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

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ClinicalTrials.gov Identifier: NCT02992418
Recruitment Status : Active, not recruiting
First Posted : December 14, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

Condition or disease Intervention/treatment Phase
Dengue Fever Dengue Hemorrhagic Fever Biological: CYD Dengue Vaccine Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 688 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : December 20, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Concomitant Administration Group
Participants will be administered the first dose of CYD dengue vaccine concomitantly with a dose of Tdap vaccine
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®

Experimental: Sequential Administration Group
Participants will be administered the first dose of CYD dengue vaccine28 days after a dose of Tdap vaccine.
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 Day 0
Other Name: Adacel®




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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).

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02992418


Locations
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Philippines
Muntinlupa, Alabang, Philippines
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur SA

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02992418     History of Changes
Other Study ID Numbers: CYD66
U1111-1161-3294 ( Other Identifier: WHO )
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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