Immunisation History Survey - a Study to Measure Levels of Immunity to Routine Immunisations

NCT ID: NCT03145324

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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To collect the immunisation history of participants enrolled in a previous vaccine study (REC 09/H0604/107) in order to assess the influence of genetic variation on the level of immunity to routine immunisations.

Detailed Description

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Children aged 6 month to 13 years were enrolled in a study to compare the immunogenicity and safety of adjuvanted or non-adjuvanted influenza vaccines during the 2009 pandemic influenza season. Nine-hundred and forty-nine children were recruited from 5 UK centres: Oxford, Southampton, Bristol, Exeter, and London

In the previous study, DNA was collected when individuals provided appropriate consent, to explore the genetic determinants of responses to vaccination. Although, study participants consented for their medical records to be reviewed by members of the study team, and for these data as well as anonymised serum samples to be used in future research, routine immunisation histories were not collected before this study closed.

In this study we wish to collect the full vaccination history of participants, as this information will be extremely important in interpreting results. We propose sending a letter to parents/guardians informing them of the study and asking whether they are willing for members of the study team to approach their general practitioner or the child health computer system in order to retrieve these records. Immunisation histories will then be included with other non-identifiable information needed for analysis, and samples unlinked from personal identifiers prior to analysis.

Conditions

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Immunization; Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Collection of vaccine histories

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Individuals who do not have explicit consent for samples taken in the original vaccine study (09/H0604/107) to be stored for future research.
* Individuals who have not been consented into this study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Pollard Pollard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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OVG 2012/08

Identifier Type: -

Identifier Source: org_study_id

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