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

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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 )

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.

Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Meningitis Meningococcal Infections Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine Biological: Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197Conjugate Vaccine 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 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1715 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
Study Start Date : July 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group 1
Participants will receive MenACYW conjugate vaccine
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine
0.5 mL, Intramuscular (IM)
Other Name: MenACYW conjugate vaccine

Active Comparator: Study Group 2
Participants will receive MENVEO® vaccine
Biological: Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197Conjugate Vaccine
0.5 mL, IM
Other Name: MENVEO®

Experimental: Study Group 3
Participants will receive MenACYW conjugate vaccine, Tdap and HPV
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)

Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine
0.5 mL, Intramuscular (IM)
Other Name: MenACYW conjugate vaccine

Active Comparator: Study Group 4
Participants will receive Tdap and HPV
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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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).

  4. 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 ]
  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02199691


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Locations
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United States, Alabama
Birmingham, Alabama, United States, 35235
Huntsville, Alabama, United States, 35802
United States, California
Downey, California, United States, 90241
San Diego, California, United States, 92103
United States, Florida
Miami Beach, Florida, United States, 33141
United States, Kansas
Wichita, Kansas, United States, 67205
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Nicholasville, Kentucky, United States, 40356
United States, Maryland
Columbia, Maryland, United States, 21075
United States, Nebraska
Lincoln, Nebraska, United States, 68504
Lincoln, Nebraska, United States, 68505
Lincoln, Nebraska, United States, 68516
United States, Ohio
Cleveland, Ohio, United States, 44121
Dayton, Ohio, United States, 45414
United States, Oklahoma
Norman, Oklahoma, United States, 73069
United States, Pennsylvania
Erie, Pennsylvania, United States, 16505
United States, South Carolina
Charleston, South Carolina, United States, 29414
United States, Tennessee
Kingsport, Tennessee, United States, 37660
Tullahoma, Tennessee, United States, 37388
United States, Utah
Layton, Utah, United States, 84041
Orem, Utah, United States, 84057
Payson, Utah, United States, 84651
Provo, Utah, United States, 84064
Roy, Utah, United States, 84067
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84124
South Jordan, Utah, United States, 84095
Spanish Fork, Utah, United States, 84660
Syracuse, Utah, United States, 84075
West Haven, Utah, United States, 84401
West Jordan, Utah, United States, 84088
United States, Virginia
Charlottesville, Virginia, United States, 22902
Midlothian, Virginia, United States, 23113
United States, Washington
Spokane, Washington, United States, 99204
Spokane, Washington, United States, 99218
Puerto Rico
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02199691     History of Changes
Other Study ID Numbers: MET50
U1111-1143-8537 ( Other Identifier: WHO )
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
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.
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Meningitis
MenACYW conjugate vaccine
MENVEO vaccine
Adacel®
GARDASIL®
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningococcal Infections
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs