PertussisNCT01233401
Tdap Vaccination for Infant Caregivers
An observational study of Pertussis and Vaccination, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Vaccination
- What is being tested?
- Survey
- Type of treatment
- Vaccines
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 18-64 year old men and women who are mothers or other infant caregivers of 2 week old infants
Who may be able to join
- 18-64 years old
- English or Spanish speaking
Who cannot join
- Do not speak English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of St. Raphael
New Haven, Connecticut, 06511
About this study
Official title: Tdap Vaccination for Infant Caregivers in the Pediatric Office
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.
- Conditions
- Pertussis, Vaccination
- Being tested
- Survey
- Keywords
- Pertussis, Vaccination, Adult
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mothers | Not described Receives: Other: Survey | |
| Other Infant Caregivers | Includes fathers, grandparents, and other adults who are infant caregivers Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Tdap Vaccination Rate
Measured: At 2 week well child visit
Secondary outcomes (1)
Other Infant Caregiver Tdap Vaccination Rate
Measured: At 2 week well child visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Raphael Healthcare System
- Investigators
- Deepa R Camenga, MD, Principal investigator, Yale UniversityMarjorie Rosenthal, MD MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233401
- Sponsor's protocol ID
- 1005006837
- Status last verified
- Jul 2011
- First submitted
- 1 Nov 2010
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tdap Vaccination for Infant Caregivers in the Pediatric Office
- ClinicalTrials.gov ID
- NCT01233401
- Acronym / sponsor ID
- 1005006837
- Conditions
- Pertussis, Vaccination
- Keywords
- Pertussis, Vaccination, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Saint Raphael Healthcare System
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers | – | Other: Survey |
| Other Infant Caregivers | – | Other: SurveyIncludes fathers, grandparents, and other adults who are infant caregivers |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18-64 year old men and women who are mothers or other infant caregivers of 2 week old infants
Key inclusion criteria (2 listed)
- 18-64 years old
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Do not speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyMothers 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 | Mothers, Other Infant Caregivers |
Primary outcome
Maternal Tdap Vaccination Rate
Time frame: At 2 week well child visit
1 secondary outcome
Other Infant Caregiver Tdap Vaccination Rate
Time frame: At 2 week well child visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
Related trials for Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepa R Camenga, MD principal investigator
Yale University
Marjorie Rosenthal, MD MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis and Vaccination, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Tdap Vaccination Rate (time frame: At 2 week well child visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.