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

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

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Disease; Meningococcal Meningitis
• Intervention / Treatment: Biological: Novartis MenACWY-CRM; Biological: Saline Placebo

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Department of Pediatrics, Kosin University Gospel Hospital
  • Gyeonggi-do, Korea, Republic of
    • Department of Pediatrics, Seoul National University Bundang Hospital
  • Incheon, Korea, Republic of
    • Deaprtment of Pediatrics, Inha University Hospital
  • Incheon, Korea, Republic of
    • Division of Infectious Diseases, Inha University Hospital
  • Kyunggi, Korea, Republic of
    • Pediatrics and Adolescent medicine, Myongji Hospital Kwandong University
  • Seoul, Korea, Republic of
    • Department of Pediatrics, Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Division of Infection Diseases, Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Division of Infectious Diseases, Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.	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: for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.	day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.	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).	day 1 and day 29
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.	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).	day 1 and day 29
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination		during 7 days of vaccination

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 9, 2011
• First Submitted That Met QC Criteria: January 11, 2011
• First Posted (Estimate): January 12, 2011

Study Record Updates

• Last Update Posted (Estimate): October 16, 2012
• Last Update Submitted That Met QC Criteria: September 17, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Adolescents; Adults; Meningitis; Persistence; Conjugate Vaccine; Meningococcal; ACWY-CRM
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Meningococcal Infections; Gastrointestinal Agents; Cathartics; Lactitol
• Other Study ID Numbers: V59_39