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

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

MenACWY-CRM197

Blood test

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Prevention of Meningococcal disease

Eligibility Criteria

40 Months - 63 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinical Trials Research Center
Vaccine Evaluation Center
Oxford Vaccine Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjuvanted MenACWY vaccine group

Non-adjuvanted MenACWY vaccine group

Arm Description

Blood test

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00601731

First Posted

January 15, 2008

Last Updated

October 14, 2014

Sponsor

Novartis Vaccines

Collaborators

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00601731

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

Collaborators

Novartis

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningococcal Disease

Keywords

Prevention of Meningococcal disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

382 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adjuvanted MenACWY vaccine group

Arm Type

Experimental

Arm Description

Blood test

Arm Title

Non-adjuvanted MenACWY vaccine group

Arm Type

Active Comparator

Arm Description

Blood test

Intervention Type

Biological

Intervention Name(s)

MenACWY-CRM197

Intervention Description

Blood test, 40-months and 60-months children

Intervention Type

Biological

Intervention Name(s)

Blood test

Intervention Description

Blood test, 40-months and 60-months children

Primary Outcome Measure Information:

Title

Percentage of Subjects With hSBA ≥1:8

Description

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.

Time Frame

At 40 and 60 months of age

Secondary Outcome Measure Information:

Title

Percentage of Subjects With hSBA ≥1:4

Description

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.

Time Frame

At 40 and 60 months of age

Title

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

Description

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.

Time Frame

At 40 and 60 months of age

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Months

Maximum Age & Unit of Time

63 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines

Organizational Affiliation

Novartis Vaccines

Official's Role

Study Chair

Facility Information:

Facility Name

Clinical Trials Research Center

City

Halifax

Country

Canada

Facility Name

Vaccine Evaluation Center

City

Vancouver

Country

Canada

Facility Name

Oxford Vaccine Group

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

22394992

Citation

Khatami A, Snape MD, Davis E, Layton H, John T, Yu LM, Dull PM, Gill CJ, Odrjlin T, Dobson S, Halperin SA, Langley JM, McNeil SA, Pollard AJ. Persistence of the immune response at 5 years of age following infant immunisation with investigational quadrivalent MenACWY conjugate vaccine formulations. Vaccine. 2012 Apr 16;30(18):2831-8. doi: 10.1016/j.vaccine.2012.02.046. Epub 2012 Mar 3.

Results Reference

derived

Meningococcal Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial