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OpenTrials
Completed

NCT Number: NCT03145324

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)

Oxford, Oxfordshire, OX1 4LE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of vaccine histories

Other

Primary outcomes

  1. The primary endpoint will be the completion of the collection of vaccination histories from consented participants.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
May 9, 2017
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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