A Protocol to Collect Human Serum Samples From Healthy Adults for Use as Quality Controls Samples in GlaxoSmithKline (GSK) Biologicals' Assays
1 other identifier
interventional
359
1 country
1
Brief Summary
The purpose of this study is to collect serum samples for use as quality control samples in GSK assays. The serum samples need to include samples with low, medium and high antibody titers/concentrations, which cover the assay range.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2014
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2015
CompletedNovember 27, 2017
November 1, 2017
1.2 years
February 20, 2014
November 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
At Visit 2 (Day 0).
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
At 10 days post-vaccination.
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
At 30 days post-vaccination.
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
At 60 days post-vaccination.
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
At 120 days post-vaccination
Secondary Outcomes (1)
Occurrence of serious adverse events related to vaccination and to lack of vaccine efficacy throughout the study.
Throughout the study (Day 0 to Day 30 - Day 180).
Study Arms (9)
Mtdap1 Group
EXPERIMENTALSubjects will receive concomitant doses of Menveo and Boostrix.
Mtdap2 Group
EXPERIMENTALSubjects will receive concomitant doses of Menveo and Boostrix.
Mtdap3 Group
EXPERIMENTALSubjects will receive concomitant doses of Menveo and Boostrix.
Pneum1 Group
EXPERIMENTALSubjects will receive a dose of Pneumovax 23.
Pneum2 Group
EXPERIMENTALSubjects will receive a dose of Pneumovax 23.
Pneum 3 Group
EXPERIMENTALSubjects will receive a dose of Pneumovax 23.
Prev1 Group
EXPERIMENTALSubjects will receive a dose of Prevnar 13.
Prev2 Group
EXPERIMENTALSubjects will receive a dose of Prevnar 13.
Prev3 Group
EXPERIMENTALSubjects will receive a dose of Prevnar 13.
Interventions
One dose administered intramuscularly (IM) in the upper left deltoid of the arm.
One dose administered intramuscularly (IM) in the upper right deltoid of the arm.
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Eligibility Criteria
You may qualify if:
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female between, and including, 18 and 55 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study, with no medical conditions that in the opinion of the investigator prevents the subject from participating in the study.
- Subjects must weigh at least 110 pounds (50 kg).
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for at least 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception for the entire duration of the subject's participation in the trial.
You may not qualify if:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Subjects seropositive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV) or HIV.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. Inhaled and topical steroids are allowed.
- Administration of long-acting immune-modifying drugs at any time during the study period.
- Any antibiotic taken during the period from 14 days before the collection of plasma up to the day of collection of plasma.
- Any medication based on methyl phenidate HCL such as Metadate® or Concerta® or other CNS stimulants used to treat attention-deficit disorder or attention-deficit hyperactivity disorder taken during the period of 14 days before the collection of plasma up to the day of collection of plasma.
- Subjects who donated \>500 mLs of blood within 60 days prior to any plasma collection visits (plasmapheresis).
- Subjects who lost \>200 mL of red blood cells during a single apheresis procedure or lost red blood cells on more than one occasion during apheresis within the previous 60 days.
- Ongoing anemia as indicated by either (i) hemoglobin values, (ii) serum ferritin, or (iii) hematocrit values below the lower limit of the laboratory-specified reference range. If the laboratory results demonstrate an anemia, no further protocol procedures will be performed, and the subject will be referred for appropriate medical management. The subject may participate in this study following therapy and evidence that the anemia has been resolved.
- Bleeding disorder and/or a clinical laboratory platelet count value below the lower limit of the laboratory-specified reference range.
- Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and 30 days after the dose of vaccine, with the exception of licensed inactivated influenza vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Hypersensitivity to latex.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Sherbrooke, Quebec, J1H 2G2, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2014
First Posted
February 26, 2014
Study Start
April 1, 2014
Primary Completion
June 2, 2015
Study Completion
June 2, 2015
Last Updated
November 27, 2017
Record last verified: 2017-11