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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01274897
First received: January 9, 2011
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Meningococcal Disease
Meningococcal Meningitis
Biological: Novartis MenACWY-CRM
Biological: Saline Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. [ Time Frame: day 29 ] [ Designated as safety issue: No ]

    Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination).

    Seroresponse is defined as:

    1. for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.
    2. for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.


Secondary Outcome Measures:
  • Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. [ Time Frame: day 1 and day 29 ] [ Designated as safety issue: No ]
    Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).

  • Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. [ Time Frame: day 1 and day 29 ] [ Designated as safety issue: No ]
    Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination).

  • Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination [ Time Frame: during 7 days of vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 450
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACWY-CRM
Subjects received one dose of MenACWY-CRM conjugate vaccine.
Biological: Novartis MenACWY-CRM
All subjects had blood drawn at Day 1 and Day 29.
Placebo Comparator: Placebo
Subjects received the saline placebo.
Biological: Saline Placebo
All subjects had blood drawn at Day 1 and Day 29.

  Eligibility

Ages Eligible for Study:   11 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01274897

Locations
Korea, Republic of
Department of Pediatrics, Kosin University Gospel Hospital
Busan, Korea, Republic of
Department of Pediatrics, Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of
Division of Infectious Diseases, Inha University Hospital
Incheon, Korea, Republic of
Deaprtment of Pediatrics, Inha University Hospital
Incheon, Korea, Republic of
Pediatrics and Adolescent medicine, Myongji Hospital Kwandong University
Kyunggi, Korea, Republic of
Division of Infection Diseases, Seoul National University Hospital
Seoul, Korea, Republic of
Division of Infectious Diseases, Korea University Guro Hospital
Seoul, Korea, Republic of
Department of Pediatrics, Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01274897     History of Changes
Other Study ID Numbers: V59_39
Study First Received: January 9, 2011
Results First Received: March 13, 2012
Last Updated: September 17, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Novartis:
Meningococcal
ACWY-CRM
Conjugate Vaccine
Meningitis
Adolescents
Persistence
Adults

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Lactitol
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014