Status:
COMPLETED
Assessing Contacts' Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pertussis
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to establish an effective method to inform parents or close relatives of newborns about the risk of pertussis transmission to newborns and the advantages offered by the cocooning strat...
Detailed Description
Two phases are foreseen in the study. The 'questionnaire design' phase will be conducted in order to finalise the electronic questionnaire. The enrollment phase will involve the administration of the ...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that, can and will comply with the requirements of this protocol (ability to understand the study objectives and the questions asked, and ability to operate a computer).
- Written informed consent obtained from the subject.
- Subjects aged ≥ 18 years at the time of study start who are either:
- Contacts of newborns (aged ≤ 6 months). OR Expecting mothers in their last trimester of pregnancy or their partners, who will be in close contact with the newborn.
- • Subjects who will be eligible for pertussis booster vaccination and have not received any pertussis vaccination in the last 2 years (before study start).
Exclusion
- Subjects who have participated in the 'questionnaire design' phase (applicable only for subjects who will participate in the enrollment phase of the study).
- Subjects with a contraindication to pertussis vaccination.
- Subjects who declare to be in principle against vaccination.
- Subjects who declare to be in a chronic physical condition and not compatible with vaccination.
- Subjects with a history of pertussis in the last 5 years (before study start).
- History of non-response to pertussis vaccination.
- Subjects with mental deficiency.
- Subjects with unstable chronic health condition(s).
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
676 Patients enrolled
Trial Details
Trial ID
NCT01890447
Start Date
January 1 2015
End Date
February 1 2016
Last Update
January 18 2017
Active Locations (9)
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1
GSK Investigational Site
San Severo (FG), Apulia, Italy, 71016
2
GSK Investigational Site
Chiavari, Liguria, Italy, 16043
3
GSK Investigational Site
Cuneo, Piedmont, Italy, 12100
4
GSK Investigational Site
Ragusa (RG), Sicily, Italy, 97100