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

Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274897
• Other study ID #: V59_39
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2011
• Last updated: September 17, 2012
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: September 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Disease
• Meningococcal Infections
• Meningococcal Meningitis

Intervention

Biological:
• Novartis MenACWY-CRM
All subjects had blood drawn at Day 1 and Day 29.
• Saline Placebo
All subjects had blood drawn at Day 1 and Day 29.

Locations

Country	Name	City	State
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	Deaprtment of Pediatrics, Inha University Hospital	Incheon
Korea, Republic of	Division of Infectious Diseases, Inha University Hospital	Incheon
Korea, Republic of	Pediatrics and Adolescent medicine, Myongji Hospital Kwandong University	Kyunggi
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	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination		during 7 days of vaccination	Yes