Influenza Vaccine, InfluenzaNCT02909855
Factors Associated With Parental Observation of Side Effects Following the Child Flu Vaccine
An observational study of Influenza Vaccine, Influenza, run by King's College London at 11 sites in United Kingdom.
Trial summary
This study investigates whether there are psychological predictors of parental perception of side-effects following vaccination with the child flu vaccine. We will also investigate whether the perception of side-effects affects parents' intention to vaccinate their child again in the following flu season, as well as… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine, Influenza
- Type of treatment
- Vaccines
- How many people
- 270 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- Oct 2016to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Parents of guardians of children aged 2-4 on 31st August 2016 (i.e. born September 1st 2011 to August 31st 2014) who receive the flu vaccine at the GP * Parents must be aged 18 or over * Parents must be fluent in English
Who may be able to join
- Parents of guardians of children aged 2-4 on 31st August 2016 (i.e. born September 1st 2011 to August 31st 2014) who receive the flu vaccine at the GP
- Parents must be aged 18 or over
- Parents must be fluent in English
Who cannot join
- -
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites
Albion Street Group Practice
London
Claremont Medical Centre
London
Herne Hill Group Practice
London
Honor Oak Group Practice
London
Hurley Clinic
London
Links Medical Practice
London
Morden Hall Medical Centre
London
Park Group Practice
London
Paxton Green Group Practice
London
The Rosendale Surgery
London
Woodlands Practice
London
About this study
This study investigates whether there are psychological predictors of parental perception of side-effects following vaccination with the child flu vaccine. We will also investigate whether the perception of side-effects affects parents' intention to vaccinate their child again in the following flu season, as well as whether there are underlying differences in parents' cognitive biases between those who do and do not re-vaccinate their child.
Read the detailed description
In 2012, the British Joint Committee on Vaccination and Immunisation (JCVI) recommended that the influenza vaccination programme be extended to include children aged 2 to 16. In the three flu seasons in which the child flu immunisation programme has been running (2013-14, 2014-15, 2015-16), uptake rates have been low (approximately 40%). Multiple factors are likely to underlie the poor uptake, including thinking the vaccine was unsafe and ineffective and having experienced side-effects related to the vaccine previously.
Although symptoms are commonly reported following vaccinations, their causes are not always straightforward. Although a minority may be directly attributable to the vaccine itself, others may reflect pre-existing or coincidental symptoms that are misattributed to the vaccine. Following vaccination, an expectation that the vaccine causes side-effects may also contribute to parents detecting symptoms in their child that might otherwise have gone unnoticed. Perception of side-effects may also influence the parent's decision to vaccinate their child again in following years.
Other possible factors influencing parents' perception of side-effects and their willingness to vaccinate their child again are their personal health beliefs and their interpretations of the information they are given about vaccination and side-effects. These cognitive processes can be measured objectively using experimental tasks, and can reveal characteristic patterns, or 'cognitive biases' which govern behaviour.
- Conditions
- Influenza Vaccine, Influenza
- Being tested
- No intervention
- Keywords
- children, psychological predictors, side-effects, vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Participants in this study will not receive any interventions as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Parents of children aged 2-4 who will receive the child flu vaccine from their general practitioner (GP) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who perceive their child to have treatment-related adverse events from the child flu vaccine
Using questionnaire materials as a method of assessment
Measured: October 2016 - March 2017
Secondary outcomes (2)
Intention to re-vaccinate child
Using a scale as a method of assessment
Measured: October 2016 - March 2017
Negative interpretative bias scores as assessed by the scrambled sentences and similarity ratings tasks
Measured: October 2016 - March 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza Vaccine, InfluenzaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G James Rubin, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909855
- Sponsor's protocol ID
- 16/LO/1003
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Smith LE, Amlot R, Weinman J, Yiend J, Rubin GJ. Why do parents not re-vaccinate their child for influenza? A prospective cohort study. Vaccine. 2020 Jun 2;38(27):4230-4235. doi: 10.1016/j.vaccine.2020.04.029. Epub 2020 May 5.
