PRIME Follow up - Quadri Meningo Vacinees

NCT02811120 | Completed

• 1 other identifier: PRIMEfollowup
• Study Type: observational
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Meningococcal Disease

Keywords

meningococcal; conjugate; vaccine; quadrivalent; meningococcal quadrivalent conjugate vaccine

Outcome Measures

Primary Outcomes (1)

• Serum bactericidal antibody (SBA) assays

  Strains C11, F8238, M01 240070, M03 241125

  single timepoint per participant, within the 12 month study timeframe

Study Arms (1)

single arm

single venepuncture

Other: venepuncture only

Interventions

venepuncture only OTHER

single venepuncture

single arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Health volunteers who previously took part in a clinical trial of meningococcal quadrivalent vaccine

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health England: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serology samples

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Elizabeth Coates, PhD

  Public Health England

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 23, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 3, 2020

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share