Assessing Contacts' Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation

NCT ID: NCT01890447

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 676 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-02-29

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.

Conditions

Pertussis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Questionnaire design group

A focus group (group of experts) such as physicians, nurses, or other professionals invited by the investigator.

Web-based survey questionnaire

Intervention Type: OTHER

Data collection will be done via web-based questionnaires generated by Sawtooth Software. Subjects will be asked for their ideal alternative (acceptance to immunisation) by selecting the factors that suit them the most. The subjects are then presented several sets of alternatives built around their ideal choice.

Adaptive questionnaire group

Adults who are contacts of newborns or expecting mothers in their last trimester of pregnancy or their partners. The data of the subjects in this group will be analysed using the adaptive choice based conjoint (ACBC) technique.

Web-based survey questionnaire

Intervention Type: OTHER

Data collection will be done via web-based questionnaires generated by Sawtooth Software. Subjects will be asked for their ideal alternative (acceptance to immunisation) by selecting the factors that suit them the most. The subjects are then presented several sets of alternatives built around their ideal choice.

Standard questionnaire group

Adults who are contacts of newborns or expecting mothers in their last trimester of pregnancy or their partners. The data of the subjects in this group will be analysed using the standard discrete choice experiment (DCE) technique.

Web-based survey questionnaire

Intervention Type: OTHER

Data collection will be done via web-based questionnaires generated by Sawtooth Software. Subjects will be asked for their ideal alternative (acceptance to immunisation) by selecting the factors that suit them the most. The subjects are then presented several sets of alternatives built around their ideal choice.

Interventions

Web-based survey questionnaire

Data collection will be done via web-based questionnaires generated by Sawtooth Software. Subjects will be asked for their ideal alternative (acceptance to immunisation) by selecting the factors that suit them the most. The subjects are then presented several sets of alternatives built around their ideal choice.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

San Severo (FG), Apulia, Italy

GSK Investigational Site

Chiavari, Liguria, Italy

GSK Investigational Site

Cuneo, Piedmont, Italy

GSK Investigational Site

Ragusa (RG), Sicily, Italy

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Getafe/Madrid, , Spain

GSK Investigational Site

Leioa( Vizcaya), , Spain

GSK Investigational Site

Pamplona, , Spain

GSK Investigational Site

Parla, , Spain

Countries

Italy; Spain

Other Identifiers

116964

Identifier Type: -

Identifier Source: org_study_id