Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 11 to 55 Years of Age in the Republic of South Korea
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Purpose
A multicenter, single arm, postmarketing 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 11 to 55 years of age, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
| Condition | Intervention |
|---|---|
|
Meningococcal Disease |
Biological: Novartis Meningococcal ACWY Conjugate Vaccine |
| Study Type: | Observational |
| 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 11 to 55 Years of Age in the Republic of South Korea. |
- Safety of a single dose of MenACWY-CRM vaccine in subjects from 11 to 55 years of age, as evaluated by local and systemic solicited Adverse Events [ Time Frame: Day 1 to Day 7 (postvaccination) ] [ Designated as safety issue: Yes ]Local reactions:Erythema, induration, pain. Systemic reactions:Chills, nausea, malaise, myalgia, arthralgia, headache,rash, fever.
- Safety of a single dose of MenACWY-CRM vaccine in subjects from 11 to 55 years of age, as evaluated by all Unsolicited Adverse Events [ Time Frame: Day 1 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 by Medically attended Adverse Events and Serious Adverse Events [ Time Frame: Day 1 to Day 29 (study termination) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 3300 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | February 2019 |
| Estimated Primary Completion Date: | November 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
MenACWY-CRM
11-55 years of age
|
Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Immunization
|
Eligibility| Ages Eligible for Study: | 11 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Healthy male and female subjects 11 to 55 years of age
Inclusion Criteria:
Individuals eligible for enrollment in this study are those:
- Male and female subjects from 11 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;
- To whom the nature of the study has been described and the subject or subject's parent/legal representative has provided written informed consent;
- Whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card);
- 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| Contact: Novartis Drug Information Services | +1 800 244 7668 |
| Korea, Republic of | |
| Konkuk University Hospital | Recruiting |
| Seoul, Korea, Republic of, 143-729 | |
| Study Chair: | Novartis Vaccines and Diagnostics | Novartis Vaccines |
More Information
Publications:
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT01766206 History of Changes |
| Other Study ID Numbers: | V59_62 |
| Study First Received: | January 8, 2013 |
| Last Updated: | March 21, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Novartis:
|
Neisseria meningitidis conjugate vaccine phase IV clinical trial |
Additional relevant MeSH terms:
|
Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Lactitol |
Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013