You are here

Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Herson, Queensland, 4006 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-25 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Completed study 6108A1-500.

2. Hemoglobin level ≥12.0 and ≤16.5 g/dL for female subjects and ≥13.0 and ≤18.5 g/dL for
male subjects.

3. Body weight ≥45 and ≤120 kg.

4. Systolic blood pressure >90 and

5. Diastolic blood pressure >60 and

6. Able to be contacted by telephone.

7. For all female subjects: have a negative urine pregnancy test unless the subject is
surgically sterile.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Bleeding diathesis or condition associated with prolonged bleeding time.

2. Prior antibiotic use (within 14 days).

3. Any clinically significant chronic disease that, in the investigator's judgment may be
worsened by blood draw.

NCT00500032
Pfizer
Completed
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Healthy Volunteers
NCT03184168
Males
18+
Years
Madison, Wisconsin
Healthy Adult Subjects, Healthy Elderly Subjects
NCT02691702
All Genders
18+
Years
Multiple Sites
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers
Blood Collection for Use in Serological Assay Development From Healthy Adult Volunteers Who Completed Study 6108A1-500
Subjects who have completed study 6108A1-500, in which our experimental meningoccal B vaccine or placebo was administered, will be approached for inclusion into this study which is purely for blood draw. The sera will be used for assay development.

The purpose of this protocol is to analyze the collection of blood volumes (approximately 200 to 470 mL per bleed) from volunteer donors who previously completed study 6108A1-500. As such, the inclusion and exclusion criteria are consistent with the Australian Red Cross guidelines for blood donation.

The 6108A1-500 study is an ongoing, double-blind, ascending-dose, randomized, placebo-controlled trial to assess the safety and tolerability of ascending doses of rLP2086 with aluminum phosphate (AlPO4) adjuvant, in healthy adults aged 18 to 25 years. Upon completion of participation in the 6108A1-500 study, subjects will be approached to participate in this blood sampling study. The sites participating in this blood sampling study are the same sites participating in the 6108A1-500 study.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Healthy
Procedure: blood draw
Blood draw from subjects previously vaccinated in 6108A1-500 trial
Experimental: Arm 1
Active Comparator for all subjects enrolled in 6108A1-500
Intervention: Procedure: blood draw
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
August 2008
August 2008   (Final data collection date for primary outcome measure)

Main Inclusion Criteria:

  1. Completed study 6108A1-500.
  2. Hemoglobin level ?12.0 and ?16.5 g/dL for female subjects and ?13.0 and ?18.5 g/dL for male subjects.
  3. Body weight ?45 and ?120 kg.
  4. Systolic blood pressure >90 and <180 mm Hg.
  5. Diastolic blood pressure >60 and <100 mm Hg.
  6. Able to be contacted by telephone.
  7. For all female subjects: have a negative urine pregnancy test unless the subject is surgically sterile.

Main Exclusion Criteria:

  1. Bleeding diathesis or condition associated with prolonged bleeding time.
  2. Prior antibiotic use (within 14 days).
  3. Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.
Sexes Eligible for Study: All
18 Years to 25 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00500032
6108A1-1000
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now