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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705379
Recruitment Status : Withdrawn
First Posted : October 12, 2012
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date October 9, 2012
First Posted Date October 12, 2012
Last Update Posted Date December 1, 2016
Study Start Date March 2013
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 9, 2012)
  • All adverse events [ Time Frame: Day 29 ]
  • All serious adverse events [ Time Frame: Day 29 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01705379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy male and female subjects 2 years of age and older
Condition Meningococcal Disease
Intervention Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Immunization
Study Groups/Cohorts MenACWY-CRM
2 years of age and older
Intervention: Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 30, 2016)
0
Original Estimated Enrollment
 (submitted: October 9, 2012)
3000
Estimated Study Completion Date April 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01705379
Other Study ID Numbers V59_45OB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor Novartis Vaccines
Collaborators Not Provided
Investigators Not Provided
PRS Account Novartis
Verification Date November 2016