Clinical trials: Whooping Cough
Pertussis
Establishing a Controlled Human Infection Model of Bordetella Pertussis
This study aims to establish a Controlled Human Infection Model of Bordetella pertussis by determining a reproducible and safe infectious bacterial dose (challenge inoculum) that achieves colonization and mild symptomatic…
- Trial name
- NCT05136599
- Testing
- Bordetella pertussis D420
- Where
- Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Dalhousie University
Pertussis, Whooping Cough
Study of BPZE1 (High Dose) Nasal Live Attenuated B. Pertussis Vaccine
This study evaluates the safety and immunogenicity of a higher dose formulation of a new live attenuated vaccine, BPZE1, intended to prevent Bordetella pertussis nasopharyngeal colonization and pertussis disease, and investigates…
- Trial name
- NCT02453048
- Testing
- BPZE1
- Where
- Sweden
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Diphtheria, Tetanus
Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents
This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents. The purposes of this study are as follows: To confirm the non-inferiority of BK1301 to Adsorbed…
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT02118961
- Testing
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301), Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)
- Where
- 7 sites in Japan
- Volunteers
- 446 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Tetanus, Diphtheria
Confirmatory Study of BK1310 in Healthy Infants
The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with…
- Conditions
- Tetanus, Diphtheria, Pertussis, Poliomyelitis
- Trial name
- NCT03891758
- Testing
- DPT-IPV-Hib, Hib vaccine, DPT-IPV
- Where
- Japan
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Bordetella Pertussis, Whooping Cough
Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children
This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both…
- Trial name
- NCT05116241
- Testing
- BPZE1 pertussis vaccine and Boostrix
- Where
- 16 sites in Australia, Costa Rica and 1 more
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- ILiAD Biotechnologies
Pregnancy
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
This is a pilot, prospective, randomized, open-label clinical trial. During the study, pregnant women will be randomized (1:1) to receive co-administration of a single intramuscular (IM) 0.5 mL dose of US-licensed inactivated…
- Trial name
- Tdap/IIV (NCT02783170)
- Testing
- Tetanus, Diphtheria, and Pertussis Vaccine, 2016-2017 Quadrivalent Inactivated Influenza Vaccine, 2017-2018 Quadrivalent Inactivated Influenza Vaccine
- Where
- 3 sites in United States
- Volunteers
- 81 people
- Sponsor
- Duke University
Clostridium Difficile Immunisation, Diphtheria
Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants
This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety, immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria acellular pertussis vaccine (Tdap) in…
- Conditions
- Clostridium Difficile Immunisation, Diphtheria, Diphtheria Immunisation, Pertussis
- Trial name
- NCT03589768
- Testing
- Tetanus and Diphtheria Toxoids Adsorbed, Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide
- Where
- 2 sites in United States, Mali
- Volunteers
- 399 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pertussis/Whooping Cough, Bordetella Pertussis, Whooping Cough
Pertussis Challenge Study in Adults Vaccinated With BPZE1
This is a randomised, double-blinded, placebo-controlled trial of BPZE1 that includes virulent B. pertussis challenge followed by a safety follow-up.
- Trial name
- CHAMPION-1 (NCT05461131)
- Testing
- BPZE1, Azithromycin, Bordetella Pertussis Challenge Strain
- Where
- 2 sites in United Kingdom
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- ILiAD Biotechnologies
Immunization; Infection, Pregnancy Related
Increasing Influenza and Tdap Vaccination of Pregnant Women
Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth.
- Trial name
- NCT04444518
- Testing
- VAX-MOM Intervention, Standard of Care
- Where
- United States
- Volunteers
- 12,760 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Pertussis, Pertussis Immunisation
Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults
This is a randomized, partially blind, placebo controlled, clinical trial evaluating a single intranasal dose of BPZE1 in healthy adults.
- Trial name
- NCT03541499
- Testing
- BPZE1
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pertussis, Whooping Cough
Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults
This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose…
- Trial name
- NCT03942406
- Testing
- BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ILiAD Biotechnologies
Whooping Cough
The Safety of Boostrix Following Routine Immunization of Pregnant Women
The purpose of this study was to assess the safety of Boostrix administered on or after the first day of the 27th week of pregnancy by conducting a post-marketing study that provided safety information to the public and…
- Trial name
- NCT03463577
- Testing
- Safety assessment following routine immunization with Boostrix
- Where
- United States
- Volunteers
- 65,783 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Post Marketing Surveillance for ADACEL™ in South Korea
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT01137435
- Testing
- ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
- Where
- 2 sites in South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Tetanus, Diphtheria
Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine.
- Conditions
- Tetanus, Diphtheria, Pertussis, Whooping Cough
- Trial name
- NCT01439165
- Testing
- Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine, Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
- Where
- 33 sites in United States, Canada
- Volunteers
- 1,330 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT01437423
- Testing
- TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Tetanus, Diphtheria
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US).
- Conditions
- Tetanus, Diphtheria, Pertussis, Whooping Cough
- Trial name
- NCT02587520
- Testing
- Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
- Where
- 20 sites in United States
- Volunteers
- 1,363 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pertussis
Boostrix® Pregnancy Registry
The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies in the US.
- Trial name
- NCT02096276
- Testing
- Data collection
- Where
- United States
- Volunteers
- 1,517 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria-Tetanus-acellular Pertussis Vaccines
Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects
Diphtheria, tetanus and pertussis are common causes of diseases worldwide, with significant morbidity and mortality. The purpose of this study is to assess the immunogenicity, safety and reactogenicity of a single dose of…
- Trial name
- NCT03311659
- Testing
- Boostrix
- Where
- 8 sites in Russia
- Volunteers
- 448 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Whooping Cough
Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States
The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.
- Trial name
- NCT03973905
- Testing
- Not applicable / dataset analysis
- Where
- Belgium
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Pertussis
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)
This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old…
- Trial name
- NCT02759354
- Testing
- Blood Sample
- Volunteers
- 754 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.