Clinical Trials for Whooping Cough

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Whooping Cough from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 12
• Active, not recruiting: 10
• Completed: 22
• Other: 6

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT05847322 — Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks

Primary objective- To assess the safety of nasal inoculation of healthy volunteers with B. pertussis with antibiotic therapy given to eradicate colonisation at 6 weeks after inoculation or at symptom onset, whichever occurs first

Secondary objectives - To measure the rate of natural clearance of carriage of B. pertussis following nasal inoculation

• To assess the kinetics of B. pertussis colo…

NCT06803524 — 10-year Follow-up After a Single Dose Acellular Pertussis Vaccination

This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet’s recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (…

NCT06947499 — A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants

NCT06997627 — A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults

This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.

NCT07112144 — Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

The immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months.

NCT07097012 — Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy

The goal of this clinical trial is to learn if the RSV vaccine (protects against respiratory syncytial virus) and Tdap vaccine (protects against pertussis) are most effective in pregnant individuals when taken together at the same visit, or separately at different visits. This clinical trial will also learn about the safety and immune responses of these vaccines in pregnancy.

The Main question…

NCT06827470 — Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetella Pertussis

The overall goal of this study is to establish a PRN-deficient pertussis Controlled Human Infection Model (CHIM) that represents currently circulating isolates, in the context of a North American exposure (vaccination and infection) pedigree.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective

RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.

RACSMEI will improve understanding across multiple pathogens using a multidisciplinary One He…

NCT07203755 — Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design. Part One is divided into four stages based on age and vaccine dose levels. Part Two consists of the 2-month-old vaccine/placebo groups.

NCT06815250 — Enhancing Maternal Vaccine Knowledge and Uptake: The InTroDuce-Programme Trial

The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women’s knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. The main questions it aims to answer are:

Does the InTroDuce-Programme increase knowledge and future intention of pregnant mothers to get vaccinat…

NCT07596199 — A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women

The purpose of this Phase 3, non-randomized, single-arm, open-label study is to evaluate the immune response, reactogenicity and safety of GSKs dTpa vaccine in Japanese pregnant women between 27 weeks and less than 37 weeks of pregnancy. Both the pregnant women and their neonates born during the study will be evaluated for specific analyses.

NCT07596173 — A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Healthy Japanese Adolescents Aged 11 Years to <13 Years

The purpose of the study is to assess the immune response, reactogenicity and safety of a booster dose of dTpa vaccine 1 month after vaccination in healthy Japanese participants aged 11 to <13 years.

Active, Not Recruiting

NCT05091619 — A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

The study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts:

PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) …

NCT05864118 — Comparison of Nasopharyngeal Swab v. Nasopharyngeal Saline Wash or Saliva Collection in Testing for Respiratory Viruses

Respiratory tract infections (RTIs) are prevalence community diseases and is the third leading cause of death worldwide. Rapid diagnosis of RTIs is essential as it drives decision points such as treatment, disposition, and containment. According to recent CDC (The Centers for Disease Control and Prevention) updates, nasopharyngeal swabbing is the preferred method of specimen collection for most…

NCT06056050 — A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)

Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. Currently, there is no clinical trial registration of Diphtheria, tetanus, and pertussis (DPT) vaccine applicable to ≥6 y…

NCT06258057 — Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy

The purpose of this study is to evaluate the safety of Adacel vaccine among pregnant individuals exposed to Adacel at any point between the 1st day of the 27th week of gestation up to the end of pregnancy and their offspring (ie, Adacel-exposed cohort), in comparison with pregnant individuals not vaccinated with any Tdap vaccines during pregnancy and their offspring (ie, Tdap-unvaccinated compa…

NCT06640387 — CARE-ID: Dynamics of Respiratory Infections in Children and Transmission in Households and Schools

Viral respiratory tract infections are very common in children. They contribute to missed time in school, work disruption for caregivers and can also cause severe illness requiring hospitalization and rarely death. In the 2022-2023, influenza, RSV and SARS-CoV-2 viruses infected a large number of children which strained the pediatric healthcare system in many jurisdictions. Unfortunately, there…

