Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine) / GSK - LARVOL DELTA

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=551 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever (clinicaltrials.gov) - P1/2 | N=155 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Infectious Disease

CosTaR: Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Canadian Immunization Research Network | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pertussis • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

Safety Evaluation of Tetanus, Diphtheria, and Acellular Pertussis Vaccine (Tdap) During Pregnancy Among Vietnamese Women. (PubMed, Vaccines (Basel)) - "Background: In Vietnam, the Ministry of Health recently approved the use of Tdap vaccines-Boostrix (2022) and Adacel (2024)-for administration during pregnancy, aiming to provide passive antibody transfer to protect newborns against pertussis and tetanus from birth. This first large-scale Vietnamese cohort provides reassuring evidence on the safety of Tdap vaccination during pregnancy. These findings support broader implementation of maternal Tdap immunization, including concomitant administration with IIV4, to protect both mothers and infants."

Journal • Dermatology • Fatigue • Infectious Disease • Influenza • Obstetrics • Pain • Pertussis • Respiratory Diseases • Tetanus

The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd) (clinicaltrials.gov) - P4 | N=129 | Active, not recruiting | Sponsor: Oregon Health and Science University | Trial completion date: Dec 2025 ➔ Aug 2026 | Trial primary completion date: Jan 2025 ➔ Apr 2025

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Psoriatic Arthritis • Rheumatology • IL17A • IL23A

Should Japanese athletes undergo booster vaccination for pertussis? (PubMed, IJID Reg) - "However, DTaP (diphtheria, tetanus, and acellular pertussis) (TRIBIKⓇ) is the only available vaccine in Japan, which contains higher antigen concentrations than the internationally used Tdap (tetanus, diphtheria, pertussis) vaccines (ADACEL™ and BOOSTRIXⓇ): the antigen contents of pertussis toxin, filamentous hemagglutinin, and diphtheria toxin in TRIBIKⓇ, ADACEL™, and BOOSTRIXⓇ are 23.5 µg/23.5 µg/≤15 µg, 2.5 µg/5 µg/2 µg, and 8 µg/8 µg/2.5 µg, respectively. These differences result in more severe local adverse effects in vaccinees and would complicate booster strategies in Japan. Aligning Japan's immunization policies with international practices represents a critical step toward ensuring individual health and public safety in increasingly globalized sports environments."

Journal • Chronic Cough • Cough • Infectious Disease • Novel Coronavirus Disease • Pertussis • Respiratory Diseases • Tetanus

CosTaR: Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Canadian Immunization Research Network

New P4 trial • Infectious Disease • Pertussis • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus

A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: GC Biopharma Corp | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: GC Biopharma Corp

New P1/2 trial • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Extension study of DV2-TDAP-01 to assess immunogenicity of Tdap-1018 to pertussis antigens. (ANZCTR) - P=N/A | N=57 | Completed | Sponsor: Dynavax Technologies Corporation | Recruiting ➔ Completed

Trial completion • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Acellular Pertussis Vaccine Given in the Week After Birth Does Not Impair Antibody Responses to Later Childhood Doses. (PubMed, Pediatr Infect Dis J) - "A birth dose of acellular pertussis vaccine does not impair antibody responses to booster doses of pertussis vaccines and may be an alternative for protection against early infant pertussis when pertussis booster has not been administered during pregnancy."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pertussis • Respiratory Diseases • Tetanus

A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants (clinicaltrials.gov) - P1 | N=552 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | Phase classification: P1/2 ➔ P1

Enrollment closed • Phase classification

Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults (clinicaltrials.gov) - P1 | N=97 | Completed | Sponsor: GlaxoSmithKline | Recruiting ➔ Completed

Trial completion • Infectious Disease

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children (clinicaltrials.gov) - P2 | N=367 | Completed | Sponsor: ILiAD Biotechnologies | Active, not recruiting ➔ Completed