PubMed 32386745Smith LE, Weinman J, Amlot R, Yiend J, Rubin GJ. Parental Expectation of Side Effects Following Vaccination Is Self-fulfilling: A Prospective Cohort Study. Ann Behav Med. 2019 Mar 1;53(3):267-282. doi: 10.1093/abm/kay040.
PubMed 29868792
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Parental Observation of Side Effects Following the Child Flu Vaccine
- ClinicalTrials.gov ID
- NCT02909855
- Acronym / sponsor ID
- 16/LO/1003
- Conditions
- Influenza Vaccine, Influenza
- Keywords
- children, psychological predictors, side-effects, vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether there are psychological predictors of parental perception of side-effects following vaccination with the child flu vaccine. We will also investigate whether the perception of side-effects affects parents' intention to vaccinate their child again in the following flu season, as well as whether there are underlying differences in parents' cognitive biases between those who do and do not re-vaccinate their child.
Detailed description
In 2012, the British Joint Committee on Vaccination and Immunisation (JCVI) recommended that the influenza vaccination programme be extended to include children aged 2 to 16. In the three flu seasons in which the child flu immunisation programme has been running (2013-14, 2014-15, 2015-16), uptake rates have been low (approximately 40%). Multiple factors are likely to underlie the poor uptake, including thinking the vaccine was unsafe and ineffective and having experienced side-effects related to the vaccine previously.
Although symptoms are commonly reported following vaccinations, their causes are not always straightforward. Although a minority may be directly attributable to the vaccine itself, others may reflect pre-existing or coincidental symptoms that are misattributed to the vaccine. Following vaccination, an expectation that the vaccine causes side-effects may also contribute to parents detecting symptoms in their child that might otherwise have gone unnoticed. Perception of side-effects may also influence the parent's decision to vaccinate their child again in following years.
Other possible factors influencing parents' perception of side-effects and their willingness to vaccinate their child again are their personal health beliefs and their interpretations of the information they are given about vaccination and side-effects. These cognitive processes can be measured objectively using experimental tasks, and can reveal characteristic patterns, or 'cognitive biases' which govern behaviour.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: No interventionParents of children aged 2-4 who will receive the child flu vaccine from their general practitioner (GP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Parents of guardians of children aged 2-4 on 31st August 2016 (i.e. born September 1st 2011 to August 31st 2014) who receive the flu vaccine at the GP * Parents must be aged 18 or over * Parents must be fluent in English
Key inclusion criteria (3 listed)
- Parents of guardians of children aged 2-4 on 31st August 2016 (i.e. born September 1st 2011 to August 31st 2014) who receive the flu vaccine at the GP
- Parents must be aged 18 or over
- Parents must be fluent in English
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionParticipants in this study will not receive any interventions as part of the study. | Other | Participants |
Primary outcome
Number of participants who perceive their child to have treatment-related adverse events from the child flu vaccine
Time frame: October 2016 - March 2017
Using questionnaire materials as a method of assessment
2 secondary outcomes
Intention to re-vaccinate child
Time frame: October 2016 - March 2017
Negative interpretative bias scores as assessed by the scrambled sentences and similarity ratings tasks
Time frame: October 2016 - March 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 32386745Smith LE, Amlot R, Weinman J, Yiend J, Rubin GJ. Why do parents not re-vaccinate their child for influenza? A prospective cohort study. Vaccine. 2020 Jun 2;38(27):4230-4235. doi: 10.1016/j.vaccine.2020.04.029. Epub 2020 May 5.
- Derived from this study: PubMed 29868792Smith LE, Weinman J, Amlot R, Yiend J, Rubin GJ. Parental Expectation of Side Effects Following Vaccination Is Self-fulfilling: A Prospective Cohort Study. Ann Behav Med. 2019 Mar 1;53(3):267-282. doi: 10.1093/abm/kay040.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G James Rubin, PhD principal investigator
King's College London
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Vaccine, Influenza, run by King's College London at 11 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who perceive their child to have treatment-related adverse events from the child flu vaccine (time frame: October 2016 - March 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.