NCT06903221 — A Phase 4, Randomised Vaccination Study in Healthy Adults to Investigate the Effects of Acellular Pertussis Vaccine on Colonisation With Bordetella Pertussis Using Controlled Human Infection

The goal of this clinical trial is to investigate the effect of booster vaccination with acellular pertussis vaccine on colonization with Bordetella pertussis using a controlled human infection model in healthy volunteers. The main questions it aims to answer are:

• Whether booster vaccination with Tdap-IPV reduces Bp colonisation after intranasal challenge with the standard Bp inoculum dose c…

NCT06888076 — Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Pregnant Women

This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen®.

Following approval of the final protocol from the Institutional Review Board (IRB) and/or Ethics Committee (EC) and written approval from hospital directors/medical…

NCT06708286 — A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)

This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase I…

NCT06798831 — Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults

This pivotal safety trial aims to extend the safety database for BioNet recombinant acellular pertussis (aP) vaccine (Pertagen®) in a larger population of adults and evaluate the incidence and characteristics of adverse drug reactions (ADRs), including uncommon events, to provide robust safety data. The study focuses on identifying and describing all ADRs following vaccination with BioNet recom…

NCT06857370 — Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine

This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 months of age.

Not Yet Recruiting

NCT06920069 — Study of Concomitant Administration of the sIPV and DTaP or MMR

This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR in infants aged 2 months. Primary immunogenicity endpoints in all groups include the seroconversion rate of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 day…

NCT07418372 — Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine

This is a randomized, double-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.

NCT07492303 — A Phase I Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)

the safety and tolerability of different dosages of adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine

NCT07621341 — Maternal Immunization With Tetanus Toxoid, Reduced Diphtheria Toxoid, Reduced-dose (2 µg) Recombinant Pertussis Vaccine (TdaP2gen) and Its Effect on the Immune Response in Thai Infants up to 15-18 Months Old

Pertussis remains a major global public health problem. In Thailand, pertussis vaccination is recommended during pregnancy at 20-32 weeks’ gestation, together with routine childhood diphtheria-tetanus-pertussis vaccination administered as a primary series at 2, 4, and 6 months and booster doses at 18 months and 4-6 years of age.

TdaP2gen, a newly developed combined tetanus, diphtheria, and rec…

Enrolling by Invitation

NCT07005726 — BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine and Infant Mortality in Africa

Studies in low-income countries show that vaccines can have important non-specific effects on other infections. Live BCG vaccine can train the immune system and reduce susceptibility to unrelated infections. In contrast, non-live diphtheria-tetanus-pertussis-containing (DTP) vaccine enhances susceptibility in females: DTP vs no DTP is associated with 2-fold higher mortality, and in DTP-vaccinat…

Completed Trials

NCT01188512 — First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine

The purpose of this study is to evaluate the safety and immunogenicity of a new live attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating, placebo-controlled study on a genetically modified B. pertussis strain given as a single intranasal dose to healthy adult male volunteers.

Effective vaccines are needed to protect young infants (from 0 to 6 months, today…

NCT02118961 — 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 Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies
• To confirm t…

NCT02453048 — 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 whether higher doses of BPZE1 induce the live vaccine to colonize subjects’ nasopharynx. The study is a Phase Ib (high dose), single centre, dose-escalating, placebo-c…

NCT02783170 — 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 influenza vaccine (IIV) and a single intramuscular (IM) 0.5 mL dose of US-licensed Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap…

NCT02992925 — Phase 3 Study of BK1310 in Healthy Infants

The purpose of this study is to:

• (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
• (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.

NCT03188692 — Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants

The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.

NCT07444502 — Safety Monitoring of Boostagen® Vaccine in Thailand

This study is designed to monitor the safety of Boostagen® after it has been approved for use in Thailand. The study follows people who receive the vaccine in routine medical practice to identify and record any side effects.

Doctors, nurses, and other healthcare professionals from hospitals and clinics in central, eastern, southern, and northern Thailand take part in the study. They report any…

NCT03587610 — Evaluation of a Tdap-IPV (Tetanus, Diphteria, Pertussis and Inactivated Polio) Vaccination Remedial Strategy on Vaccination Coverage in Patients 65 Years of Age or Older

In France, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). These numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively.

The primary objective of this study is to evaluate the impact of a hospital based vaccina…

NCT07400120 — Safety Monitoring of VacPertagen Vaccine in Thailand

In compliance with Thailand’s conditional approval requirements, this prospective, observational study is designed to actively monitor the safety of VacPertagen vaccine. Healthcare professionals (HCPs) prescribing or administering the vaccine are recruited from hospitals and clinics across central, eastern, southern and northern Thailand. Adverse events following immunization (AEFIs) are report…

NCT03589768 — 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 pregnant women in Mali. 200 healthy pregnant women, ages 18 through 39 years, inclusive, who meet all eligibility criteria will be randomly allocated in a 2:1 ratio to rece…

NCT03891758 — 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 co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.

NCT04082299 — Immune Response followingTdap Vaccine in Pregnancy

Pregnancy involves changes in immune response. The investigators aim to evaluate the immune response to Tdap in pregnancy in comparison to non pregnant women usig proteomics and gene sequencing.

NCT04398706 — Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants

Primary objectives:

• To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection).
• To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4)
• To assess the immune response (serotype specific IgG concentrat…

NCT04429295 — Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand

Primary Objective:

To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV

Secondary Objective:

• To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV)
• To describe the immune response to co-a…

NCT07213089 — Immunogenicity of a Combined Diphtheria-Tetanus-recombinant Acellular Pertussis (DTaP) Vaccine in Healthy Toddlers

Recombinant acellular pertussis vaccines containing genetically detoxified Pertussis Toxin (PTgen) have been used for booster immunisation in children, adolescents and adults including pregnant women in Thailand. Three vaccines have been licensed in Thailand, a monovalent (aPgen) and two vaccines combined with tetanus and reduced diphtheria dose vaccines (TdaPgen and Tdapgen). To address the ne…

NCT04300192 — Study to Evaluate the Immune Response After Booster Vaccination With Tdap-IPV Vaccine (Against Tetanus, Diphtheria, Pertussis and Poliomyelitis) in Children Who Received Different Pertussis Primary Vaccine Regimens in Republic of South Africa

Primary Objectives :

• To describe the long-term humoral immune responses to pertussis, diphtheria, and tetanus after homologous and heterologous pertussis vaccine priming regimens
• To determine the effects of the priming regimen on humoral responses to booster vaccination with Tdap-IPV vaccine
• To describe the long-term cell-mediated immune responses to pertussis after homologous and hetero…

NCT05116241 — 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 BPZE1 and Boostrix vaccines. This is a multi-center, randomized, placebo- and active-comparator-controlled study in healthy, school-age children with a 6-month safety foll…

NCT05136599 — 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 infection in healthy adults.

NCT05264662 — Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women

Pertussis (also known as whooping cough) is a highly contagious, vaccine-preventable respiratory tract disease, caused by the bacteria Bordetella pertussis. It can affect people of all ages, however young unimmunised or partially immunised infants are the most vulnerable group with the highest rates of complications and death. Recent surveillance data and an increase in the number of pertussis …

NCT05662852 — Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors

The goal of this clinical trial is to investigate the safety and tetanus antibody response to a Tdap vaccine in healthy plasma donors. The main question it aims to answer are:

• Is it safe to give this vaccine multiple times over one year to plasma donors since the package insert for this vaccine indicates that it should administered once every 10 years?
• What is the tetanus antibody response…

NCT05856396 — Maternal Determinants of Infant Immunity to Pertussis

The overall objective of the project is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. Using maternal pertussis immunization as a model, the project will identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in inf…

NCT06413121 — Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV

In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent OPV that lacks the type 2 Sabin virus. Since the WHA resolution, all countries…

Other (Withdrawn)

NCT05482282 — Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).