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Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years

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ClinicalTrials.gov Identifier: NCT03077438
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The aim of this trial is to evaluate the immunogenicity and describe the safety of MenACYW conjugate vaccine compared to MENVEO® in healthy children 2 to 9 years of age in the United States.

Primary objective:

- To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years.

Secondary objectives:

  • To compare the hSBA antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age
  • To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.
  • To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.

Observational objective:

- To describe the safety profile of MenACYW conjugate vaccine and that of the licensed MENVEO®.


Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Meningitis Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Phase 3

Detailed Description:

Healthy participants will be enrolled, randomized, and will receive a single dose of either MenACYW conjugate vaccine or MENVEO®.

All participants will be assessed for immunogenicity at baseline (pre-vaccination) and at Visit 2 (post-vaccination). Safety information will be collected post each vaccination and throughout the entire study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 999 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 Administered in Healthy Children 2 to 9 Years of Age
Actual Study Start Date : February 24, 2017
Actual Primary Completion Date : October 10, 2017
Actual Study Completion Date : October 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

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

Active Comparator: MENVEO®
Participants randomized to receive MENVEO®
Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
0.5 mL, Intramuscular
Other Name: MENVEO®




Primary Outcome Measures :
  1. Antibody titers against meningococcal serogroups A, C, Y, and W at baseline and post-vaccination with either a single dose of MenACYW conjugate vaccine or MENVEO® [ Time Frame: Day 30 post vaccination ]
    Meningococcal serogroups A, C, Y, and W antibodies will be measured by serum bactericidal assays using human complement (hSBA)


Secondary Outcome Measures :
  1. Geometric mean titers of antibodies against meningococcal serogroups A, C, Y, and W before and after vaccination with MenACYW conjugate vaccine or MENVEO® [ Time Frame: Day 30 post vaccination ]
    Meningococcal serogroups A, C, Y, and W antibodies will be measured by serum bactericidal assays using human complement (hSBA)

  2. Number of participants with seroresponse against meningococcal serogroups A, C, Y, and W after vaccination with MenACYW conjugate vaccine or MENVEO® [ Time Frame: Day 30 post vaccination ]
    Meningococcal serogroups A, C, Y, and W antibodies will be measured by serum bactericidal assays using human complement (hSBA)

  3. Number of participants reporting solicited reactions, unsolicited adverse events, serious adverse events, and adverse events of special interest following vaccination with MenACYW conjugate vaccine or MENVEO® [ Time Frame: Day 180 post vaccination ]
    Solicited injection site reactions and systemic reactions (Day 0 to Day 7 post each vaccination); unsolicited adverse events, including serious adverse events and adverse events of special interest will be collected throughout the study



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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 2 to 9 years on the day of inclusion
  • Assent form has been signed and dated by the participant (as required by local regulations) and informed consent form (ICF) has been signed and dated by parent(s) or guardian
  • Participant and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

  • Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche
  • 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 the study investigational vaccines. This exception includes monovalent, multivalent, live, and attenuated influenza vaccines
  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, W; or meningococcal B serogroup containing vaccine)
  • 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 (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling 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
  • Verbal report of thrombocytopenia, contraindicating intramuscular vaccination by the Investigator's judgment
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
  • Personal history of Guillain-Barré syndrome
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
  • 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's judgment) on the day of vaccination or febrile illness (temperature ≥100.4°F). A prospective participant 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): NCT03077438


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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Officer, MD Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03077438     History of Changes
Other Study ID Numbers: MET35
U1111 1161 2625 ( Other Identifier: WHO )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Meningitis
MenACYW conjugate vaccine
MENVEO®
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