Understanding Immunity Persistence After Adolescent MenC... | NCT01459432

Studies
Understanding Immunity Persistence After Adolescent MenC Vaccination

NCT01459432

Sponsor

University of Oxford

Status

Completed

Last Update Posted

Nov 9, 2015Estimated

Enrollment

134Actual

Phase

Not provided

Conditions

Antibody Persistance After Booster Dose of Men C Vaccine

Interventions

Venepuncture and blood sample collection.

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Apr 2012Actual

Completion Date

Not provided

First Submitted Date

Oct 21, 2011

First Submission Date that Met QC Criteria

Oct 24, 2011

First Posted Date

Oct 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2015

Last Update Posted Date

Nov 9, 2015Estimated

Description Module

Brief Summary

The main purpose of this study is to evaluate the duration of immunity after a booster dose of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does seroprotection persist beyond teenage years and into the early twenties? This is the age group which is most likely to carry the organism and to transmit it to other members of the population. If a booster dose of MenC vaccine given to adolescents does produce protective levels of antibody which persist into early adulthood, this would strengthen the case for such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a resurgence of the disease in the future.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Follow-on blood sample from previous study			Other: Venepuncture and blood sample collection.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Venepuncture and blood sample collection.	Other	Venepuncture and blood sample collection.	Follow-on blood sample from previous study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of participants with rSBA titre ≥1:8 (correlate of protection).		4 months

Secondary Outcomes

Measure	Description	Time Frame
Geometric mean titre (GMT) rSBA.		4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants who completed clinical study M14P2E1
Participant who are willing to participate and who would be expected to comply with the requirements of the protocol
Participants who have given informed consent for participation in the study

Exclusion Criteria:

History of invasive meningococcal C disease (or any case of invasive meningococcal disease where the serotype was unknown)
Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection
Severe blood clotting disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

23 Years

Standard Ages

Adult

Study Population

Young adults, approximately 20 - 23 years old.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oxford Vaccine Group		Oxford		OX3 8NQ	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23853000	Derived	de Whalley PC, Snape MD, Plested E, Thompson B, Nuthall E, Omar O, Borrow R, Pollard AJ. Long-term seroprotection after an adolescent booster meningococcal serogroup C vaccination. Arch Dis Child. 2013 Sep;98(9):686-91. doi: 10.1136/archdischild-2013-303893. Epub 2013 Jul 13.

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis