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About
MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries.
The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.
Enrollment
Sex
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Volunteers
Inclusion criteria
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
Written informed assent obtained for subjects below legal age of consent, if required by local regulations at the time of the enrolment.
A male or female ≥10 to ≤40 YoA at the time of the vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion criteria
Child in care
Anaphylaxis following the administration of vaccine.
Any (clinical) condition that in the judgment of the investigator would make intramuscular injection unsafe &/represents a contraindication to intramuscular vaccination and blood draws.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
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.
Hypersensitivity to the active substances or to any of the excipients of the vaccine, including diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components.
Abnormal function of the immune system resulting from:
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.
History of any meningococcal vaccination, with the exception of previous meningococcal C vaccination, if the last dose of MenC was received at ≤24 months of age.
Individuals who received any other vaccines within 7 days (for inactivated vaccines) or 14 days prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.*
* In case an emergency mass vaccination for an unforeseen public health threat is organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its Prescribing Information and according to the local governmental recommendations and provided a written approval of the sponsor is obtained.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
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 (pharmaceutical product or device).
Current or previous, confirmed or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days prior to study vaccination.
Acute disease and/or fever within 3 days prior to study vaccination. Note: enrolment may be postponed/delayed until such transient circumstances have ended.
Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
Study personnel as an immediate family or household member.
Pregnant or lactating women.
Primary purpose
Allocation
Interventional model
Masking
1,707 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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