A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea

NCT ID: NCT01274897

Last Updated: 2012-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-03-31

Brief Summary

This study is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.

Conditions

Meningococcal Disease; Meningococcal Meningitis

Keywords

Meningococcal; ACWY-CRM; Conjugate Vaccine; Meningitis; Adolescents; Persistence; Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

MenACWY-CRM

Subjects received one dose of MenACWY-CRM conjugate vaccine.

Group Type: EXPERIMENTAL

Novartis MenACWY-CRM

Intervention Type: BIOLOGICAL

All subjects had blood drawn at Day 1 and Day 29.

Placebo

Subjects received the saline placebo.

Group Type: PLACEBO_COMPARATOR

Saline Placebo

Intervention Type: BIOLOGICAL

All subjects had blood drawn at Day 1 and Day 29.

Interventions

Novartis MenACWY-CRM

All subjects had blood drawn at Day 1 and Day 29.

Intervention Type: BIOLOGICAL

Saline Placebo

All subjects had blood drawn at Day 1 and Day 29.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Individuals eligible for enrollment in this study were those:

1. who were 11-55 years of age inclusive and who, after the nature of the study had been explained:

1. had given written assent and/or for whom the parent/legal representative had provided written informed consent (11-19 years of age).

2. had provided written informed consent (20-55 years of age).

2. who the investigator believed that they or their parents/legal representatives would comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).

3. who were in good health as determined by

1. medical history

2. physical assessment

3. clinical judgment of the investigator

4. who had negative urine pregnancy test for women of childbearing age.

Exclusion Criteria

Individuals not eligible to be enrolled in the study were those:

1. who were unwilling or unable to give written informed assent or consent to participate in the study.

2. who were perceived to be unreliable or unavailable for the duration of the study period.

3. who were planning to leave the area of the study site before the end of the study period.

4. who had a previous or suspected disease caused by N. meningitidis.

5. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.

6. who had previously been immunized with a meningococcal vaccine.

7. who had received any investigational or non-registered product (drug or vaccine)within 28 days prior to enrollment or who expected to receive an investigational drug or vaccine prior to the completion of the study.

8. who had received any licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 30 days from the study vaccines. (Exception: Influenza vaccine was administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)

9. who had experienced within the 7 days prior to enrollment significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ≥38°C) within 3 days prior to enrollment.

10. who had 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).

11. who had epilepsy or any progressive neurological disease.

12. who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components, including latex allergies.

13. who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

1. received immunosuppressive therapy within 28 days prior to enrollment(any systemic corticosteroid administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 28 days prior to enrollment, or cancer chemotherapy)

2. received immunostimulants

3. received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study

14. who were known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

15. who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines and Diagnostics

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Department of Pediatrics, Kosin University Gospel Hospital

Busan, , South Korea

Department of Pediatrics, Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Deaprtment of Pediatrics, Inha University Hospital

Incheon, , South Korea

Division of Infectious Diseases, Inha University Hospital

Incheon, , South Korea

Pediatrics and Adolescent medicine, Myongji Hospital Kwandong University

Kyunggi, , South Korea

Department of Pediatrics, Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Division of Infection Diseases, Seoul National University Hospital

Seoul, , South Korea

Division of Infectious Diseases, Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

V59_39

Identifier Type: -

Identifier Source: org_study_id