Education + Vaccination for Tdap Acceptance During Pregnancy
(ITAPP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Women and Infants Hospital of Rhode Island
Disqualifiers: Latex allergy, Lethal fetal anomaly
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this randomized control trial is to assess if prenatal vaccine education and in-office vaccination administration for non-birthing partners of pregnant patients increases Tdap vaccination rates compared to usual care.
The main question\[s\] it aims to answer are:
* To assess whether compared to standard prenatal care, targeted prenatal education regarding Tdap vaccination recommendations with and without in office vaccination opportunities improves Tdap uptake among non-birthing partners of pregnant patients.
* To assess whether non-birthing partners presenting for Tdap vaccination are willing to accept dual vaccination with Tdap and influenza.
Participants will receive direct verbal and written education at the time of enrollment on cocooning and recommendation for partner Tdap vaccination prior to delivery with or without the option to receive Tdap at their convenience at the WIH obstetric care clinic.
If there is a comparison group: Researchers will compare "Upfront Education" and "Upfront Education and Vaccination Administration" to "Usual care" to see if education and/or the offer for vaccination in the office increases Tdap vaccine acceptance for non-birthing partners.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on vaccination education and administration, so it's unlikely that your current medications will be affected.
What data supports the effectiveness of the Tdap vaccine during pregnancy?
Research shows that the Tdap vaccine given during pregnancy is effective at preventing pertussis (whooping cough) in infants less than 2 months old, which helps protect newborns from this serious infection.
12345Is the Tdap vaccine safe for use during pregnancy?
The Tdap vaccine is generally safe for use during pregnancy. Studies have shown that it is well tolerated by pregnant women and does not lead to pregnancy, postpartum, or neonatal complications. Common side effects are mild, such as pain at the injection site, and no unexpected adverse events have been reported.
678910How is the Tdap vaccine unique for pregnant women?
The Tdap vaccine is unique for pregnant women because it is specifically recommended during each pregnancy to protect newborns from pertussis (whooping cough), which is a serious illness for infants. This approach is different from other vaccines as it focuses on providing immunity to the baby through the mother before birth.
211121314Eligibility Criteria
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.Inclusion Criteria
I haven't had or am unsure if I've had the Tdap vaccine in the last 10 years.
Partners of pregnant patients who are receiving their prenatal care at the OGCC
I can speak and understand either English or Spanish.
+1 more
Exclusion Criteria
I am allergic to latex and cannot receive the state's Tdap vaccine.
Lethal fetal anomaly diagnosed prior to enrollment to prevent undue distress with follow-up postpartum
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Education and Enrollment
Direct verbal and written education on cocooning and recommendation for partner Tdap vaccination prior to delivery
During pregnancy
1 visit (in-person)
Vaccination Administration
Participants receive the option to receive Tdap vaccination at their convenience at the WIH obstetric care clinic
During pregnancy
Follow-up
Participants are monitored for Tdap and dual vaccination rates during pregnancy through 1 week postpartum
1 week postpartum
Participant Groups
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.
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
Tdap Vaccine is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Tdap Vaccine for:
- Pertussis prevention in newborns
- Tetanus prevention
- Diphtheria prevention
🇨🇦 Approved in Canada as Tdap Vaccine for:
- Pertussis prevention in newborns
- Tetanus prevention
- Diphtheria prevention
🇪🇺 Approved in European Union as Tdap Vaccine for:
- Pertussis prevention in newborns
- Tetanus prevention
- Diphtheria prevention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Women and Infants HospitalProvidence, RI
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Who Is Running the Clinical Trial?
Women and Infants Hospital of Rhode IslandLead Sponsor
References
Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine. [2022]GSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix 28 days before estimated conception or during pregnancy.
Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis. [2023]To evaluate the effectiveness of the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine containing five pertussis components (Tdap5; Adacel®, Sanofi) when given during pregnancy at preventing pertussis in infants less than 2 months of age.
Maternal and infant outcomes among women vaccinated against pertussis during pregnancy. [2018]Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination is recommended for all women during each pregnancy to prevent pertussis in young infants. However, data on the safety of this protective measure are limited and conflicting. To assess maternal and infant outcomes associated with administration of this vaccine during pregnancy, we reviewed medical records of 1,759 women who delivered a singleton infant at a southeast Texas public hospital between November 1, 2012 and June 30, 2014. After excluding women who had inadequate prenatal care or who delivered at
Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies. [2023]This observational retrospective matched cohort study evaluated the safety of a prenatal tetanus, diphtheria, acellular pertussis (Tdap) vaccination, Boostrix. We previously reported on the risk of maternal and neonatal outcomes; here we report on the risk of congenital anomalies in infants at birth through 6 months of age.
