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Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Gardasil®

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ClinicalTrials.gov Identifier: NCT02993757
Recruitment Status : Active, not recruiting
First Posted : December 15, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of the study is to assess the safety and immunogenicity of the CYD dengue vaccine when administered concomitantly or sequentially with Gardasil® (Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant).

Primary objectives:

  • To demonstrate that the humoral immune response (in terms of geometric mean titers[GMTs]) to Gardasil after concomitant administration is non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil.
  • To demonstrate that the humoral immune response to the CYD dengue vaccine after concomitant administration is non-inferior to sequential administration with Gardasil measured 28 days after the last dose of the CYD dengue vaccine.

Secondary Objectives:

  • To demonstrate that the humoral immune response (in terms of seroconversion) to Gardasil after concomitant administration is non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil
  • To describe the humoral immune response to Gardasil at baseline and after each dose of Gardasil in each and any group
  • To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine in each and any group
  • To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose in each group.

Condition or disease Intervention/treatment Phase
Dengue Fever Dengue Hemorrhagic Fever Human Papillomavirus Disease Biological: CYD Dengue Vaccine Biological: Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant. Phase 3

Detailed Description:

Participants were to receive 3 doses of CYD dengue vaccine and 2 doses of Gardasil administered either concomitantly or sequentially.

Due to a protocol amendment, only previously dengue exposed participants (seropositive for dengue before vaccination) will be eligible to complete the vaccination schedule. Dengue unexposed participants (seronegative for dengue before vaccination) will not receive any additional CYD dengue vaccine injections, but will be followed for safety up to 6 months after the last injection.

All participants will be 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 : 528 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 Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : December 24, 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: Concomitant Administration Group
Subjects will receive 3 doses of the CYD dengue vaccine and 2 doses of Gardasil® (Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant) concomitantly to the 2 first doses of CYD dengue vaccine.
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous at Day 0, Month 6 and 12, respectively
Other Name: Dengvaxia®

Biological: Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant.
0.5 mL, intramuscular at Day 0 and Month 6, respectively
Other Name: Gardasil®

Experimental: Sequential Administration Group
Subjects will receive 3 doses of the CYD dengue vaccine and 2 doses of Gardasil sequentially to the 2 first doses of CYD dengue vaccine
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous at Month 1, 7 and 13, respectively
Other Name: Dengvaxia®

Biological: Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant.
0.5 mL, intramuscular at Day 0 and Month 6, respectively
Other Name: Gardasil®




Primary Outcome Measures :
  1. Antibody levels against each Gardasil human papillomavirus quadrivalent (HPV) antigen (HPV 6, HPV 11, HPV 16, and HPV 18) 28 days after the last dose of Gardasil following either a concomitant or sequential administration with CYD dengue vaccine [ Time Frame: Day 28 after the last Gardasil injection ]
    HPV 6, HPV 11, HPV 16, and HPV 18 antibodies will be measured by the competitive Luminex immunoassay.

  2. Neutralizing antibody titers against each of the four dengue virus serotype at baseline and 28 days after the last CYD dengue vaccine injection. [ Time Frame: Day 28 after the last 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. Percentage of participants with seroconversion against each Gardasil HPV antigen (HPV 6, HPV 11, HPV 16, HPV 18) after the last dose of Gardasil [ Time Frame: Day 28 after the last Gardasil injection ]
    HPV 6, 11, 16 and 18 antibodies will be measured by the competitive Luminex immunoassay

  2. Neutralizing antibody titers against each of the four dengue virus serotype at baseline and 28 days after each CYD dengue vaccine injection [ Time Frame: Day 28 after each 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 levels against each Gardasil HPV antigen (HPV 6, HPV 11, HPV 16, and HPV 18) 28 days after each dose of Gardasil following either a concomitant or Sequential administration with CYD dengue vaccine [ Time Frame: Day 28 after each Gardasil injection ]
    HPV 6, HPV 11, HPV 16, and HPV 18 antibodies will be measured by the competitive Luminex immunoassay.

  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 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



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Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject aged 9 to 13 years (i.e., from the day of the 9th birthday to the day prior to the 14th birthday) on the day of inclusion
  • 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)
  • Subject (or subject and parent[s] or another legally acceptable representative) is (are) 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 pre-menarche, 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 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 vaccine
  • Previous vaccination against HPV disease with either the trial vaccine or another vaccine
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • History of HPV infection, confirmed either clinically, serologically, or microbiologically as reported by subject or parent(s) or another legally acceptable representative
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  • Thrombocytopenia, contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • 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
  • 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 Hepatitis B, Hepatitis C infection.

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): NCT02993757


Locations
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Malaysia
Sanofi Pasteur Investigational Site 004
Klang, Malaysia, 42000
Sanofi Pasteur Investigational Site 005
Kuala Lumpur, Malaysia, 50590
Sanofi Pasteur Investigational Site 001
Kuala Lumpur, Malaysia, 59100
Sanofi Pasteur Investigational Site 003
Kuantan, Malaysia, 25100
Sanofi Pasteur Investigational Site 002
Sibu, Malaysia, 96000
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: NCT02993757     History of Changes
Other Study ID Numbers: CYD67
U1111-1161-3376 ( Other Identifier: WHO )
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
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 clinicalstudydatarequest.com. While making information available at Sanofi continues to protect the privacy of the participants in 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

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue Fever
Dengue Hemorrhagic Fever
Human Papillomavirus Disease
CYD Dengue Vaccine
Dengvaxia®
Gardasil®

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