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

• ClinicalTrials.gov Identifier: NCT01705379
• Recruitment Status: Withdrawn
• First Posted: October 12, 2012
• Last Update Posted: December 1, 2016
• Sponsor: Novartis Vaccines
• Information provided by (Responsible Party): Novartis ( Novartis Vaccines )

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.

Condition or disease	Intervention/treatment
Meningococcal Disease	Biological: Novartis Meningococcal ACWY Conjugate Vaccine

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• 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 Start Date: March 2013
• Estimated Primary Completion Date: April 2016
• Estimated Study Completion Date: April 2016

Groups and Cohorts

Group/Cohort	Intervention/treatment
MenACWY-CRM; 2 years of age and older	Biological: Novartis Meningococcal ACWY Conjugate Vaccine; Immunization

Outcome Measures

Primary Outcome Measures :

1. All adverse events [ Time Frame: Day 29 ]
2. All serious adverse events [ Time Frame: Day 29 ]

Eligibility Criteria

• Ages Eligible for Study: 2 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female subjects 2 years of age and older

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT01705379 History of Changes
• Other Study ID Numbers: V59_45OB
• First Posted: October 12, 2012
• Last Update Posted: December 1, 2016
• Last Verified: November 2016

Keywords provided by Novartis ( Novartis Vaccines ):

Neisseria meningitidis, conjugate vaccine, phase IV clinical trial

Additional relevant MeSH terms:

Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Lactitol; Vaccines; Immunologic Factors; Physiological Effects of Drugs; Cathartics; Gastrointestinal Agents