Trial completion • Cough • Infectious Disease • Pertussis • Respiratory Diseases

Interim safety data from a phase 1/2a, randomized, controlled, observer-blind trial to evaluate the safety, reactogenicity and immunogenicity of a trivalent vaccine against invasive nontyphoidal Salmonellosis (iNTS) and Typhoid Fever in healthy . (ASTMH 2024) - "In stage 1, 50 European adults were randomized in a 2:2:1 ratio to receive either iNTS-TCV vaccine and concomitant saline in different arms, or separate iNTS-GMMA and TCV vaccines in different arms, or placebo and saline in different arms intramuscularly, on Days 1, 57 and 169...Menveo, Boostrix and Typhim Vi are administered as controls for the 1 st , 2 nd and 3 rd doses respectively...In conclusion, based on available data, the anticipated benefit/risk profile of the iNTS-TCV vaccine continues to be positive, with no safety concerns precluding further clinical development. First immunogenicity results are expected later in 2024 and would be presented at the congress."

Clinical • P1/2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain

Phase 1 trial of an investigational Tdap booster vaccine with CpG 1018 adjuvant compared with Boostrix in healthy adults and adolescents. (PubMed, Vaccine) - "Tdap-1018 3000 μg induced similar or higher immune responses than Boostrix. ACTRN12620001177943 (Australian New Zealand Clinical Trials Registry; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12620001177943p)."

Journal • P1 data • Infectious Disease • Pain • Pertussis • Respiratory Diseases • Tetanus

GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age (clinicaltrials.gov) - P2/3 | N=564 | Not yet recruiting | Sponsor: Minervax ApS

Combination therapy • New P2/3 trial • Infectious Disease

Erroneous statement. (PubMed, Reprod Toxicol) - "The composition of the BIKEN acellular pertussis product differs in important ways from the compositions of the acellular pertussis components of Boostrix and Adacel.2 Accordingly, the statement cited above is incorrect. A more appropriate statement might have been, "BVN008 is a booster vaccine similar in concept to the current Tdap vaccines, Boostrix (GSK) and Adacel (Sanofi).""

Journal • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Safety and immunogenicity of a single dose of Tdap compared to Td in pregnant women in Mali and 3 its effect on infant immune responses: a single-centre, randomised, double-blind, active-controlled phase 2 study. (PubMed, EClinicalMedicine) - P2 | "T32AI007524. NIAID, NIH provided Tdap vaccine (BOOSTRIX)."

Journal • P2 data • Allergy • Immunology • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Extension study of DV2-TDAP-01 to assess immuno of Tdap-1018 to pertussis antigens. (ANZCTR) - P=N/A | N=57 | Recruiting | Sponsor: Dynavax Technologies Corporation

New trial • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd) (clinicaltrials.gov) - P4 | N=129 | Active, not recruiting | Sponsor: Oregon Health and Science University | Recruiting ➔ Active, not recruiting | N=400 ➔ 129 | Trial primary completion date: Aug 2024 ➔ Jan 2025

Enrollment change • Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Psoriatic Arthritis • Rheumatology • IL17A • IL23A

Effective and safe transfer of maternal antibodies persisting two months postpartum following maternal immunization with different doses of recombinant pertussis-containing vaccines. (PubMed, Vaccine) - "BioNet licensed (TdaP5 and Tdap2) and candidate vaccines (Tdap1 and ap1) when given to pregnant women in the second or third trimester of gestation are safe and have induced passive pertussis immunity to infants."

Journal • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children (clinicaltrials.gov) - P2 | N=360 | Active, not recruiting | Sponsor: ILiAD Biotechnologies | Recruiting ➔ Active, not recruiting | Phase classification: P2b ➔ P2 | N=600 ➔ 360

Enrollment change • Enrollment closed • Phase classification • Cough • Infectious Disease • Pertussis • Respiratory Diseases

Safety and immunogenicity of SIIPL Tdap, a new tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, in healthy subjects 4-65 years of age: A Phase II/III randomized, observer-blinded, active controlled, multicenter clinical study in Germany. (PubMed, Vaccine) - "Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to the immunogenicity of the vaccine components and was equally well tolerated. EudraCT number: 2019-002706-46."

Journal • P2/3 data • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

A Study on the Effect of Nipocalimab on Vaccine Responses in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Janssen Research & Development, LLC | Active, not recruiting ➔ Completed

Trial completion