Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaire design group | A focus group (group of experts) such as physicians, nurses, or other professionals invited by the investigator. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Severo (FG) | Apulia | 71016 | Italy | ||
| GSK Investigational Site |
Not provided
| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Chiavari |
| Liguria |
| 16043 |
| Italy |
| GSK Investigational Site | Cuneo | Piedmont | 12100 | Italy |
| GSK Investigational Site | Ragusa (RG) | Sicily | 97100 | Italy |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Getafe/Madrid | 28905 | Spain |
| GSK Investigational Site | Leioa( Vizcaya) | 48940 | Spain |
| GSK Investigational Site | Pamplona | 31008 | Spain |
| GSK Investigational Site | Parla | 28982 | Spain |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |