Safety and Immune Response Study of an Investigational Pn... | NCT00327522

Studies
Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

NCT00327522

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 13, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Prophylactic Pneumococcal Diseases

Interventions

pneumococcal vaccine

Countries

Belgium

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

Oct 2008

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

Jun 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 17, 2006

First Submission Date that Met QC Criteria

May 17, 2006

First Posted Date

May 18, 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

Oct 9, 2008

Last Update Posted Date

Oct 13, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

Detailed Description

The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
pneumococcal vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study;
Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy male or female between 18 and 40 years of age
23-valent pneumococcal polysaccharide vaccine naive adults.

Exclusion Criteria:

Previous vaccination against Streptococcus pneumoniae.
History of pneumonia within 3 years prior to the first vaccination
Any confirmed or suspected immunosuppressive or immunodeficient condition
All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
History of administration of an experimental/licensed vaccine containing similar adjuvants.
History of chronic alcohol consumption and/or drug abuse.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Ghent		9000	Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D022242	Pneumococcal Vaccines

Ancestor Terms

ID	Term
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products

Browse Leaves

Not provided

Browse Branches

Not provided