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

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: NCT02979535
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of this study is to investigate the immunogenicity and safety of CYD dengue vaccine and Cervarix when administered concomitantly or sequentially in healthy female subjects aged 9-14 years of age.

Primary objectives:

  • To demonstrate that the humoral immune response (in terms of geometric mean titers [GMTs]) to Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of GMTs) after sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix
  • To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after concomitant administration with Cervarix is non-inferior to the humoral immune response (in terms of GMTs) to the CYD dengue vaccine after sequential administration with Cervarix 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 Cervarix after concomitant administration with the CYD dengue vaccine is non-inferior to the humoral immune response (in terms of seroconversion) to Cervarix sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Cervarix
  • To describe the humoral immune response to Cervarix at baseline and after each dose of Cervarix 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 Cervarix and 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 Bivalent [Types16 and 18] Vaccine, Recombinant Biological: Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant Phase 3

Detailed Description:

Participants were to receive 3 doses of the CYD dengue vaccine and 2 doses of Cervarix 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 and be assessed for CYD immunogenicity and human papilloma virus (HPV) immunogenicity. Dengue unexposed participants (seronegative for dengue before vaccination) will not receive the third CYD dengue vaccine injection, but will be followed for safety up to 6 months after the last injection.

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. All participants will be included in the assessment of safety up to 6 months after the last injection.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 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 Cervarix® in Healthy Female Subjects Aged 9 to 14 Years in Mexico
Actual Study Start Date : November 16, 2016
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : March 25, 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 CYD dengue vaccine and 2 doses of Cervarix concomitantly with the 2 first doses of CYD dengue vaccine.
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous at Day 0, Months 6 and 12
Other Name: Dengvaxia®

Biological: Human Papillomavirus Bivalent [Types16 and 18] Vaccine, Recombinant
0.5 mL, intramuscular at Day 0 and Month 6
Other Name: Cervarix®

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

Biological: Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant
0.5 mL, intramuscular at Day 0 and Month 6
Other Name: Cervarix®




Primary Outcome Measures :
  1. Antibody levels against each Cervarix HPV bivalent antigen after the last dose of Cervarix in previously dengue exposed participants [ Time Frame: Day 28 after the last Cervarix injection ]
    HPV-16 and HPV-18 antibodies will be measured by enzyme linked immunosorbent assay (ELISA)

  2. Neutralizing antibody titers against each dengue virus serotype after the last CYD dengue vaccine injection in previously dengue exposed participants [ 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. Antibody levels against each HPV antigen after each dose of Cervarix in previously dengue exposed participants [ Time Frame: 28 days after each Cervarix injection ]
    HPV-16 and HPV-18 antibodies will be measured by ELISA

  2. Percentage of participants with seroconversion against each Cervarix HPV antigen after each dose of Cervarix in previously dengue exposed participants [ Time Frame: 28 days after each Cervarix injection ]
    HPV-16 and HPV-18 antibodies will be measured by ELISA. Seroconversion is defined as changing serostatus from seronegative at baseline to seropositive (> lower limit of quantitation of the assay) or ≥ 4-fold rise in antibody titer if seropositive at baseline

  3. Neutralizing antibody titers against each dengue virus serotype after each CYD dengue vaccine injection in previously dengue exposed participants [ Time Frame: 28 days after each CYD dengue vaccine injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured by dengue PRNT50

  4. Neutralizing antibody titers above pre-defined threshold against each and against at least 1, 2, 3, or 4 dengue virus serotypes after each CYD dengue vaccine injection in previously dengue exposed participants [ Time Frame: 28 days after each CYD dengue vaccine injection ]
    Neutralizing antibody levels against each dengue virus serotype will be measured by dengue PRNT50

  5. Number of participants reporting solicited injection site reactions [ Time Frame: 7 days after each vaccine injection ]
    Solicited injection site reactions: Pain, Erythema, and Swelling

  6. Number of participants reporting solicited systemic reactions [ Time Frame: 14 days after each vaccine injection ]
    Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject aged 9 to 14 years (i.e., from the day of the 9th birthday to the day prior to the 15th 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): NCT02979535


Locations
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Mexico
Mexico City, Mexico
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: NCT02979535     History of Changes
Other Study ID Numbers: CYD71
U1111-1161-3455 ( Other Identifier: WHO )
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 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 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue Fever
Dengue Hemorrhagic Fever
Human Papillomavirus Disease
CYD Dengue Vaccine
Dengvaxia®
Cervarix®
Additional relevant MeSH terms:
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Severe Dengue
Dengue
Hemorrhagic Fevers, Viral
Fever
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs