TDAP Safety in Pregnant Women

Learn more about:
Related Clinical Trial
Pertussis Acellular Vaccine Adjuvanted With TQL1055 Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan A Multi-center Study to Determine the Prevalence and Influence of Pertussis on Subacute Cough in Shenzhen A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen Assessment, Feedback, Incentive, Exchange (AFIX OB) A Customizable Quality Improvement Intervention to Increase Maternal Vaccine Uptake To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years Maternal Pertussis Wholecell Responses Adacel® Booster Vaccination for CMI Assay Development Pathogenic Bordetella Rapid Detection 5-year Follow-up After a Single Dose Acellular Pertussis Vaccination Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda Mobile Phone SMS Messages and Automated Calls in Improving Vaccine Coverage Among Children in Pakistan Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly CD8 Reactivity to Microorganisms in Blood and Breast Milk Testing the Use of Prompts to Increase Adolescent Immunization Rates Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age Pilot Study Freeze and Transport Immune Cells Increasing Vaccine Uptake Among Veterans at the Atlanta VA Health Care System Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants Immunogenicity and Safety of Sanofi Pasteur’s Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months. DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants Retrospective Survey of Safety of Fourth Dose Pentacel® in Children Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China Pentavalent DTaP-Hep B-IPV DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants Evaluation of an Infant Immunization Encouragement Program in Nigeria A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™ Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™ How Does the Clinical Tool ‘What’s Going Around’ Affect Clinical Practice Pneumococcal Vaccine and Routine Pediatric Immunizations in HIV-Infected Children Receiving Anti-HIV Drugs Immunology of Non-specific Effects of Vaccine Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar® Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth Immunogenicity and Safety of Pentaxim in South African Infants Immunogenicity and Safety of Pentaxim™ in an Indian Population Boostrix® Pregnancy Registry Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants Montelukast for Persistent Cough in Young People and Adults Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035) Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL® Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™ Database Surveillance Safety Study of PENTACEL® Vaccine A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject A Study to Assess the Immunogenicity and Safety of GSK Biologicals’ Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting Protecting Pregnant Women From Infectious Diseases A Study to Assess the Safety of Adacel® Vaccine Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV Immunogenicity and Safety of Adacel Polio Vaccine Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL® Confirmatory Study of BK1310 in Healthy Infants Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED) Influence of BCG on TDaP-IPV Vaccination A Phase IV Study to Assess the Safety of EupentaTM Inj Phase I Clinical Trial in Healthy Children The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025) Maternal Antibody in Milk After Vaccination Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age Safety and Immune Response of Different Pediatric Combination Vaccines. Sanofi Pasteur’s Tdap Combined Vaccine as a Booster Versus Local DT Vaccine in Children or Versus Local Td Vaccine in Adolescents and Adults in China. Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED) Tdap Vaccination for Infant Caregivers Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX® TDAP Safety in Pregnant Women Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine The Safety of Boostrix Following Routine Immunization of Pregnant Women Regulatory Post-Marketing Surveillance Study for TETRAXIM™ Tdap Vaccine in Post-Partum Women Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents Post Marketing Surveillance for ADACEL™ in South Korea Vouchers to Promote Tdap Vaccination Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS Descriptive, Open-label, Multicenter Study of the Safety of Redosing With ADACEL® Vaccine Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1) Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN) Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibodies Response After a Single Dose of Tdap Vaccine in Thai Pregnant Women Viaskin Pertussis Vaccine Trial Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine The Feasibility of Pertussis Immunization in a Canadian Emergency Department Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012) Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines Assessing Contacts’ Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines Maternal Tdap Immunization in Guatemala Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 – 12 Years Old The PertADO Geneva Trial Study of Adacel® Vaccine Administered to Persons 10 Years of Age Pertussis Immunization During Pregnancy & HIV Infection Observational Study Describing the Immune Profile Induced By Pertussis Vaccines Sero-prevalence of Anti-pertussis Antibodies and Disease Awareness Among Spanish Healthcare Professionals Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Pertussis and Meningitis C Concomitant Vaccination in Adolescents Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine 2-year Follow-up After a Single Dose Acellular Pertussis Vaccination Pertussis Vaccine in Healthy Pregnant Women Pertussis Vaccination in Pregnant Women A Study Exploring Whooping Cough Protection in Children and Adults Immunising Mums Against Pertussis 3 3-year Follow-up After a Single Dose Acellular Pertussis Vaccination A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine Optimising the Timing of Whooping Cough Immunisation in MUMs Bordetella Pertussis Colonisation Challenge Study Vaccine Responses in Infants After Acellular Pertussis Vaccination During Pregnancy in Thailand Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines Gambia Pertussis Study (GaPs) A Phase 1/2 Clinical Trial of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults Vanderbilt Pertussis Exposure Study: PEP in Vaccinated Healthcare Workers Following Pertussis Exposure A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy 3 to 5 Months Infants Pertussis Infection in Adolescents and Adults With Prolonged Cough Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants Pertussis (Tdap) Vaccination in Pregnancy

Brief Title

TDAP Safety in Pregnant Women

Official Title

Clinical Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) Safety in Pregnant Women

Brief Summary

      The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced
      Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0
      days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be
      verified by medical record review when possible. There will be an emphasis on enrolling women
      who have received Tdap before the current pregnancy, to the greatest extent possible.
      Non-pregnant women who are receiving their initial Tdap will also be recruited.

      Injection-site (local) and systemic reaction data will be assessed on the vaccination day and
      during the 7 days following vaccination using either identical web-based or paper diaries,
      depending on the preference of the study participant.

