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

PHRR121218-000038

Protocol No. V59_45OB

Unspecified

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

A multicenter, single arm, postmarketing surveillance study. This study is a post-licensure 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 vaccination according to routine clinical practice and prescribing information.

Start Date Duration in Months Target Completion Date Actual Completion Date
2012-10-01 37 2015-11-01 0000-00-00

Terminated

Study terminated since local PMS not required anymore by FDA

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR
Institution Region
Novartis Healthcare Philippines, Inc. NCR
Name E-Mail Phone Number Postal Address
Leilani Sanchez, MD leilani_lee.sanchez@novartis.com +632 3687777 Novartis Healthcare Philippines, Inc. 5F Republic Glass Building, 196 Salcedo St. Legaspi
Name E-Mail Phone Number Postal Address
Leilani Sanchez, MD leilani_lee.sanchez@novartis.com +632 3687777 Novartis Healthcare Philippines, Inc. 5F Republic Glass Building, 196 Salcedo St. Legaspi
Name Expertise Affiliation
Anna Hassan, MD Pediatric Victor R. Potenciano Medical Center
Project Location Institutional Ethics Review Board
Victor R. Potenciano Medical Center VRP Medical Center Ethics Review Committee

Meningococcal Disease

-All adverse events [Time Frame: Day 29] [Designated as safety issue: Yes] -All serious adverse events [Time Frame: Day 29] [Designated as safety issue: Yes]

Unspecified

Terminated

  • Philippines

Clinical Trial

Unspecified

Unspecified

None

Inclusion criteria: Individuals eligible for enrolment in this study are those: 1. who are of any gender, from 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 menigococcal 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 sever malnutrition), who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. 9. who have history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components. 10. who are known to have 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.

Observational

Unspecified

Unspecified

Non-randomized

Not Applicable

Unspecified

Single Arm

A multicenter, single arm, postmarketing surveillance study. This study is a post-licensure 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 vaccination according to routine clinical practice and prescribing information.

Phase IV

3000

Unspecified

Study on-hold pending decision from FDA on termination of all PMS studies

01 Oct 2012

Utilization Utilization Info
No records found.

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