NCT01233401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

6 months

First QC Date

November 1, 2010

Last Update Submit

July 26, 2011

Conditions

PertussisVaccination

Keywords

Pertussis, Vaccination, Adult

Outcome Measures

Primary Outcomes (1)

  • Maternal Tdap Vaccination Rate

    At 2 week well child visit

Secondary Outcomes (1)

  • Other Infant Caregiver Tdap Vaccination Rate

    At 2 week well child visit

Study Arms (2)

Mothers

Other: Survey

Other Infant Caregivers

Includes fathers, grandparents, and other adults who are infant caregivers

Other: Survey

Interventions

SurveyOTHER

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.

MothersOther Infant Caregivers

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years old
  • English or Spanish speaking

You may not qualify if:

  • Do not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of St. Raphael

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Whooping Cough

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Deepa R Camenga, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Marjorie Rosenthal, MD MPH

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 3, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

July 28, 2011

Record last verified: 2011-07

Locations

US(1)