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A Sourcing Study to Collect Human Blood Samples From Healthy Adults

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ClinicalTrials.gov Identifier: NCT03493919
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to collect large volumes of matched pairs of pre- and post-vaccination sera from healthy subjects who will be administered GlaxoSmithKline (GSK) Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine (Bexsero), which will serve for the development, qualification, validation and maintenance of immunological assays and will support the preclinical research activities and clinical development of GSK Biologicals' vaccines. The safety of the subjects given one of the 2 vaccines (Bexsero or Menveo), as per the recommended dosage and schedule will be assessed during their participation in the study.

Condition or disease Intervention/treatment Phase
Meningitis, Meningococcal Biological: Bexsero Biological: Menveo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : September 22, 2023
Estimated Study Completion Date : September 22, 2023


Arm Intervention/treatment
Experimental: rMenB+OMV NZ Group
Approximately 510 healthy subjects vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and have blood collected at Day -83, Day 8 and Day 98.
Biological: Bexsero
Two doses of Bexsero will be administered on a 0,2-month schedule (Day 1 and Day 61) intramuscularly in the upper deltoid of the non-dominant arm.

Experimental: MenACWY 1 Group
Approximately 170 healthy subjects vaccinated intramuscularly with Menveo vaccine at Day 1 and have blood collected at Day -83, Day 8 and Day 151.
Biological: Menveo
One dose of Menveo vaccine will be administered intramuscularly in the upper deltoid of the non-dominant arm, at Day 1.

Experimental: MenACWY 2 Group
Approximately 170 healthy subjects vaccinated intramuscularly with Menveo vaccine at Day 1 and have blood collected at Day -60, Day 31 and Day 151.
Biological: Menveo
One dose of Menveo vaccine will be administered intramuscularly in the upper deltoid of the non-dominant arm, at Day 1.

Experimental: MenACWY 3 Group
Approximately 170 healthy subjects vaccinated intramuscularly with Menveo vaccine at Day 1 and have blood collected at Day -30, Day 61 and Day 151.
Biological: Menveo
One dose of Menveo vaccine will be administered intramuscularly in the upper deltoid of the non-dominant arm, at Day 1.




Primary Outcome Measures :
  1. Collection of human blood for conversion into serum. [ Time Frame: At Visit 1 (Day -83) ]
    Blood samples collected from subjects who receive Bexsero vaccine or Menveo vaccine.

  2. Collection of human blood for conversion into serum. . [ Time Frame: At Visit 5 (Day 8) ]
    Blood samples collected from subjects who receive Bexsero vaccine or Menveo vaccine.

  3. Collection of human blood for conversion into serum. [ Time Frame: At Visit 8 (Day 98) ]
    Blood samples collected from subjects who receive Bexsero vaccine.

  4. Collection of human blood for conversion into serum. [ Time Frame: At Visit 9 (Day 151) ]
    Blood samples collected from subjects who receive Menveo vaccine.

  5. Collection of human blood for conversion into serum. [ Time Frame: At visit 2 (Day -60) ]
    Blood samples collected from subjects who receive Menveo vaccine

  6. Collection of human blood for conversion into serum. [ Time Frame: At Visit 6 (Day 31) ]
    Blood samples collected from subjects who receive Menveo vaccine

  7. Collection of human blood for conversion into serum. [ Time Frame: At visit 3 (Day -30) ]
    Blood samples collected from subjects who receive Menveo vaccine

  8. Collection of human blood for conversion into serum. [ Time Frame: At Visit 7 (Day 61) ]
    Blood samples collected from subjects who receive Menveo vaccine


Secondary Outcome Measures :
  1. Assessment of the occurrence of Serious Adverse Events (SAEs) related to vaccination [ Time Frame: Throughout the study period (approximately 8 months) ]
    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity in a subject or is a congenital anomaly/ birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject prior to performing any study specific procedure.
  • A male or female between, and including, 18 and 50 years of age at the time of the first study visit.
  • Healthy subjects as established by medical history and clinical examination before entering into the study. Healthy subjects 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), but not to present obesity (BMI < 32kg/m2).
  • Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination and
    • has agreed to continue adequate contraception during the entire treatment period and for 1 month, after completion of the vaccination series.

Exclusion Criteria:

  • Progressive, unstable or uncontrolled clinical conditions.
  • Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  • Abnormal function of the immune system resulting from:

    • Clinical conditions.
    • Systemic administration of corticosteroids (PO/IV/IM) within 90 days prior to informed consent.
    • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
  • Received immunoglobulins or any blood products within 180 days prior to informed consent.
  • Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
  • Any history of meningococcal vaccination or meningococcal and gonorrhoea diseases.
  • Enrolment in any activity requiring a blood donation greater than 50 mL during the period starting 30 days before the first study visit (Day -83, Day -60 or Day -30) or for the duration of the study period.
  • Administration of long-acting immune-modifying drugs at any time during the study period
  • Subjects with blood disorders.
  • Subjects with a history of difficulty in providing blood samples
  • Any antibiotic intake 7 days prior to blood collection.
  • Subjects who donated >450 mL of blood within 60 days prior to any blood collection visits.
  • Subjects who lost >200 mL during a single apheresis or who lost red blood cells on more than one occasion during apheresis within the previous 60 days.
  • 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
  • Ongoing anaemia as indicated by haemoglobin values below the lower limit of the laboratory-specified reference range. If the finger prick method demonstrates an anaemia, 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 anaemia has been resolved.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination
  • Family history of congenital or hereditary immunodeficiency.
  • Serious chronic illness.
  • History of chronic alcohol consumption and/or drug abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493919


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Australia, New South Wales
GSK Investigational Site Recruiting
Sydney, New South Wales, Australia, 2010
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mark Bloch         
Australia, South Australia
GSK Investigational Site Recruiting
Adelaide, South Australia, Australia, 5000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Angela Molga         
Australia, Victoria
GSK Investigational Site Recruiting
Geelong, Victoria, Australia, 3220
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Eugene Athan         
GSK Investigational Site Recruiting
Melbourne, Victoria, Australia, 3004
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Janet Wong         
Australia, Western Australia
GSK Investigational Site Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Peter R Bremner         
Germany
GSK Investigational Site Recruiting
Wuerzburg, Bayern, Germany, 97070
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Tino F Schwarz         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03493919     History of Changes
Other Study ID Numbers: 207911
2017-002919-33 ( EudraCT Number )
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by GlaxoSmithKline:
Immunological assays
Human blood donors
Meningococcal vaccination
Meningococcal disease
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs