A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

NCT00474487 | Completed Phase 3 Results DMC

• 1 other identifier: V59P17
• Study Type: interventional
• Target: 2,831
• Locations: 2 countries
• Sites: 2

Brief Summary

This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.

Conditions

Meningococcal Meningitis; Meningococcal Infections

Keywords

Meningococcal; meningitis; vaccine; adolescents; adults

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years

  Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.

  Days 1 to 7

Secondary Outcomes (6)

• Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population

  1 month postvaccination

• Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population

  1 month postvaccination

• Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population

  1 month postvaccination

• Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population

  1 month postvaccination

• Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years

  Days 1 to 7

Study Arms (4)

Novartis MenACWY Vaccine (19 to 55 Years)

EXPERIMENTAL

Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years

Biological: MenACWY CRM (19 to 55 years)

Licensed polysaccharide vaccine

ACTIVE COMPARATOR

Licensed meningococcal ACWY polysaccharide vaccine

Biological: Meningococcal ACWY Polysaccharide Vaccine

Licensed Conjugate Vaccine

ACTIVE COMPARATOR

Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine

Biological: Meningococcal ACWY Conjugate Vaccine

Novartis MenACWY Vaccine (56 to 65 Years)

EXPERIMENTAL

Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years

Biological: Novartis MenACWY Vaccine (56 to 65 Years)

Interventions

Meningococcal ACWY Polysaccharide Vaccine BIOLOGICAL

One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.

Licensed polysaccharide vaccine

MenACWY CRM (19 to 55 years) BIOLOGICAL

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.

Novartis MenACWY Vaccine (19 to 55 Years)

Meningococcal ACWY Conjugate Vaccine BIOLOGICAL

One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.

Licensed Conjugate Vaccine

Novartis MenACWY Vaccine (56 to 65 Years) BIOLOGICAL

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.

Novartis MenACWY Vaccine (56 to 65 Years)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
• individuals who are available for all visits and telephone calls scheduled for the study;
• individuals who are in good health

You may not qualify if:

• individuals with a previous or suspected disease caused by N. meningitidis
• individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
• individuals with previous or suspected disease caused by N. meningitidis
• individuals with any serious acute, chronic or progressive disease
• individuals who are pregnant or breastfeeding

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (2)

Buenos Aires, Argentina

Buenos Aires, C1406DGI, Argentina

Location

Cali, Colombia; Bogota, Colombia

Cali; Bogota, Colombia

Location

Related Publications (1)

• Stamboulian D, Lopardo G, Lopez P, Cortes-Barbosa C, Valencia A, Bedell L, Karsten A, Dull PM. Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis. 2010 Oct;14(10):e868-75. doi: 10.1016/j.ijid.2010.03.017. Epub 2010 Jul 22.

  PMID: 20655261 RESULT

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningococcal Infections; Meningitis

Condition Hierarchy (Ancestors)

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

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: February 1, 2008
• Last Updated: April 21, 2014
• Results First Posted: August 4, 2010

Record last verified: 2014-04

Locations

AR (1); CO (1)