Tdap Vaccination for Infant Caregivers | NCT01233401

Studies
Tdap Vaccination for Infant Caregivers

NCT01233401

Sponsor

Yale University

Status

Completed

Last Update Posted

Jul 28, 2011Estimated

Enrollment

102Actual

Phase

Not provided

Conditions

Pertussis
Vaccination

Interventions

Survey

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Jun 2011Actual

First Submitted Date

Nov 1, 2010

First Submission Date that Met QC Criteria

Nov 1, 2010

First Posted Date

Nov 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2011

Last Update Posted Date

Jul 28, 2011Estimated

Name	Class
Saint Raphael Healthcare System	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates whether offering Tetanus, diphteria and acellular pertussis (Tdap) vaccine to caregivers of newborn infants during pediatric well child visits increase the caregivers' vaccination rates.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mothers			Other: Survey
Other Infant Caregivers		Includes fathers, grandparents, and other adults who are infant caregivers	Other: Survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	Mothers and Other infant caregivers are surveyed at the end of the 2 week newborn well child visit about whether they chose to receive the Tdap vaccine at the pediatrician's office.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maternal Tdap Vaccination Rate		At 2 week well child visit

Secondary Outcomes

Measure	Description	Time Frame
Other Infant Caregiver Tdap Vaccination Rate		At 2 week well child visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-64 years old
English or Spanish speaking

Exclusion Criteria:

Do not speak English or Spanish

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

18-64 year old men and women who are mothers or other infant caregivers of 2 week old infants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deepa R Camenga, MD	Yale University	Principal Investigator
Marjorie Rosenthal, MD MPH	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of St. Raphael		New Haven	Connecticut	06511	United States

Condition Browse Module

MeSH Terms

ID	Term
D014917	Whooping Cough

Ancestor Terms

ID	Term
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided