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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Assessing Contacts' Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation, in Italy and Spain

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 Summary:

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.


Sponsor: GlaxoSmithKline

Current Primary Outcome: 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. [ Time Frame: After completion of the questionnaire by all the subjects (Visit 1 i.e. Day 0). ]

The primary endpoint constitutes the answers collected from all conjoint sections of the adaptive web-based questionnaire.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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. [ Time Frame: After completion of the questionnaire by all the subjects (Visit 1 i.e. Day 0). ]

Answers from the two parents (same couple) may be identified for comparison purposes and joint analysis.


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: June 20, 2013
Date Started: January 2015
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017