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Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers

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ClinicalTrials.gov Identifier: NCT02955797
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The purpose of the study is to evaluate the quadrivalent meningococcal conjugate vaccine when used as a single-dose toddler vaccine in individuals who are either meningococcal vaccine naïve or have received one or more doses of monovalent meningococcal C (MenC) vaccines during infancy.

Primary Objectives:

  • To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy
  • To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers

Secondary Objectives:

  • To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy
  • To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in meningococcal vaccine naïve toddlers
  • To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who received monovalent MenC vaccination during infancy.

Observational Objective:

  • To evaluate the safety profile of MenACYW conjugate vaccine and Nimenrix®.

Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Meningitis Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine Biological: Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine Phase 3

Detailed Description:
Healthy toddlers aged 12 to 23 months will be enrolled and randomized depending on the meningococcal background to receive either MenACYW conjugate vaccine or Nimenrix®. They will be assessed for immunogenicity assessment at baseline (pre-vaccination) and post-vaccination. Safety information will be collected post-vaccination and through the entire study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 918 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age.
Actual Study Start Date : February 22, 2017
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : October 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Arm Intervention/treatment
Experimental: MenACYW conjugate vaccine (Group 1)
Meningococcal vaccine-naïve participant randomized to receive MenACYW conjugate vaccine
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: MenACYW conjugate vaccine

Experimental: Nimenrix® vaccine (Group 2)
Meningococcal vaccine-naïve participant randomized to receive Nimenrix® vaccine
Biological: Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine
0.5 mL, Intramuscular
Other Name: Nimenrix®

Experimental: MenACYW conjugate vaccine (Group 3)
Meningococcal C conjugate vaccine-primed participant randomized to receive MenACYW conjugate vaccine
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: MenACYW conjugate vaccine

Experimental: Nimenrix® vaccine (Group 4)
Meningococcal C vaccine conjugate-primed participant randomized to receive Nimenrix® vaccine
Biological: Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine
0.5 mL, Intramuscular
Other Name: Nimenrix®




Primary Outcome Measures :
  1. Percentage of participants with antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W post-vaccination with either MenACYW conjugate vaccine or Nimenrix® vaccine. [ Time Frame: Day 30 Post-vaccination ]
    Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement (hSBA)

  2. Percentage of participants with antibody titers.≥ 1:8 against meningococcal serogroups A, C, Y, and W post vaccination with MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers [ Time Frame: Day 30 Post-vaccination ]
    Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement


Secondary Outcome Measures :
  1. Geometric Mean Titers against meningococcal serogroups A, C, Y, and W before and after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy [ Time Frame: Day 0 (pre-vaccination) and Day 30 Post-vaccination ]
    Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement

  2. Geometric Mean Titers against meningococcal serogroups A, C, Y, and W before and after vaccination with MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers [ Time Frame: Day 0 (pre-vaccination) and Day 30 Post-vaccination ]
    Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement

  3. Geometric Mean Titers against meningococcal serogroups A, C, Y, and W before and after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who received monovalent MenC vaccination during infancy [ Time Frame: Day 0 (pre vaccination) and Day 30 Post vaccination ]
    Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement

  4. Number of Participants with Solicited Reactions, Unsolicited Adverse Events and Serious Adverse Events Following Vaccination with Either MenACYW Conjugate Vaccine or Nimenrix® Vaccine [ Time Frame: Day 0 up to Day 45 post-vaccination ]
    Solicited injection-site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events, including serious adverse events throughout the study



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 12 to 23 months on the day of the first study visit
  • Subjects have received all recommended standard-of-care non-meningococcal vaccinations according to his/her age as per local regulations
  • Informed consent form (ICF) has been signed and dated by the parent/legally acceptable representative
  • Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
  • Covered by health insurance if required by local regulations
  • Subjects have not received any meningococcal vaccine in the second year of life (i.e., from 12 months of age)
  • For Inclusion in Groups 1 and 2: Subjects must not have received any vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine)
  • For Inclusion in Groups 3 and 4:Subjects must have previously received at least 1 dose of licensed monovalent meningococcal C conjugate (MenC) vaccine during infancy (i.e., before 12 months of age).

Exclusion Criteria:

  • Participation in the 4 weeks preceding the trial vaccination 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 (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • For Groups 1 and 2 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine)
  • For Groups 3 and 4 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent B meningococcal vaccine), except licensed monovalent meningococcal C conjugate (MenC) vaccination received during infancy
  • 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 (specifically, but not limited to, 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
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
  • Personal history of Guillain-Barré Syndrome
  • Verbal report of thrombocytopenia, as reported by the parent/legally acceptable representative contraindicating intramuscular vaccination in the Investigator's opinion
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
  • Chronic illness 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 ≥ 38.0°C). 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 a 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): NCT02955797


Locations
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Finland
Investigational Site 309
Espoo, Finland, 02230
Investigational Site 301
Helsinki, Finland, 00100
Investigational Site 306
Helsinki, Finland, 00930
Investigational Site 302
Järvenpää, Finland, 04400
Investigational Site 304
Kokkola, Finland, 67100
Investigational Site 307
Oulu, Finland, 90220
Investigational Site 303
Pori, Finland, 28100
Investigational Site 305
Seinäjoki, Finland, 60100
Investigational Site 308
Tampere, Finland, 33100
Investigational Site 310
Turku, Finland, 20520
Germany
Investigator Site 412
Aschaffenburg, Germany, 63739
Investigator Site 401
Bramsche, Germany, 49565
Investigator Site 407
Bretten, Germany, 75015
Investigator Site 411
Bönnigheim, Germany, 74357
Investigator Site 413
Datteln, Germany, 45711
Investigator Site 404
Erfurt, Germany, 99086
Investigator Site 409
Goch, Germany, 47574
Investigator Site 415
Hamburg, Germany
Investigator Site 402
Mönchengladbach, Germany, 41236
Investigator Site 408
Mönchengladbach, Germany, 41236
Investigator Site 406
Schönau, Germany, 83471
Investigator Site 403
Tauberbischofsheim, Germany, 97941
Hungary
Investigational Site 102
Budapest, Hungary, H 1042
Investigational Site 101
Budapest, Hungary, H 1188
Investigational Site 104
Győr, Hungary, H 9024
Investigational Site 105
Miskolc, Hungary, H 3527
Investigational Site 103
Szeged, Hungary, H 6723
Investigational Site 106
Székesfehérvár, Hungary, H 8000
Spain
Investigator Site 203
Barcelona, Spain, 08950
Investigator Site 204
Galicia, Spain, 15706
Investigator Site 205
Madrid, Spain, 28007
Investigator Site 202
Madrid, Spain, 28046
Investigator Site 201
Sevilla, Spain, 41014
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur SA

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02955797     History of Changes
Other Study ID Numbers: MET51
U1111-1161-2935 ( Other Identifier: WHO )
2016-000749-30 ( EudraCT Number )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Meningitis
MenACYW conjugate vaccine
Nimenrix®
Menjugate®
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs