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Whooping Cough clinical trials

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NCT ID: NCT06258057 Active, not recruiting - Clinical trials for Pertussis (Whooping Cough)

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

Start date: January 16, 2024
Phase:
Study type: Observational

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 comparator cohort). The primary objectives are to estimate incidence rates and relative risks for each prespecified pregnancy outcome in Adacel-exposed and Tdap-unvaccinated comparator cohorts and for each prespecified adverse birth outcome in the offspring of both cohorts. The secondary objectives are to estimate incidence rates and relative risks for each prespecified adverse fetal and neonatal outcome in the offspring of Adacel-exposed and Tdap unvaccinated comparator cohorts and for each prespecified adverse outcome for pregnant individuals in both cohorts.

NCT ID: NCT05951725 Active, not recruiting - Clinical trials for Diphtheria, Tetanus and Acellular Pertussis

A Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed(DTcP)

Start date: August 11, 2023
Phase: Phase 3
Study type: Interventional

The combined pertussis, diphtheria and tetanus vaccine, the first vaccine to be included in the Expanded Programme of Immunization(EPI) of World Health Organization(WHO), has played an important role in the prevention and control of these three infectious diseases. The (diphtheria,tetanus and acellular pertussis combined vaccine,DTaP) vaccine was successfully developed in China in 1993, and its safety and serological effects were confirmed by the observation of human safety, with mild vaccination reactions and good immunization effects.The (Diphtheria-tetanus-component acellular pertussis vaccine, DTcP) vaccine is suitable for immunization against pertussis, diphtheria and tetanus infections in people between 2 and 24 months of age.

NCT ID: NCT05264662 Active, not recruiting - dTap Vaccine Clinical Trials

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

Start date: March 8, 2022
Phase: Phase 4
Study type: Interventional

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 outbreaks being reported nationally, indicate an increase in the incidence of pertussis disease in South Africa.To date there is no data on the effect of vaccinating HIV-infected pregnant women with pertussis-containing vaccines, although there is no reason to think that vaccinating these women would be harmful for them or their foetus. The knowledge gaps on the immunogenicity, safety and VE of pertussis vaccination of HIV-infected pregnant women should be addressed. Adacel which is a registered and licensed vaccine manufactured by Sanofi Pasteur, will be tested in this study.

NCT ID: NCT05116241 Active, not recruiting - Clinical trials for Bordetella Pertussis, Whooping Cough

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children

Start date: October 28, 2021
Phase: Phase 2
Study type: Interventional

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 follow-up after the first vaccination.

NCT ID: NCT05091619 Active, not recruiting - Tetanus Clinical Trials

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

DTaP
Start date: October 22, 2021
Phase: Phase 3
Study type: Interventional

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) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM),compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence. PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.

NCT ID: NCT03908164 Active, not recruiting - Pregnancy Related Clinical Trials

Optimising the Timing of Whooping Cough Immunisation in MUMs

OpTIMUM
Start date: May 7, 2019
Phase: Phase 4
Study type: Interventional

A multicentre study to evaluate the impact of timing of whooping cough (pertussis) vaccination in pregnancy, with participants randomised to receive whooping cough vaccination at one of three time points in pregnancy.

NCT ID: NCT03606096 Active, not recruiting - Pertussis Clinical Trials

Gambia Pertussis Study (GaPs)

