Last updated: 08/13/2019 19:20:08

Assessing contacts’ decision making on reducing the risk of pertussis transmission to newborns through immunisation

GSK study ID
116964
See study documents
Clinicaltrials.gov ID
NCT01890447
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Assessing contacts’ decision making on reducing the risk of pertussis transmission to newborns through immunisation, in Italy and Spain
Trial description: 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 strategy (vaccinating those who are in close contact with the newborn) by assessing the factors that affect the parents’ decision-making to accept pertussis immunisation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The standard choice-based data will be used to assess the quality of the model fitted using the adaptive data. It will also be used for a qualitative comparison of adaptive (ACBC) and standard (CBC) data collection using descriptive approach.

Timeframe: After completion of the questionnaire by all the subjects (Visit 1 i.e. Day 0).

Secondary outcomes:

The secondary endpoints constitute in all, the non-conjoint ancillary data collected through the web-based fixed questionnaire including, but not limited to: gender, age, family composition, education level and ethnicity.

Timeframe: After completion of the questionnaire by all the subjects (Visit 1 i.e. Day 0).

Interventions:
Other: Web-based survey questionnaire
Enrollment:
725
Observational study model:
Cohort
Primary completion date:
2016-01-02
Time perspective:
Cross-Sectional
Clinical publications:
Ledent E et al. (2019) Attributes influencing parental decision-making to receive the Tdap vaccine to reduce the risk of pertussis transmission to their newborn - outcome of a cross-sectional conjoint experiment in Spain and Italy. Hum Vaccin Immunother. 15(5):1080-1091. doi: 10.1080/21645515.2019.1571890.
Medical condition
Pertussis
Product
SB263855
Collaborators
Not applicable
Study date(s)
January 2015 to February 2016
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
  • 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 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.
Inclusion and exclusion criteria
Inclusion criteria:

    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 criteria:

    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).

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Barcelona, Spain, 08035
Status
Study Complete
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Location
GSK Investigational Site
Chiavari, Liguria, Italy, 16043
Status
Study Complete
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Location
GSK Investigational Site
Cuneo, Piemonte, Italy, 12100
Status
Study Complete
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Location
GSK Investigational Site
Getafe/Madrid, Spain, 28905
Status
Study Complete
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Location
GSK Investigational Site
Leioa( Vizcaya), Spain, 48940
Status
Study Complete
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Location
GSK Investigational Site
Pamplona, Spain, 31008
Status
Study Complete
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Location
GSK Investigational Site
Parla, Spain, 28982
Status
Study Complete
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Location
GSK Investigational Site
Ragusa (RG), Sicilia, Italy, 97100
Status
Study Complete
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Location
GSK Investigational Site
San Severo (FG), Puglia, Italy, 71016
Status
Study Complete
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Study documents

Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Clinical study report
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2016-01-02
Actual study completion date
2016-01-02

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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