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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Immunization; Infection

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

External Links

•   Common Genetic Variations Associated with the Persistence of Immunity following Childhood Immunization
•   Related Info