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Completed

NCT Number: NCT01018732

A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWY

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

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Key information

Conditions

Meningococcal Disease 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 Meningococcal Meningitis Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

16 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rochester, Minnesota, United States

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About this study

Persistence of antibody response at 5 years after one dose of MenACWY or Menomune

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination.
  • Female subjects were to be negative for pregnancy

Exclusion criteria

  • History of meningococcal disease
  • Receipt of any meningococcal vaccine outside of parent study (V59P6)
  • Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy
  • receipt of any vaccine 14 days prior to the study, or expected through the duration of the study
  • any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study

Treatment and study plan

Novartis Meningococcal (MenACWY-CRM) vaccine

Biological

All subjects will have blood draws at Day 1, Day 8, and Day 29.

Primary outcomes

  1. Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination

    Time frame: Day 1 (5 years after primary vaccination)

    Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

  2. Geometric Mean Titer After Booster Vaccination

    Time frame: Day 8, Day 29 (5 years after primary vaccination)

    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

Secondary outcomes

  1. Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination

    Time frame: Day 1 (5 years after primary vaccination )

    Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

  2. Geometric Mean Titer at 5 Years After Primary Vaccination

    Time frame: Day 1 (5 years after primary vaccination )

    Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y

  3. Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination

    Time frame: Day 7, Day 28 post booster (5 years after primary vaccination)

    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.

  4. Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination

    Time frame: Day 7, Day 28 post booster (5 years after primary vaccination)

    Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.

  5. Geometric Mean Ratio After Booster Vaccination

    Time frame: Day 8 and Day 29 (at 5 Years After Primary Vaccination)

    Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1

  6. Percentage of Subjects With hSBA Seroresponse After Booster Vaccination

    Time frame: Day 8, Day 29 (5 years after primary vaccination)

    For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.

  7. Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination

    Time frame: Up to Day 7

    Local and systemic reactions were solicited to assess safety and tolerability of vaccination

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Collaborators

  • Novartis

Registry information

Official study title

A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents With Either MenACWY Conjugate Vaccine or Menomune®.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2009
Registry last updated
Jul 15, 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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