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Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents

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: NCT02199691
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE July 23, 2014
First Posted Date  ICMJE July 24, 2014
Last Update Posted Date February 9, 2018
Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
Levels of Antibody titers against meningococcal serogroups A, C, Y, and W135 measured by serum bactericidal assay using human complement (hSBA) for Group 1 and Group 3 [ Time Frame: Day 0 (pre-vaccination) and 30 days post-vaccination ]
Immunogenicity endpoints on serum bactericidal antibody titers for meningococcal serogroups A, C, Y, and W135 measured by serum bactericidal assay using human complement (hSBA)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02199691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2014)
  • Levels of Antibody titers against meningococcal serogroups A, C, Y, and W135 measured by serum bactericidal assay using human complement (hSBA) for Group 1 and Group 2 [ Time Frame: Day 0 (pre-vaccination) and 30 days post-vaccination ]
    Immunogenicity endpoints on serum bactericidal antibody titers for meningococcal serogroups A, C, Y, and W135 measured by serum bactericidal assay using human complement (hSBA)
  • Levels of Anti-pertussis antibody concentrations for Participants in Group 3 and Group 4 [ Time Frame: 30 days post-vaccination ]
    Anti-pertussis antibody concentrations (Pertussis toxoid [PT] and Filamentous hemagglutinin [FHA], Pertactin [PRN], Fimbriae types 2 and 3 [FIM]) will be measured by enzyme-linked immunosorbent assay (ELISA)
  • Levels of Anti-tetanus and anti-diphtheria antibody concentrations for Participants in Group 3 and Group 4 [ Time Frame: 30 days post-vaccination ]
    Diphtheria concentration will be measured by a toxin neutralization test; Tetanus concentration will be measured by an enzyme-linked immunosorbent assay (ELISA).
  • Levels of Anti-Human Papillomavirus (HPV) antibody concentrations (types 6, 11, 16, and 18) for Group 3 and Group 4 [ Time Frame: Day 0 and 30 days after the third dose of HPV vaccine ]
  • Percentage of participants reporting solicited reactions, unsolicited adverse events, and serious adverse events occurring throughout the trial [ Time Frame: Day 0 up to Day 210 post-vaccination ]
    Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
Official Title  ICMJE A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
Brief Summary

The purpose of this trial is to evaluate the immunogenicity and safety of MenACYW conjugate vaccine compared to those of a licensed product, MENVEO vaccine and also evaluate MenACYW conjugate vaccine when given alone compared to when given with Tdap vaccine and HPV vaccine.

Primary objective:

  • To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine when MenACYW conjugate vaccine is given alone compared to those when MENVEO vaccine is given alone.

Secondary objective:

  • To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine, when MenACYW conjugate vaccine is given concomitantly with Tdap and HPV vaccines, compared to those when it is given alone
  • To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap vaccine is given concomitantly with MenACYW conjugate vaccine and HPV vaccine, compared to those when Tdap vaccine is given with HPV vaccine only

Observational objective:

  • To describe the safety profile of MenACYW conjugate vaccine, compared to that of the licensed vaccine MENVEO®, and when MenACYW conjugate vaccine is given with Tdap and HPV vaccines.
Detailed Description Participants will receive their assigned vaccine and will be evaluated for immunogenicity and safety. The duration of participation in the trial will be approximately 180 to 210 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections
Intervention  ICMJE
  • Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine
    0.5 mL, Intramuscular (IM)
    Other Name: MenACYW conjugate vaccine
  • Biological: Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197Conjugate Vaccine
    0.5 mL, IM
    Other Name: MENVEO®
  • Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
    0.5 mL, IM
    Other Name: Adacel® (Tdap)
  • Biological: GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
    0.5 mL, IM
    Other Name: GARDASIL® (HPV)
Study Arms  ICMJE
  • Experimental: Study Group 1
    Participants will receive MenACYW conjugate vaccine
    Intervention: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine
  • Active Comparator: Study Group 2
    Participants will receive MENVEO® vaccine
    Intervention: Biological: Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197Conjugate Vaccine
  • Experimental: Study Group 3
    Participants will receive MenACYW conjugate vaccine, Tdap and HPV
    Interventions:
    • Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
    • Biological: GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
    • Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine
  • Active Comparator: Study Group 4
    Participants will receive Tdap and HPV
    Interventions:
    • Biological: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
    • Biological: GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
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 Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2018)
1715
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2014)
1700
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 10 to 17 years on the day of inclusion
  • Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative
  • Assent form has been signed and dated by the subject
  • Subject and parent legally acceptable representative are able to attend all scheduled visits and 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 and until at least 4 weeks after the last vaccination)
  • Participation in the 4 weeks preceding the first trial vaccination(s) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination(s) or planned receipt of any vaccine in the 4 weeks prior to or following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after any study vaccines. This exception includes monovalent influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against meningococcal disease with either the trial vaccine or any mono- or polyvalent polysaccharide or conjugate meningococcal vaccine containing A, C, W, or Y antigens
  • History of vaccination with any tetanus, diphtheria, or pertussis vaccine within the previous 4 years
  • Previous HPV vaccination
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Known 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)
  • History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
  • At high risk for meningococcal infection during the trial (i.e., subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
  • 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, including encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine
  • Personal history of Guillain-Barré syndrome
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination
  • Verbal report of 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
  • Chronic illness (e.g., HIV hepatitis B, hepatitis C) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02199691
Other Study ID Numbers  ICMJE MET50
U1111-1143-8537 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
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 Inc.
PRS Account Sanofi
Verification Date February 2018

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