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A Sourcing Study to Collect Human Blood Samples From Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Sourcing Study to Collect Human Blood Samples From Healthy Adults

A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults

NCT03493919•GlaxoSmithKline

Summary

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

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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.
+17 more criteria

Locations (6)

GSK Investigational Site

Sydney, New South Wales, Australia

GSK Investigational Site

Adelaide, South Australia, Australia

GSK Investigational Site

Geelong, Victoria, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Spearwood, Western Australia, Australia

GSK Investigational Site

Würzburg, Bavaria, Germany

Key Dates

Start Date

March 8, 2018

Primary Completion Date

May 27, 2022

Completion Date

May 27, 2022

Last Updated

July 17, 2023

Enrollment

1,021

ACTUAL participants

Conditions

Meningitis, Meningococcal

Interventions

rMenB+OMV NZ vaccine

BIOLOGICAL

Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)

BIOLOGICAL

Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

NCT05252715

Meningitis, Meningococcal

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TERMINATEDNA

A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

NCT03549325

Meningitis, Meningococcal

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COMPLETEDPHASE3

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Sourcing Study to Collect Human Blood Samples From Healthy Adults

Inclusion Criteria

Exclusion Criteria

Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

A Study Assessing Colonisation & Immunogenicity After Nasal Inoculation With N. Lactamica and Eradication on Day 4 or 14

RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants