Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

NCT01410474 | Completed Phase 3 Results

• 1 other identifier: V59_49
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.

Conditions

Bacterial Meningitis

Keywords

Meningococcal; ACWY; bacterial meningitis; conjugate vaccine; healthy; children; adolescents; Taiwan

Outcome Measures

Primary Outcomes (1)

• Percentage of Overall 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 seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.

  Day 1 and Day 29

Secondary Outcomes (6)

• Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group

  Day 1 and Day 29

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

  Day 1 and 29

• Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination

  Day 1 and Day 29

• Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination

  Day 1 and 29

• Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years

  From day 1 through day 7 postvaccination

Study Arms (1)

2-18 years

EXPERIMENTAL

Biological: Meningococcal ACWY conjugate vaccine

Interventions

Meningococcal ACWY conjugate vaccine BIOLOGICAL

All subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29.

2-18 years

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy subjects from 2 up to and including 18 years of age
• Who are in good health as determined by : medical history, physical exam,clinical judgment of the investigator, who have a negative urine pregnancy test for female subjects ≥11 years of age

You may not qualify if:

• Individuals not eligible to be enrolled in the study were those:
• Who had a previous confirmed 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 enrolment.
• Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
• Who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the study vaccines.
• Who have experienced within the 7 days prior to enrolment significant acute infection or have experienced fever within 3 days prior to enrolment.
• Who have any serious acute, chronic or progressive who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
• Who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
• Who have a known or suspected impairment/alteration of immune function, either congenital or acquired
• Who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
• Who have Down's syndrome or other known cytogenic disorders.

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (3)

Mackay Memorial Hospital,

Taipei, Taiwan, 10002, China

Location

National Taiwan University Hospital

Taipei, Taiwan, 10002, China

Location

Far Eastern Memorial Hospital,

Taipei, Taiwan, 22060, China

Location

Related Publications (1)

• Huang LM, Chiu NC, Yeh SJ, Bhusal C, Arora AK. Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study. Vaccine. 2014 Sep 8;32(40):5177-84. doi: 10.1016/j.vaccine.2014.07.063. Epub 2014 Jul 27.

  PMID: 25075804 DERIVED

MeSH Terms

Conditions

Meningitis, Bacterial

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Results Point of Contact

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

RegistryContactVaccinesUS@novartis.com

Study Officials

• Li Min Huang, Dr.

  Dr. Li Min Huang, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Nan Chang Chiu, Dr.

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Shu Jen Yeh, Dr.

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 5, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 22, 2014
• Results First Posted: September 22, 2014

Record last verified: 2014-09

Locations

CN (3)