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Completed

NCT Number: NCT00450437

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

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

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Key information

Conditions

Meningococcal Infections 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 Meningitis Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

11 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent

Exclusion criteria

  • Subjects with a previous or suspected disease caused by N. meningitidis
  • previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
  • previous or suspected disease caused by N. meningitidis
  • Any serious acute, chronic or progressive disease
  • Pregnant or breastfeeding

Treatment and study plan

MenACWY CRM

Biological

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.

Meningococcal ACWY conjugate vaccine

Biological

One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.

Primary outcomes

  1. Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

    Time frame: 28 days after vaccination

    The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)

  2. Percentage of Seroresponders, Ages 11 to 18 Years

    Time frame: 28 days after vaccination

    Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).

    Seroresponse to MenACWY: 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. Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years

    Time frame: 6 days after vaccination

    Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.

    Note: severe adverse events: unable to perform normal daily activity

  4. Percentage of Seroresponders, Ages 19 to 55 Years

    Time frame: 28 days after vaccination

    Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).

    Seroresponse to MenACWY: 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.

Secondary outcomes

  1. Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years

    Time frame: 28 days after vaccination

    The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).

    Seroresponse to MenACWY: 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, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years

    Time frame: 28 days after vaccination

    Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).

    Seroresponse to MenACWY: 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. Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years

    Time frame: 28 days after vaccination

    Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).

  4. Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years

    Time frame: Days 1 to 7

    Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase 3, Multi-center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Mar 22, 2007
Registry last updated
Jan 28, 2015

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.

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