Trends and characteristics of Tdap vaccination during pregnancy in Ontario, Canada: a retrospective cohort study. [2023]In February 2018, Canada's National Advisory Committee on Immunization (NACI) recommended tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccination during pregnancy to protect newborns against pertussis infection. We sought to describe pre- and postrecommendation trends in Tdap vaccination coverage among pregnant Ontario residents.
Safety and use of tetanus-diphtheria-acellular pertussis-5 (Tdap5) vaccine during pregnancy: findings from 11 years of reporting to a pregnancy registry. [2022]The "Adacel (Tdap5) Pregnancy Registry" was used to identify 1182 women who received the tetanus, diphtheria, acellular pertussis [5 components] (Tdap5) vaccine during pregnancy from 2005 to 2016. To evaluate the safety and use of prenatal Tdap5, we calculated the rate of maternal, obstetrical, pregnancy and neonatal outcomes following Tdap5 pregnancy exposure and assessed vaccine uptake by year and trimester of exposure. The most commonly reported maternal adverse events included injection site reactions (2.6%; 95% Confidence Interval 1.8%, 3.7%), nervous system events (1.3%; 0.8%, 2.1%) and musculoskeletal events (1.1%; 0.6%, 1.9%). The most commonly reported complications of pregnancy were hypertension/preeclampsia (5.5%; 3.3%, 8.9%) and gestational diabetes (2.5%; 1.1%, 5.3%), while those for labor and delivery were premature labor (2.9%; 1.4%, 5.7%) and premature membrane rupture (1.5%; 0.4%, 3.8%). These rates were similar to, or lower than those reported for the general population of pregnant women. Among pregnancies with known birth outcomes (N = 275), 90.4% (86.2%, 93.4%) resulted in a live birth, 5.9% (3.6%, 9.5%) in spontaneous abortion, 3.0% (1.4%, 5.8%) in stillbirth, and 0.7% (0.0%, 2.8%) in ectopic pregnancies. Most newborns had normal APGAR scores and birth weights (98.1% and 93.0%, respectively), and only two reported a congenital anomaly (0.7%; 0.0%, 2.8%). An influx of reports in 2012 with third trimester Tdap5 exposure coincided with the 2012 updated Advisory Committee on Immunization Practices recommendations. This analysis did not identify any safety concerns across the continuum of maternal, obstetrical, pregnancy, and neonatal outcomes in women who received Tdap5 vaccination during pregnancy.
Infant outcomes after exposure to Tdap vaccine in pregnancy: an observational study. [2018]Pertussis vaccination during pregnancy has recently been recommended in both the USA and UK to prevent pertussis infection in infants. While there are no apparent safety concerns about the administration of Tdap vaccine during pregnancy, there is only limited safety data available. We aimed to closely monitor infants exposed to Tdap during pregnancy to look for any adverse outcomes that may be attributable to the vaccine.
Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women. [2022]We sought to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women who received tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap).
Safety and Clinical Benefits of Adacel® and Adacel®-Polio Vaccination in Pregnancy: A Structured Literature Review. [2023]Vaccination in pregnancy using a tetanus toxoid, reduced dose diphtheria toxoid, and reduced dose acellular pertussis (Tdap) vaccine is important for prevention of severe pertussis disease in young infants. The objectives of this systematic literature review were to search for original research studies evaluating the vaccine effectiveness, immunogenicity, and safety of Adacel®/Adacel-Polio® used during pregnancy to prevent pertussis disease in young infants. Medical databases used included EMBASE, BIOSIS Previews, and Chemical Abstracts, with search terms related to pregnancy, vaccines/immunization, safety, pertussis, effectiveness/efficacy, and immune response; other potentially eligible reports were included where applicable. Search results were restricted to literature published from 1 January 1995 to 26 July 2021. A total of 2021 articles and 4 other reports were identified for primary review. A total of 49 publications qualified for inclusion after primary and secondary reviews. Effectiveness studies of Adacel or Adacel-Polio given in pregnancy consistently showed high levels of protection from pertussis disease in the newborn (vaccine effectiveness: 91-93%). In immunogenicity studies, the response in pregnant women was consistent with that of non-pregnant women. Infants of mothers vaccinated with Adacel or Adacel-Polio in pregnancy had higher anti-pertussis antibody levels at birth and at 2 months of age compared to infants born to women vaccinated with comparator vaccines, placebo, or those not vaccinated during pregnancy. There was evidence of a slightly decreased response to primary pertussis vaccination in infants of mothers vaccinated with Adacel or Adacel-Polio, but this was not thought to be clinically significant. In safety studies, Adacel or Adacel-Polio vaccination was well tolerated by pregnant woman and not associated with pregnancy, postpartum, or neonatal complications. In conclusion, Adacel or Adacel-Polio vaccination in pregnancy is highly effective in protecting young infants from pertussis disease, with a favorable safety profile for both pregnant women and their infants.
