Clinical trial NCT01274897: A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea
Official title: A Phase 3, Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 11 to 55 Years of Age in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Meningococcal Meningitis
Keywords: Meningococcal
ACWY-CRM
Conjugate Vaccine
Meningitis
Adolescents
Persistence
Adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-12
Enrollment: 450
Sex: ALL
Minimum age (years): 11
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
timeFrame: day 29
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
timeFrame: day 1 and day 29
measure: Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
timeFrame: day 1 and day 29
measure: Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination
timeFrame: during 7 days of vaccination
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of Pediatrics, Kosin University Gospel Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Department of Pediatrics, Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Deaprtment of Pediatrics, Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Division of Infectious Diseases, Inha University Hospital
city: Kyunggi
country: Korea, Republic of
facility: Pediatrics and Adolescent medicine, Myongji Hospital Kwandong University
city: Seoul
country: Korea, Republic of
facility: Department of Pediatrics, Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Division of Infection Diseases, Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Division of Infectious Diseases, Korea University Guro Hospital
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References: