We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01766206
Recruitment Status : Recruiting
First Posted : January 11, 2013
Last Update Posted : January 22, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Meningococcal Disease Biological: Novartis Meningococcal ACWY Conjugate Vaccine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3960 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 1, 2013
Estimated Primary Completion Date : February 15, 2018
Estimated Study Completion Date : February 15, 2018


Arms and Interventions

Arm Intervention/treatment
Experimental: MenACWY-CRM
2 months to 55 years of age
Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Immunization


Outcome Measures

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

  2. All unsolicited AEs reported [ Time Frame: Day 1 to Day 7 postvaccination ]
  3. Medically attended AEs and Serious AEs (SAEs) reported [ Time Frame: Day 1 to Day 29 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Months to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766206


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

  Show 56 Study Locations
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 ( Other Identifier: Novartis )
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: January 22, 2018
Last Verified: January 2018

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

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