GaPs
Start date: January 23, 2019
Phase: Phase 4
Study type: Interventional

Currently, there are two types of vaccines available against pertussis (whooping cough), an infectious disease of the respiratory tract that can be extremely serious in very young children. Both have advantages and disadvantages: The acellular form (aP, mainly used in resource-rich countries) does not appear to offer as long lasting protection, but the whole cell vaccine (wP, mainly used in LMIC) appears to be generally more reactogenic. There is consensus that a "better pertussis vaccine" ought to be designed. The GaPs trial is part of a series of clinical trials performed by the PERtussIS COrrelates of Protection Europe (PERISCOPE) Consortium, an EU-funded group of investigators which aims to generate knowledge on immune responses to pertussis. A better understanding of human biomarkers of protective immune responses to B. pertussis and its waning immunity is needed to accelerate the design and testing of new pertussis vaccines with a longer duration of protection. This proposal describes the design and objectives of the clinical trial to be conducted in the Gambia, which is the only site in Africa involved in the consortium and involves the recruitment of 600 mother/infant pairs. Pregnant women will be randomised to receive either the usually recommended tetanus vaccination or a combination vaccine against whooping cough, diptheria, tetanus and polio. Their infants will receive either aP or wP as part of their EPI vaccines, and resulting immune responses will be characterized in detail up to the age of 9 months. The investigators will use immunological assays to investigate the functional humoral and cellular responses to pertussis in infants born to mothers who are randomized to receiving pertussis vaccine in pregnancy or not, and their infants who will receive either aP or wP vaccine. Our research questions are: Does vaccination against pertussis in pregnancy have impact on subsequent immune responses to pertussis vaccine and other EPI vaccines in the infants Does vaccination of infants with wP vaccine induce different levels and functionality of antibody and/or T cell responses than vaccination with aP vaccine What is the difference in innate and acquired immunity- as measured with novel systems vaccinology tools- between being vaccinated with wP versus aP?

NCT ID: NCT02813486 Active, not recruiting - Tetanus Clinical Trials

Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine

Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of age.

NCT ID: NCT02771782 Active, not recruiting - Whooping Cough Clinical Trials

Influence of BCG on TDaP-IPV Vaccination

Start date: January 2015
Phase: Phase 4
Study type: Interventional

This study has three purposes: To investigate whether the immune response to pertussis is increased when TDaP-IPV is given together with BCG vaccine, compared to when it is given alone. To investigate whether BCG vaccination modulates the immune response to non vaccine target antigens (i.e., antigens/pathogens not used in the vaccine itself). To investigate whether TDaP-IPV vaccination modulates the immune response to non vaccine target antigens.

NCT ID: NCT02511327 Active, not recruiting - Pertussis Clinical Trials

Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants

MAMA
Start date: January 2015
Phase:
Study type: Observational

Young infants are most vulnerable to severe disease and even death when infected with Bordetella Pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates. During the last weeks of pregnancy, maternal IgG antibodies are transferred actively to the fetus. Administration of a pertussis containing vaccine during pregnancy offers protection through high titers of maternal antibodies transferred to the child. Since transplacental transport is immature, infants who are born prior to 37 weeks of gestation, might be vulnerable to pertussis infection even though maternal vaccination was administered, but specific data are lacking. The primary aim of this observational study is to measure whether vaccination during pregnancy offers protection to preterm born infants through higher titers of maternal antibodies, despite immature transplacental transport. Four cohorts of mother-infant pairs will be recruited: term versus preterm born infants, born from either vaccinated women or not vaccinated women. These mother-infant pairs are recruited according to the vaccination status of the mother and to the gestational age at delivery. Pertussis specific antibody titers (anti-Pertussis Toxin, anti-Filamentous haemagglutinin, anti-Pertactin titers) will be monitored in blood samples of the mothers at delivery to measure the possible influence of both gestational age and maternal vaccination status. In order to measure the decline of maternal antibodies in the first weeks of life, blood will be taken from cords as well as from infants at 8 weeks of age, before the first infant pertussis vaccine is administered. Pertussis antibodies to the same antigens will be measured in all infants after a primary series of acellular pertussis vaccines administered at 8,12 and 16 weeks of age and before and after a booster dose in the second year of life. In addition, cellular mediated immune responses will be evaluated in a subgroup of infants before and after a primary series of infants vaccines. A last goal is to measure whether vaccination during pregnancy could offer additional maternal antibodies through breast milk. Again a comparison is made between preterm and term born infants, born from either vaccinated or unvaccinated women. The amount of lactoferrin and pertussis toxin specific IgA in breast milk samples will be measured in samples taken at birth (colostrum), and at several time points afterwards as long as breastfeeding is continued.