Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT00518492 |
Date of registration:
|
16/08/2007 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
|
Scientific title:
|
Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500 |
Date of first enrolment:
|
August 2007 |
Target sample size:
|
73 |
Recruitment status: |
Completed |
URL:
|
http://clinicaltrials.gov/show/NCT00518492 |
Study type:
|
Interventional |
Study design:
|
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
|
Phase:
|
Phase 1
|
|
Countries of recruitment
|
Australia
| | | | | | | |
Contacts
|
Name:
|
Medical Monitor |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Wyeth is now a wholly owned subsidiary of Pfizer |
|
Name:
|
Trial Manager |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
For Australia: medinfo@wyeth.com |
| |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Completed study 6108A1-500 (three doses administered and visit 9 completed).
Exclusion Criteria:
- Bleeding diathesis or condition associated with prolonged bleeding time.
- Any clinically significant chronic disease that, in the investigators judgment may be
worsened by blood draw.
Age minimum:
18 Years
Age maximum:
25 Years
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Healthy
|
Intervention(s)
|
Procedure: Blood Sampling
|
Primary Outcome(s)
|
Immunogenicity at 6 and 12 months post 6108A1-500 study.
[Time Frame: 6 and 12 months]
|
Secondary ID(s)
|
6108A1-1002
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|