Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
2 other identifiers
interventional
1,715
2 countries
36
Brief Summary
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the United States (US). This study also evaluated the immunogenicity and safety of MenACYW Conjugate vaccine when given alone compared to when given concomitantly with tetanus, diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine. Primary objective:
- To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was given alone. Secondary objective:
- To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines, compared to those when it was given alone.
- To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared to those when Tdap vaccine was given with HPV vaccine only.
- To evaluate the antibody responses to the antigens present in HPV vaccine after the 3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine is given with Tdap 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 was given with Tdap and HPV vaccines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2014
Shorter than P25 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 22, 2014
CompletedFirst Submitted
Initial submission to the registry
July 23, 2014
CompletedFirst Posted
Study publicly available on registry
July 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2015
CompletedResults Posted
Study results publicly available
June 9, 2020
CompletedApril 4, 2022
March 1, 2022
1.2 years
July 23, 2014
May 19, 2020
March 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers \>= 1:8. Data for this outcome measure was not planned to be collected and analyzed for Group 4:Tdap+HPV.
Day 30 (post-vaccination)
Secondary Outcomes (7)
Percentage of Participants Achieving hSBA Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines
Day 30 (post-vaccination on Day 0)
Geometric Mean Concentrations (GMCs) of PT, FHA, PRN, and FIM Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
Day 30 (post-vaccination on Day 0)
Percentage of Participants Achieving Anti-Tetanus and Anti-Diphtheria Concentrations >= 1.0 International Unit (IU)/mL Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
Day 30 (post-vaccination on Day 0)
Percentage of Participants Achieving Seroconversion for Anti-HPV6, HPV11, HPV16, and HPV18 Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
Day 210 (post-vaccination on Day 0)
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine or MENVEO® Vaccine at Day 0: Group 1 and Group 2
Within 7 days after vaccines injections at Day 0
- +2 more secondary outcomes
Study Arms (4)
Group 1: MenACYW Conjugate Vaccine
EXPERIMENTALHealthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Group 2: MENVEO® Vaccine
ACTIVE COMPARATORHealthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
EXPERIMENTALHealthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
Group 4: Tdap+HPV
ACTIVE COMPARATORHealthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
Interventions
0.5 mL, IM
0.5 mL, IM
0.5 mL, IM
0.5 milliliter (mL), Intramuscular (IM)
Eligibility Criteria
You may qualify if:
- Informed consent form was signed and dated by the parent(s) or another legally acceptable representative.
- Assent form was signed and dated by the participant.
- Participant and parent legally acceptable representative were able to attend all scheduled visits and comply with all trial procedures.
You may not qualify if:
- Participant was 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 included 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 human papilloma virus (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., participants with persistent complement deficiency, with anatomic or functional asplenia, or participants 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.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Birmingham, Alabama, 35235, United States
Unknown Facility
Huntsville, Alabama, 35802, United States
Unknown Facility
Downey, California, 90241, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Miami Beach, Florida, 33141, United States
Unknown Facility
Wichita, Kansas, 67205, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Nicholasville, Kentucky, 40356, United States
Unknown Facility
Columbia, Maryland, 21075, United States
Unknown Facility
Lincoln, Nebraska, 68504, United States
Unknown Facility
Lincoln, Nebraska, 68505, United States
Unknown Facility
Lincoln, Nebraska, 68516, United States
Unknown Facility
Cleveland, Ohio, 44121, United States
Unknown Facility
Dayton, Ohio, 45414, United States
Unknown Facility
Norman, Oklahoma, 73069, United States
Unknown Facility
Erie, Pennsylvania, 16505, United States
Unknown Facility
Charleston, South Carolina, 29414, United States
Unknown Facility
Kingsport, Tennessee, 37660, United States
Unknown Facility
Tullahoma, Tennessee, 37388, United States
Unknown Facility
Layton, Utah, 84041, United States
Unknown Facility
Orem, Utah, 84057, United States
Unknown Facility
Payson, Utah, 84651, United States
Unknown Facility
Provo, Utah, 84064, United States
Unknown Facility
Roy, Utah, 84067, United States
Unknown Facility
Salt Lake City, Utah, 84109, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Unknown Facility
South Jordan, Utah, 84095, United States
Unknown Facility
Spanish Fork, Utah, 84660, United States
Unknown Facility
Syracuse, Utah, 84075, United States
Unknown Facility
West Haven, Utah, 84401, United States
Unknown Facility
West Jordan, Utah, 84088, United States
Unknown Facility
Charlottesville, Virginia, 22902, United States
Unknown Facility
Midlothian, Virginia, 23113, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Spokane, Washington, 99218, United States
Unknown Facility
San Juan, PR, 00918, Puerto Rico
Related Publications (1)
Chang LJ, Hedrick J, Christensen S, Pan J, Jordanov E, Dhingra MS. A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States. Vaccine. 2020 Apr 23;38(19):3560-3569. doi: 10.1016/j.vaccine.2020.03.017. Epub 2020 Mar 21.
PMID: 32209248RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2014
First Posted
July 24, 2014
Study Start
July 22, 2014
Primary Completion
October 2, 2015
Study Completion
October 2, 2015
Last Updated
April 4, 2022
Results First Posted
June 9, 2020
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org