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Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01766206
First received: January 8, 2013
Last updated: July 22, 2016
Last verified: July 2016
  Purpose
A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.

Condition Intervention Phase
Meningococcal Disease
Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multicenter 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 From 2 Months to 55 Years of Age in the Republic of South Korea.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • local and systemic solicited Adverse Events (AEs) reported [ Time Frame: Day 1 (day of vaccination) to Day 7 postvaccination ] [ Designated as safety issue: Yes ]
    Safety of a single dose of MenACWY-CRM vaccine in subjects from 11 to 55 years of age, as evaluated

  • All unsolicited AEs reported [ Time Frame: Day 1 to Day 7 postvaccination ] [ Designated as safety issue: Yes ]
  • Medically attended AEs and Serious AEs (SAEs) reported [ Time Frame: Day 1 to Day 29 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3960
Study Start Date: March 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-CRM
2 months to 55 years of age
Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Immunization

  Eligibility

Ages Eligible for Study:   2 Months to 55 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Individuals eligible for enrolment in this study are those:

  1. male and female subjects from 2 months to 55 years of the age at the time of Visit 1 (including all 55 years old subjects, up to one day before their 56th year birthday), who are scheduled to receive vaccination with MenACWY-CRM conjugate vaccine, according to the local prescribing information and routine clinical practice;
  2. to whom the nature of the study has been described and the subject or subject's parent/legal representative has provided written informed consent;
  3. whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card);
  4. who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator.

Exclusion Criteria:

1. Contraindication, special warnings and/or precautions, as evaluated by the investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing information. In particular, should not be included in the study a subject who has ever had:

  • an allergic reaction to the active substances or any of the other ingredients of the study vaccine; an allergic reaction to diphtheria toxoid;
  • an illness with high fever; however, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination. Special care should be taken for subjects having haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766206

Contacts
Contact: US GSK Clinical trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Korea, Republic of
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 143-729
Contact: US GSK Clinical Trials    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01766206     History of Changes
Other Study ID Numbers: 205341  V59_62 
Study First Received: January 8, 2013
Last Updated: July 22, 2016
Health Authority: Korea: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Neisseria meningitidis
conjugate vaccine
phase IV clinical trial

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Lactitol
Immunologic Factors
Physiological Effects of Drugs
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 23, 2016