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Completed

NCT Number: NCT00601731

Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months

The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.

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Key information

Conditions

Meningococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

40 month–63 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Trials Research Center, Halifax, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
  • Control subjects: healthy 60 months old who had received a complete MenC immunization course

Exclusion criteria

  • Subjects with any serious, acute or chronic progressive disease

Treatment and study plan

MenACWY-CRM197

Biological

Blood test, 40-months and 60-months children

blood test

Biological

Blood test, 40-months and 60-months children

Primary outcomes

  1. Percentage of Subjects With hSBA ≥1:8

    Time frame: At 40 and 60 months of age

    Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.

Secondary outcomes

  1. Percentage of Subjects With hSBA ≥1:4

    Time frame: At 40 and 60 months of age

    Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.

  2. GMTs in Subjects Within Each Site and in Age-Matched Control Subjects

    Time frame: At 40 and 60 months of age

    The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Collaborators

  • Novartis

Registry information

Official study title

A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months Who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 28, 2008
Registry last updated
Oct 24, 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.

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