      Pregnant women will be followed until delivery with comprehensive obstetric and neonatal
      outcomes obtained from review of the electronic medical record.
    

Detailed Description

      This is an observational study of both pregnant and non-pregnant women. Vaccine
      administration in the pregnant population will be part of routine care. Vaccine
      administration in the non-pregnant women will be provided as either routine care or as part
      of the study. Pregnant women at ≥ 20 weeks 0 days gestation who have not received Tdap during
      the current pregnancy will be enrolled, with prioritized emphasis on enrolling pregnant women
      who have received Tdap prior to the current pregnancy in order to attempt to address the
      question of closely-spaced repeated dosing. Detailed data will be collected from study
      participants on prior Tdap/Td/TT receipt. The non-pregnant women will consist of both Tdap
      naïve and those who have received Tdap previously. With Day 0 serving as the day of
      vaccination, participants will be followed through Day 7 for symptoms of reactogenicity. For
      Primary Objective 1, symptoms of reactogenicity occurring from Day 0 -7 will be compared
      between pregnant and non-pregnant women. For Objective 2, pregnant women will be followed
      through delivery for collection of pregnancy outcome data. Pregnancy outcomes among study
      participants will be compared with historical outcomes from summary data from both Vanderbilt
      and Duke. In addition, follow-up will be conducted for infants born to mothers who received
      Tdap during pregnancy to assess health outcomes and growth parameters through 6 months of
      life.
    


Study Type

Observational


Primary Outcome

Rates of injection-site and systemic reactions post Tdap administration.

Secondary Outcome

 Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose

Condition

Pertussis

Intervention

TDAP

Study Arms / Comparison Groups

 Pregnant Women receiving TDAP
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

375

Start Date

May 2014

Completion Date

December 18, 2017

Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion:

        Subjects who meet the following criteria will be eligible to participate in this
        observational study. Tdap administration will be given as routine standard of care.

          -  Pregnant and non-pregnant women, as determined by medical history, aged 18 - 45 years
             of age inclusive

          -  For pregnant women only - Singleton gestation ≥ 20 weeks 0 days gestation - ≤34 weeks
             0 days gestation based on reconciliation of last menstrual period and ultrasound
             dating. Estimated due date (EDD) and Gestational Age (GA) - EDD will be based on
             reconciliation of a "sure" first day of the last menstrual period (LMP) and earliest
             dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will
             be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with
             sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the
             ultrasound derived EDD is not in agreement with the LMP-derived EDD, the
             ultrasound-derived EDD is used to determine GA.

          -  Intention of receiving Tdap vaccine based on ACIP guidelines

          -  Willing to provide written informed consent prior to initiation of any study
             procedures

          -  English or Spanish literate

          -  Intention of being available for entire study period and complete all relevant study
             procedures

        Exclusion:

          -  Subjects who meet the following criteria will not be eligible to participate in this
             study:

          -  Febrile illness within the last 24 hours or an oral temperature > 100.4oF (> 38oC)
             prior to Tdap administration

          -  Severe allergic reaction (e.g., anaphylaxis) to any component of Tdap or any other
             diphtheria toxoid, tetanus toxoid and pertussis antigen containing vaccine

          -  Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures)
             within 7 days of administration of a previous pertussis antigen-containing vaccine.

          -  Known or suspected impairment of immunologic function including active infection with
             HIV, hepatitis B or C, current use of glucocorticoids, i.e., oral, parenteral, and
             high-dose inhaled steroids, and immunosuppressive or cytotoxic drugs.

          -  Note, if a woman were to require antenatal corticosteroids for benefit of fetal lung
             maturity within 8 days post enrollment, she would not be excluded from the study for
             reactogenicity analysis. However, if antenatal corticosteroids were received anytime
             between vaccination and 28-day sample collection for serologic studies, she would be
             excluded from serologic studies as they could be altered by steroid receipt.

          -  Receipt of any licensed vaccine OR investigational product within 1 week prior to Tdap
             vaccination in this study or planning receipt of any vaccines during 8-day
             post-vaccination period.

          -  Note, any woman receiving an investigational vaccine or live vaccine inadvertently at
             any time during pregnancy will be excluded from analysis. (Note, inadvertent receipt
             of licensed HPV vaccine or any other inactivated licensed vaccine outside of the
             parameters specified above is not a reason for exclusion).

          -  Any condition which, in the opinion of the investigators, may pose a health risk to
             the subject or interfere with the evaluation of the study objectives.

          -  Anyone who is a relative of any research study personnel

          -  Anyone who is an employee of any research study personnel

          -  For pregnant women only

          -  Tdap/Td/TT receipt during current pregnancy prior to study enrollment

          -  Signs or symptoms of active preterm labor, defined as regular uterine contractions
             with cervical change

          -  For non-pregnant women only

          -  Intention of becoming pregnant during study participation

          -  Anyone who is already enrolled or plans to enroll in another clinical trial with an
             investigational product within 30 days of Tdap receipt. Co-enrollment in observational
             or behavioral intervention studies are allowed at any time while enrollment in a
             clinical trial involving an investigational product (other than vaccine) may occur
             after 30 days following Tdap receipt. Receipt of inactivated vaccines during
             pregnancy, including routinely recommended inactivated influenza vaccine, given as
             part of usual care, is not an exclusion for this study, except during the 8 days after
             Tdap vaccination
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kathryn M Edwards, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02209623

Organization ID

CISA 2014 Task III


Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt University

Collaborators

 Duke University

Study Sponsor

Kathryn M Edwards, MD, Principal Investigator, Vanderbilt Medical Center


Verification Date

December 2017