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

Meningococcal Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601731
• Other study ID #: V59P5E1
• Secondary ID: 2007-004978-16
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2008
• Last updated: October 14, 2014
• Start date: February 2008
• Est. completion date: September 2010

Study information

• Verified date: October 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Months to 63 Months

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• MenACWY-CRM197
Blood test, 40-months and 60-months children
• Blood test
Blood test, 40-months and 60-months children

Locations

Country	Name	City	State
Canada	Clinical Trials Research Center	Halifax
Canada	Vaccine Evaluation Center	Vancouver
United Kingdom	Oxford Vaccine Group	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Vaccines	Novartis

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With hSBA =1:8	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.	At 40 and 60 months of age	No
Secondary	Percentage of Subjects With hSBA =1:4	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.	At 40 and 60 months of age	No
Secondary	GMTs in Subjects Within Each Site and in Age-Matched Control Subjects	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.	At 40 and 60 months of age	No