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NCT03145324 Clinical Trial

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

Immunization; Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03145324
Other study ID # OVG 2012/08
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2013
Est. completion date October 2016

Study information
Verified date May 2017
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date October 2016
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - The inclusion criteria are consent in the original vaccine study (09/H0604/107) with explicit consent for samples to be stored and used in future research as well as consent to this subsequent study 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Collection of vaccine histories

Locations
Country Name City State
United Kingdom Centre for Clinical Vaccinology & Tropical Medicine (CCVTM) Oxford Oxfordshire

Sponsors (1)
Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoint will be the completion of the collection of vaccination histories from consented participants. 1 year
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