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Tdap Vaccination for Infant Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01233401
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : July 28, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Pertussis Vaccination Other: Survey

Study Design

Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Tdap Vaccination for Infant Caregivers in the Pediatric Office
Study Start Date : June 2010
Primary Completion Date : December 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Mothers Other: Survey
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.
Other Infant Caregivers
Includes fathers, grandparents, and other adults who are infant caregivers
Other: Survey
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.


Outcome Measures

Primary Outcome Measures :
  1. Maternal Tdap Vaccination Rate [ Time Frame: At 2 week well child visit ]

Secondary Outcome Measures :
  1. Other Infant Caregiver Tdap Vaccination Rate [ Time Frame: At 2 week well child visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
18-64 year old men and women who are mothers or other infant caregivers of 2 week old infants
Criteria

Inclusion Criteria:

  • 18-64 years old
  • English or Spanish speaking

Exclusion Criteria:

  • Do not speak English or Spanish
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233401


Locations
United States, Connecticut
Hospital of St. Raphael
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Saint Raphael Healthcare System
Investigators
Principal Investigator: Deepa R Camenga, MD Yale University
Principal Investigator: Marjorie Rosenthal, MD MPH Yale University
More Information

Responsible Party: Deepa Camenga, MD, Yale University
ClinicalTrials.gov Identifier: NCT01233401     History of Changes
Other Study ID Numbers: 1005006837
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

Keywords provided by Yale University:
Pertussis, Vaccination, Adult

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs