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

NCT01890447 | Completed

• 1 other identifier: 116964
• Study Type: observational
• Target: 676
• Locations: 2 countries
• Sites: 9

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.

Conditions

Pertussis

Keywords

Cocooning; Web-based questionnaire; Italy; Pertussis; Spain; Survey

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

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

Study Arms (3)

Questionnaire design group

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

Other: Web-based survey questionnaire

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.

Other: Web-based survey questionnaire

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.

Other: Web-based survey questionnaire

Interventions

Web-based survey questionnaire 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; Questionnaire design group; Standard questionnaire group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (9)

GSK Investigational Site

San Severo (FG), Apulia, 71016, Italy

Location

GSK Investigational Site

Chiavari, Liguria, 16043, Italy

Location

GSK Investigational Site

Cuneo, Piedmont, 12100, Italy

Location

GSK Investigational Site

Ragusa (RG), Sicily, 97100, Italy

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Getafe/Madrid, 28905, Spain

Location

GSK Investigational Site

Leioa( Vizcaya), 48940, Spain

Location

GSK Investigational Site

Pamplona, 31008, Spain

Location

GSK Investigational Site

Parla, 28982, Spain

Location

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: July 1, 2013
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

IT (4); ES (5)