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

NCT01274897 | Completed Phase 3 Results

• 1 other identifier: V59_39
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  day 29

Secondary Outcomes (3)

• Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y 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.

  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

Study Arms (2)

MenACWY-CRM

EXPERIMENTAL

Subjects received one dose of MenACWY-CRM conjugate vaccine.

Biological: Novartis MenACWY-CRM

Placebo

PLACEBO COMPARATOR

Subjects received the saline placebo.

Biological: Saline Placebo

Interventions

Novartis MenACWY-CRM BIOLOGICAL

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

MenACWY-CRM

Saline Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 11 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals eligible for enrollment in this study were those:
• who were 11-55 years of age inclusive and who, after the nature of the study had been explained:
• had given written assent and/or for whom the parent/legal representative had provided written informed consent (11-19 years of age).
• had provided written informed consent (20-55 years of age).
• 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).
• who were in good health as determined by
• medical history
• physical assessment
• clinical judgment of the investigator
• who had negative urine pregnancy test for women of childbearing age.

You may not qualify if:

• Individuals not eligible to be enrolled in the study were those:
• who were unwilling or unable to give written informed assent or consent to participate in the study.
• who were perceived to be unreliable or unavailable for the duration of the study period.
• who were planning to leave the area of the study site before the end of the study period.
• who had a previous or suspected disease caused by N. meningitidis.
• who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.
• who had previously been immunized with a meningococcal vaccine.
• 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.
• 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)
• 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.
• 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).
• who had epilepsy or any progressive neurological disease.
• who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components, including latex allergies.
• who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
• 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)

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (8)

Department of Pediatrics, Kosin University Gospel Hospital

Busan, South Korea

Location

Department of Pediatrics, Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Deaprtment of Pediatrics, Inha University Hospital

Incheon, South Korea

Location

Division of Infectious Diseases, Inha University Hospital

Incheon, South Korea

Location

Pediatrics and Adolescent medicine, Myongji Hospital Kwandong University

Kyunggi, South Korea

Location

Department of Pediatrics, Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Division of Infection Diseases, Seoul National University Hospital

Seoul, South Korea

Location

Division of Infectious Diseases, Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal; Meningitis

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2011
• First Posted: January 12, 2011
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 16, 2012
• Results First Posted: October 16, 2012

Record last verified: 2012-09

Locations

KR (8)