NCT03007797

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

December 7, 2016

Last Update Submit

December 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    02/12- 02/14

Secondary Outcomes (1)

  • influencing factors on the Influenza vaccination rate

    02/12- 02/14

Study Arms (1)

vaccination rate- pregnant- influenca

Behavioral: vaccination rate for influenza

Interventions

vaccination rate- pregnant- influenca

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

236 pregnant women in 2 centers

You may qualify if:

  • pregnant women older than 18
  • vaccination records
  • signatetd letter of agreement

You may not qualify if:

  • younger than 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2016

First Posted

January 2, 2017

Study Start

December 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 2, 2017

Record last verified: 2016-12