Phase 4
N=961
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
Meningitis, Meningococcal
Bottom Line
View on ClinicalTrials.gov: NCT03493919 ↗Enrolled (actual)
961
Serious AEs
0.5%
Results posted
Jul 2023
Primary outcome: Primary: Number of Human Blood Samples Collected for Conversion Into Serum at Day -83 — 5578; 1936 Blood samples
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rMenB+OMV NZ vaccine (Biological); Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Human Blood Samples Collected for Conversion Into Serum at Day -83 |
5578; 1936 | — |
| PRIMARY Number of Human Blood Samples Collected for Conversion Into Serum at Day 8 |
5396; 1907 | — |
| PRIMARY Number of Human Blood Samples Collected for Conversion Into Serum at Day 98 |
5204 | — |
| PRIMARY Number of Human Blood Samples Collected for Conversion Into Serum at Day 151 |
1869; 1866; 1752 | — |
| PRIMARY Number of Human Blood Samples Collected for Conversion Into Serum at Day -60 |
1957 | — |
| PRIMARY Number of Human Blood Samples Collected for Conversion Into Serum at Day 31 |
1920 | — |
| PRIMARY Number of Human Blood Samples Collected for Conversion Into Serum at Day-30 |
1894 | — |
| PRIMARY Number of Human Blood Samples Collected for Conversion Into Serum at Day 61 |
1809 | — |
| SECONDARY Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination |
0; 0; 0; 0 | — |
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 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 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.
Data sourced from ClinicalTrials.gov (NCT03493919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.