Meningococcal Disease Clinical Trial
— PRIMEfollowupOfficial title:
An Observational Follow up Study of a Phase II/III, Open Label, Randomised Study of the Safety, Reactogenicity and Immunogenicity of a Single Dose of Meningococcal ACWY Conjugate Vaccine (Menveo, Glaxosmithkline or Nimenrix, Pfizer) in Adolescents Who Were Primed With Meningitec, Menjugate or Neisvac-C During Preschool Vaccination
NCT number | NCT02811120 |
Other study ID # | PRIMEfollowup |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | December 2017 |
Verified date | August 2018 |
Source | Public Health England |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A previous cohort of 93 clinical trial participants received quadrivalent meningococcal
conjugate vaccine, which includes strains ACW and Y, in their teenage years. The vaccine also
contains components of diphtheria and tetanus which are linked to the meningitis components,
in a process called conjugation, to improve their effectiveness.
Participants are now aged 19-25 and will be invited to take part in this study, which will
assess antibody persistence over time. This will provide information about the duration of
protection by relating current antibody levels to those measured in the previous study, and
will underpin the national immunisation schedule in providing optimal immunisation schedule.
As well as the meningitis antibodies the investigators will assess diphtheria and tetanus
antibody levels.
The study will involve a single blood test of up to 8mL. Participants will be informed of
their results and any with an antibody level that does not infer protection against strain W
will be offered an extra dose of vaccine as part of a duty of care.
The study will involve a single blood test of up to 8mL. Participants will be informed of
their results and any with an antibody level that does not infer protection against strain W
will be offered an extra dose of vaccine.
Status | Completed |
Enrollment | 57 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Individual is willing and able to give written informed consent for participation. - Individual was originally enrolled in the randomised parallel group study of quadrivalent meningococcal vaccination. Exclusion Criteria: - Known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time). - Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Public Health England |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum bactericidal antibody (SBA) assays | Strains C11, F8238, M01 240070, M03 241125 | single timepoint per participant, within the 12 month study timeframe |
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