  • 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 19 months post vaccination ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia
  • Neutralizing antibody titers against each of the four dengue virus serotype at baseline and 28 days after the first and third CYD dengue injection given concomitantly or sequentially with Tdap vaccine [ Time Frame: Day 28 post first and third CYD Dengue vaccine injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects
Official Title  ICMJE Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects Aged 9 to 60 Years in the Philippines
Brief Summary

The aim of the study is investigate the immunogenicity and safety of CYD dengue vaccine and Tdap vaccine when both vaccines are administered concomitantly or sequentially.

Primary Objectives:

  • To demonstrate the non-inferiority of the humoral immune response to the Tdap booster dose concomitantly administered with the first dose of CYD dengue vaccine as compared to sequential administration, measured 28 days after Tdap booster dose
  • To demonstrate the non-inferiority of the humoral immune response to the first dose of CYD dengue vaccine concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the first dose of CYD dengue vaccine.

Secondary Objectives:

  • To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD dengue vaccine with the first dose concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the third dose of CYD dengue vaccine.
  • To describe the humoral immune response at baseline and 28 days after the first and third doses of CYD dengue vaccine, in each and any group.
  • To describe the humoral immune response of Tdap vaccine at baseline and 28 days after concomitant administration with the first dose of CYD dengue vaccine as compared to the sequential administration, in each and any group.
  • To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each and any injection in each group.
Detailed Description

Participants are to receive CYD dengue vaccine according to a 3-dose schedule to be administered 6 months apart, with the first dose of CYD dengue vaccine administered either concomitantly or sequentially with a booster dose of the Tdap vaccine, Adacel®.

All participants are assessed for immunogenicity and safety. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dengue Fever
  • Dengue Hemorrhagic Fever
Intervention  ICMJE
  • Biological: CYD Dengue Vaccine
    0.5 mL, Subcutaneous at Month 1, 7 and 13, respectively
    Other Name: Dengvaxia®
  • Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
    0.5 mL, intramuscularly at Month 1
    Other Name: Adacel®
  • Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
    0.5 mL, intramuscularly at Day 0
    Other Name: Adacel®
Study Arms  ICMJE
  • Experimental: Concomitant Administration Group
    Participants will be administered the first dose of CYD dengue vaccine concomitantly with a dose of Tdap vaccine
    Interventions:
    • Biological: CYD Dengue Vaccine
    • Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
  • Experimental: Sequential Administration Group
    Participants will be administered the first dose of CYD dengue vaccine28 days after a dose of Tdap vaccine.
    Interventions:
    • Biological: CYD Dengue Vaccine
    • Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 17, 2019)
689
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)
688
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject aged 9 to 60 years (i.e., from the day of the 9th birthday to the day prior to the 61th birthday) on the day of inclusion
  • Subject in good health, based on medical history and physical examination
  • Informed consent form (ICF) or assent form (AF) has been signed and dated by the subject (based on local regulations), and/or 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)
  • For subject aged 9 to 11 years: known (documented) receipt of at least 4 previous doses of diphtheria toxoid, tetanus toxoid and acellular pertussis-containing (DTaP) vaccines, with the last dose not within the last 5 years prior to enrolment OR For subject aged at least 12 years: known (documented or self-reported) receipt of at least 3 previous doses of diphtheria toxoid, tetanus toxoid, and whole cell pertussis-containing (DTwP) vaccines, with the last dose not within the last 5 years prior to enrolment
  • Subject (or subject and parent[s]/legally acceptable representatives) 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 or 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 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
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination
  • Previous vaccination against dengue disease with the trial CYD dengue vaccine
  • Receipt of immune globulins, 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 (including HIV infection with impaired immune function); or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine
  • 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
  • Thrombocytopenia, contraindicating intramuscular vaccination
  • Bleeding disorder or receipt of anticoagulants within 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator
  • Deprived of freedom by 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
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
  • Identified as an Investigator or employee of the Investigator 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
  • Self-reported Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infection
  • Personal history of Guillain-Barré syndrome.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02992418
Other Study ID Numbers  ICMJE CYD66
U1111-1161-3294 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur SA
PRS Account Sanofi
Verification Date September 2019

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