Adverse event occurrence following use of tetanus, diphtheria and acellular pertussis adsorbed vaccine - Tdap -, São Paulo, SP, Brazil, 2015-2016. [2021]Objective to describe occurrence of adverse events following immunization (AEFI) with Tdap vaccine during pregnancy. Methods this was a descriptive study using data from reports by participants in an effectiveness and immunogenicity study conducted in two hospitals in São Paulo, SP, Brazil, from 2015 to 2016. Results of the 201 mothers included in the study, 48 (23.9%) had at least one AEFI; 60 symptoms related to Tdap use were identified - pain (22.4%), swelling (2.5%), fever (1.5%), somnolence (1.0%), redness (0.5%), vomiting (0.5%), headache (0.5%), local reaction (0.5%), and fatigue (0.5%); no rare, very rare, or extremely rare adverse events were reported; all events were considered to be expected, as they are described in the vaccine package insert; outcome of all events was recovery without sequelae. Conclusion Tdap vaccine in the form adopted by the National Immunization Program is safe; no unexpected adverse events were identified among vaccinated pregnant women.
Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations. [2022]The Advisory Committee on Immunization Practices (ACIP) recommends the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for pregnant women during each pregnancy, regardless of prior immunization status. However, safety data on repeated Tdap vaccination in pregnancy is lacking.
Pertussis Immunisation in Pregnancy Safety (PIPS) Study: A retrospective cohort study of safety outcomes in pregnant women vaccinated with Tdap vaccine. [2019]New Zealand has funded the administration of tetanus, diphtheria and acellular pertussis (Tdap) vaccine during pregnancy to prevent infant pertussis since 2013. The aim of this study was to assess the safety of Tdap vaccine administered to pregnant women as part of a national maternal immunisation programme.
Prevention of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants recommendations of the Advisory Committee on Immunization Practices (ACIP). [2022]In 2005, two tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines were licensed and recommended for use in adults and adolescents in the United States: ADACEL (sanofi pasteur, Swiftwater, Pennsylvania), which is licensed for use in persons aged 11--64 years, and BOOSTRIX (GlaxoSmithKline Biologicals, Rixensart, Belgium), which is licensed for use in persons aged 10-18 years. Both Tdap vaccines are licensed for single-dose use to add protection against pertussis and to replace the next dose of tetanus and diphtheria toxoids vaccine (Td). Available evidence does not address the safety of Tdap for pregnant women, their fetuses, or pregnancy outcomes sufficiently. Available data also do not indicate whether Tdap-induced transplacental maternal antibodies provide early protection against pertussis to infants or interfere with an infant's immune responses to routinely administered pediatric vaccines. Until additional information is available, CDC's Advisory Committee on Immunization Practices recommends that pregnant women who were not vaccinated previously with Tdap: 1) receive Tdap in the immediate postpartum period before discharge from hospital or birthing center, 2) may receive Tdap at an interval as short as 2 years since the most recent Td vaccine, 3) receive Td during pregnancy for tetanus and diphtheria protection when indicated, or 4) defer the Td vaccine indicated during pregnancy to substitute Tdap vaccine in the immediate postpartum period if the woman is likely to have sufficient protection against tetanus and diphtheria. Although pregnancy is not a contraindication for receiving Tdap vaccine, health-care providers should weigh the theoretical risks and benefits before choosing to administer Tdap vaccine to a pregnant woman. This report 1) describes the clinical features of pertussis, tetanus, and diphtheria among pregnant and postpartum women and their infants, 2) reviews available evidence of pertussis vaccination during pregnancy as a strategy to prevent infant pertussis, 3) summarizes Tdap vaccination policy in the United States, and 4) presents recommendations for use of Td and Tdap vaccines among pregnant and postpartum women.
Tetanus and diphtheria toxoids and acellular pertussis vaccine uptake during pregnancy in a metropolitan tertiary care center. [2018]Tetanus, diphtheria and acellular pertussis (Tdap) vaccine is recommended during each pregnancy, but national uptake is poor. We assessed Tdap uptake in a tertiary referral hospital served by university-affiliated and private obstetrical offices.