Coverage Rate of Vaccination for InfluenzaNCT03007797
Realization of the Recommendation for Influenza Vaccination in Pregnant Women
An observational study of Coverage Rate of Vaccination for Influenza, run by University Hospital, Saarland.
Trial summary
Introduction: In 2010, the vaccination recommendations for pregnant women against seasonal influenza were published by the German Standing Committee on Vaccination (STIKO). This work deals with the immunization coverage and the influencing factors. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Coverage Rate of Vaccination for Influenza
- What is being tested?
- vaccination rate for influenza
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Feb 2014
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 236 pregnant women in 2 centers
Who may be able to join
- pregnant women older than 18
- vaccination records
- signatetd letter of agreement
Who cannot join
- younger than 18
About this study
Official title: Women - Influencing Factors and Coverage Rate
Introduction:
In 2010, the vaccination recommendations for pregnant women against seasonal influenza were published by the German Standing Committee on Vaccination (STIKO). This work deals with the immunization coverage and the influencing factors.
Read more
Method:
A cross-sectional study was realized at two Level 1 perinatal centers in two German federal states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed by using a standardized and pre-tested questionnaire covering their knowledge about the influenza vaccination and other factors influencing the vaccination decision. Furthermore, data from the vaccination card and the pregnancy record booklet have been evaluated.
- Being tested
- vaccination rate for influenza
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccination rate for influenzaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| vaccination rate- pregnant- influenca | Not described Receives: Behavioral: vaccination rate for influenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza Vaccination rate in Pregnant Women
The first aim of the study is check how many pregnant women are following the new german recommendation of influenza vaccination in pregnancy.
Measured: 02/12- 02/14
Secondary outcomes (1)
influencing factors on the Influenza vaccination rate
Second aim is to investigate the factors which are influencing the decission for or against the influenza vaccination in pregnancy.
Measured: 02/12- 02/14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startDec 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coverage Rate of Vaccination for InfluenzaStudies of the same condition, open and under way.
- 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Worms
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007797
- Sponsor's protocol ID
- homwo 01
- Status last verified
- Dec 2016
- First submitted
- 7 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women - Influencing Factors and Coverage Rate
- ClinicalTrials.gov ID
- NCT03007797
- Acronym / sponsor ID
- homwo 01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Collaborators
- Klinikum Worms
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Jan 2017 (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.
Introduction:
In 2010, the vaccination recommendations for pregnant women against seasonal influenza were published by the German Standing Committee on Vaccination (STIKO). This work deals with the immunization coverage and the influencing factors.
Method:
A cross-sectional study was realized at two Level 1 perinatal centers in two German federal states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed by using a standardized and pre-tested questionnaire covering their knowledge about the influenza vaccination and other factors influencing the vaccination decision. Furthermore, data from the vaccination card and the pregnancy record booklet have been evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccination rate- pregnant- influenca | – | Behavioral: vaccination rate for influenza |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 236 pregnant women in 2 centers
Key inclusion criteria (3 listed)
- pregnant women older than 18
- vaccination records
- signatetd letter of agreement
Key exclusion criteria (1 listed)
- younger than 18
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 |
|---|---|---|
| vaccination rate for influenza | Behavioural | vaccination rate- pregnant- influenca |
Primary outcome
Influenza Vaccination rate in Pregnant Women
Time frame: 02/12- 02/14
The first aim of the study is check how many pregnant women are following the new german recommendation of influenza vaccination in pregnancy.
1 secondary outcome
influencing factors on the Influenza vaccination rate
Time frame: 02/12- 02/14
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 2 Jan 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coverage Rate of Vaccination for Influenza, run by University Hospital, Saarland.
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 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Influenza Vaccination rate in Pregnant Women (time frame: 02/12- 02/14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2017.