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

NCT00601731 | Completed Phase 2 Results

• 2 other identifiers: V59P5E12007-004978-16
• Study Type: interventional
• Target: 382
• Locations: 2 countries
• Sites: 3

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.

Conditions

Meningococcal Disease

Keywords

Prevention of Meningococcal disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Percentage of Subjects With hSBA ≥1:4

  At 40 and 60 months of age

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

  At 40 and 60 months of age

Study Arms (2)

Adjuvanted MenACWY vaccine group

EXPERIMENTAL

Blood test

Biological: MenACWY-CRM197

Non-adjuvanted MenACWY vaccine group

ACTIVE COMPARATOR

Blood test

Biological: Blood test

Interventions

MenACWY-CRM197 BIOLOGICAL

Blood test, 40-months and 60-months children

Adjuvanted MenACWY vaccine group

Blood test BIOLOGICAL

Blood test, 40-months and 60-months children

Non-adjuvanted MenACWY vaccine group

Eligibility Criteria

• Age: 40 Months - 63 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Subjects with any serious, acute or chronic progressive disease

Sponsors & Collaborators

• Novartis Vaccines: lead
• Novartis: collaborator

Study Sites (3)

Clinical Trials Research Center

Halifax, Canada

Location

Vaccine Evaluation Center

Vancouver, Canada

Location

Oxford Vaccine Group

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22394992 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 28, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 24, 2014
• Results First Posted: September 19, 2012

Record last verified: 2014-10

Locations

GB (1); CA (2)