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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01890447
First received: June 20, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Pertussis
Other: Web-based survey questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessing Contacts' Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation, in Italy and Spain

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    The primary endpoint constitutes the answers collected from all conjoint sections of the adaptive web-based questionnaire.


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Answers from the two parents (same couple) may be identified for comparison purposes and joint analysis.


Estimated Enrollment: 700
Study Start Date: November 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
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.
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
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890447

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01890447     History of Changes
Other Study ID Numbers: 116964
Study First Received: June 20, 2013
Last Updated: July 3, 2014
Health Authority: Spain: AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS (AEMPS)

Keywords provided by GlaxoSmithKline:
Cocooning
Web-based questionnaire
Italy
Pertussis
Spain
Survey

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014