Clinical trial NCT01890447: Assessing Contacts' Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation
Official title: Assessing Contacts' Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation, in Italy and Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertussis
Keywords: Cocooning
Web-based questionnaire
Italy
Pertussis
Spain
Survey
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-07-01
Enrollment: 676
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 18 years and above 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.

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 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.

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 final web-based questionnaires to the subjects included in the enrollment phase.

The data generated in this study will be useful to inform parents of newborns about the advantages of vaccinating people who are in close contact with the newborn even before the baby is born in order to prevent the transmission of pertussis to the newborn.

No vaccine will be administered during this study.

Eligibility 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).

Primary outcomes:
measure: 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:
measure: 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).
Other outcomes:
Locations:
city: Chiavari
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Cuneo
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: San Severo (FG)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Ragusa (RG)
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Getafe/Madrid
country: Spain
facility: GSK Investigational Site
city: Leioa( Vizcaya)
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: Parla
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: