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Vaccine

Education + Vaccination for Tdap Acceptance During Pregnancy (ITAPP Trial)

Phase 4

Recruiting

Led By Laurie Griffin, MD/PhD

Research Sponsored by Women and Infants Hospital of Rhode Island

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 19-50 years old

Be between 18 and 65 years old

Must not have

Latex allergy: Contraindication to the state supplied Tdap vaccine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during pregnancy though 1 week postpartum

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to see if providing education on vaccines and offering vaccination for non-birthing partners of pregnant patients can increase Tdap vaccination rates. Participants will be given information about Tdap vaccination and may

Who is the study for?

This trial is for non-birthing partners of pregnant patients aged 19-50, receiving prenatal care at OGCC. They must not have had the adult Tdap vaccine or booster in the last 10 years or be unsure if they did. Participants need to understand English or Spanish.

What is being tested?

The study tests whether providing education on Tdap vaccination and offering vaccines directly at an obstetric clinic increases uptake among non-birthing partners compared to standard care. It also explores willingness to receive dual Tdap and influenza vaccinations.

What are the potential side effects?

While this trial focuses on education and vaccine administration, typical side effects of the Tdap vaccine may include pain at injection site, mild fever, fatigue, headache, nausea, and less commonly more serious reactions like allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 19 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to latex and cannot receive the state's Tdap vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during pregnancy though 1 week postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during pregnancy though 1 week postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and during pregnancy though 1 week postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tdap vaccination rate for non-birthing partners

Secondary study objectives

Dual vaccination rates for non-birthing partners

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Upfront Education and Vaccination Administration:Experimental Treatment2 Interventions

Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery plus the option to receive Tdap at their convenience at the WIH obstetric care clinic.

Group II: Upfront Education OnlyExperimental Treatment1 Intervention

Direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery

Group III: Usual CareActive Control1 Intervention

No up-front education, routine counseling as per their primary provider's standard practice, and written education on cocooning and recommendation for partner Tdap vaccination provided upon completion of the postpartum survey

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Education

2017

N/A

~4790

0 / 2Eligibility criteria met