Persistence of Antibody Response to N. Meningitidis Group... | NCT00316654

Studies
Persistence of Antibody Response to N. Meningitidis Group C in Children

NCT00316654

Sponsor

Novartis Vaccines

Status

Completed

Last Update Posted

Jul 25, 2017Actual

Enrollment

489Actual

Phase

Phase 4

Conditions

Prevention of Meningococcal Infection

Interventions

Meningococcal C conjugate vaccine

Countries

Poland
Spain

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

ID	Type	Description	Link
2004-001522-24	EudraCT Number

Official Title

A Phase IV,Multi-Center,Open-Label,Unrandomized Study to Evaluate the Persistence of Antibody Response to N.Meningitidis Group C,Before & After 2 Doses of the Conjugate Pneumococcal Vaccine,in Children Seven Months & Older Who Previously Received Immunization With Chiron Meningococcal C Conjugate Vaccine & a Hexavalent Infant Vaccine According to the Applicable Infant Immunization Schedule

Status Module

Record Verification Date

Jul 2017

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

Feb 2005

Primary Completion Date

Oct 2005Actual

Completion Date

Oct 2005Actual

First Submitted Date

Apr 19, 2006

First Submission Date that Met QC Criteria

Apr 19, 2006

First Posted Date

Apr 21, 2006Estimated

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

Jul 21, 2017

Last Update Posted Date

Jul 25, 2017Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

489Actual

Name	Type	Description	Arm Group Labels	Other Names
Meningococcal C conjugate vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immunogenicity: serum antibody responses, as measured by bactericidal activity,using hBCA

Secondary Outcomes

Measure	Description	Time Frame
Evaluate and compare persistence of antibody response to N. meningitidis serogroup C as measured by serum bactericidal activity
safety and tolerability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy children

Exclusion Criteria:

previous ascertained or suspected disease caused by N. meningitidis
previous significant acute or chronic infections
any other serious disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Vaccines Drug Information Services	Novartis Vaccines & Diagnostics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Olsztyn, Lubartów, Kielce, Kraków, Bydgoszcz			Poland

Intervention Browse Module

MeSH Terms

ID	Term
C410218	serogroup C meningococcal conjugate vaccine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided