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Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older

Primary Purpose

Meningococcal Disease

Status
Withdrawn
Phase
Locations
Study Type
Observational
Intervention
Novartis Meningococcal ACWY Conjugate Vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Meningococcal Disease focused on measuring Neisseria meningitidis, conjugate vaccine, phase IV clinical trial

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Individuals eligible for enrolment in this study are those:

  1. who are of any gender, from the age of 2 and older, and to whom/whose parents or legally acceptable representatives the nature of the study has been described and the subject/subject's parent/legally acceptable representative has provided written informed consent.
  2. who the investigator believes that the subject and/or his or her parent/legal representative can and will comply with the requirements of the protocol.
  3. who are in good health as determined by clinical judgment of the investigator.

Exclusion Criteria:

Individuals not eligible to be enrolled in the study are those:

  1. who are unwilling or unable to give written informed consent or assent to participate in the study.
  2. who are perceived to be unreliable or unavailable for the duration of the study period.
  3. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
  4. who have received any investigational or non-registered product (drug or vaccine) within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
  5. who have received or who are planning to receive any vaccines (other than routine childhood vaccines) within 30 days before and after administration of study vaccine.

    (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)

  6. who have behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
  7. who are pregnant or breast feeding (female subjects of appropriate age) or who plan to become pregnant during the course of the study.
  8. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition), who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
  9. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
  10. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  11. who are included in study personnel or close family members of personnel conducting this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Arm Label

    MenACWY-CRM

    Arm Description

    2 years of age and older

    Outcomes

    Primary Outcome Measures

    All adverse events
    All serious adverse events

    Secondary Outcome Measures

    Full Information

    First Posted
    October 9, 2012
    Last Updated
    November 30, 2016
    Sponsor
    Novartis Vaccines
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01705379
    Brief Title
    Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older
    Official Title
    A Multicenter, Single Arm, Post Marketing Surveillance Study to Monitor the Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects 2 Years of Age and Older in the Philippines
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    April 2016 (Anticipated)
    Study Completion Date
    April 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Vaccines

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meningococcal Disease
    Keywords
    Neisseria meningitidis, conjugate vaccine, phase IV clinical trial

    7. Study Design

    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MenACWY-CRM
    Arm Description
    2 years of age and older
    Intervention Type
    Biological
    Intervention Name(s)
    Novartis Meningococcal ACWY Conjugate Vaccine
    Intervention Description
    Immunization
    Primary Outcome Measure Information:
    Title
    All adverse events
    Time Frame
    Day 29
    Title
    All serious adverse events
    Time Frame
    Day 29

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Individuals eligible for enrolment in this study are those: who are of any gender, from the age of 2 and older, and to whom/whose parents or legally acceptable representatives the nature of the study has been described and the subject/subject's parent/legally acceptable representative has provided written informed consent. who the investigator believes that the subject and/or his or her parent/legal representative can and will comply with the requirements of the protocol. who are in good health as determined by clinical judgment of the investigator. Exclusion Criteria: Individuals not eligible to be enrolled in the study are those: who are unwilling or unable to give written informed consent or assent to participate in the study. who are perceived to be unreliable or unavailable for the duration of the study period. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). who have received any investigational or non-registered product (drug or vaccine) within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study. who have received or who are planning to receive any vaccines (other than routine childhood vaccines) within 30 days before and after administration of study vaccine. (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination) who have behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. who are pregnant or breast feeding (female subjects of appropriate age) or who plan to become pregnant during the course of the study. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition), who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. who are included in study personnel or close family members of personnel conducting this study.
    Study Population Description
    Healthy male and female subjects 2 years of age and older
    Sampling Method
    Non-Probability Sample

    12. IPD Sharing Statement

    Learn more about this trial

    Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older

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