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

Pertussis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890447
• Other study ID #: 116964
• Status: Completed
• Phase: N/A
• First received: June 20, 2013
• Last updated: January 16, 2017
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 676
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	GSK Investigational Site	Chiavari	Liguria
Italy	GSK Investigational Site	Cuneo	Piemonte
Italy	GSK Investigational Site	Ragusa (RG)	Sicilia
Italy	GSK Investigational Site	San Severo (FG)	Puglia
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The primary endpoint constitutes the answers collected from all conjoint sections of the adaptive web-based questionnaire.	After completion of the questionnaire by all the subjects (Visit 1 i.e. Day 0).
Secondary	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.	Answers from the two parents (same couple) may be identified for comparison purposes and joint analysis.	After completion of the questionnaire by all the subjects (Visit 1 i.e. Day 0).