Skip to main content
OpenTrials
Completed

NCT Number: NCT00474487

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Meningococcal ACWY Polysaccharide Vaccine

Biological

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

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.

Meningococcal ACWY conjugate vaccine

Biological

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

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.

Primary outcomes

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

    Time frame: Days 1 to 7

    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.

Secondary outcomes

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

    Time frame: 1 month postvaccination

    Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years).

    Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

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

    Time frame: 1 month postvaccination

    Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years).

    Seroresponse: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

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

    Time frame: 1 month postvaccination

    Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.

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

    Time frame: 1 month postvaccination

    Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age.

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

    Time frame: Days 1 to 7

    Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).

  6. Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years

    Time frame: Days 1 to 7

    Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase 3, Multi-center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
May 17, 2007
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.