A Protocol to Collect Human Serum Samples From Healthy Adults for Use as Quality Controls Samples in GlaxoSmithKline (GSK) Biologicals' Assays
NCT ID: NCT02072525
Last Updated: 2017-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
359 participants
INTERVENTIONAL
2014-04-01
2015-06-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Subjects 18 through 49 years of age (have not yet achieved 50th birthday) will be randomized to receive Menveo + Boostrix and subjects 50 to 55 years of age will be randomized to receive either Pneumovax 23 or Prevnar 13 and will serve as donors of human serum in this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mtdap1 Group
Subjects will receive concomitant doses of Menveo and Boostrix.
Menveo®
One dose administered intramuscularly (IM) in the upper left deltoid of the arm.
Boostrix®
One dose administered intramuscularly (IM) in the upper right deltoid of the arm.
Mtdap2 Group
Subjects will receive concomitant doses of Menveo and Boostrix.
Menveo®
One dose administered intramuscularly (IM) in the upper left deltoid of the arm.
Boostrix®
One dose administered intramuscularly (IM) in the upper right deltoid of the arm.
Mtdap3 Group
Subjects will receive concomitant doses of Menveo and Boostrix.
Menveo®
One dose administered intramuscularly (IM) in the upper left deltoid of the arm.
Boostrix®
One dose administered intramuscularly (IM) in the upper right deltoid of the arm.
Pneum1 Group
Subjects will receive a dose of Pneumovax 23.
Pneumovax 23®
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Pneum2 Group
Subjects will receive a dose of Pneumovax 23.
Pneumovax 23®
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Pneum 3 Group
Subjects will receive a dose of Pneumovax 23.
Pneumovax 23®
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Prev1 Group
Subjects will receive a dose of Prevnar 13.
Prevnar 13®
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Prev2 Group
Subjects will receive a dose of Prevnar 13.
Prevnar 13®
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Prev3 Group
Subjects will receive a dose of Prevnar 13.
Prevnar 13®
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Menveo®
One dose administered intramuscularly (IM) in the upper left deltoid of the arm.
Boostrix®
One dose administered intramuscularly (IM) in the upper right deltoid of the arm.
Pneumovax 23®
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Prevnar 13®
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Serious chronic illness.
* Acute disease and/or fever at the time of vaccination (Day 0).
* Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be oral.
* Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* History of chronic alcohol consumption and/or drug abuse.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary) based on medical history and history directed physical examination (no laboratory testing at the screening visit is required).
* Previous vaccination against diphtheria and/or tetanus within the past 5 years and/or Neisseria meningitidis since birth.
* Progressive neurological disorders, including uncontrolled epilepsy or progressive encephalopathy.
* Subjects who have experienced an encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with a pertussis containing vaccine.
* Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus.
* If any of the following events had occurred in temporal relation to previous administration of whole-cell DTP or acellular DTP vaccine:
* Temperature of ≥ 40.0°C within 48 hours of vaccination, not due to another identifiable cause.
* Collapse or shock like state (hypotonic hyporesponsive episode) within 48 hours of vaccination.
* Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
* Convulsions with or without fever, occurring within 3 days of vaccination.
Additional exclusions criterion for subjects 50-55 years of age
• Previous vaccination against Streptococcus pneumoniae.
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
200612
Identifier Type: -
Identifier Source: org_study_id