Adacel (tetanus toxoid/reduced diphtheria toxoid/acellular pertussis vaccine adsorbed) / Sanofi - LARVOL DELTA

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial completion date: Dec 2024 ➔ Aug 2025

Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

HYDRO: A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo (clinicaltrials.gov) - P2 | N=215 | Recruiting | Sponsor: Sanofi | Trial completion date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Apr 2025 ➔ Nov 2025

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

MADI-02: Maternal Determinants of Infant Immunity to Pertussis (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Centre Hospitalier Universitaire Saint Pierre | Trial primary completion date: Dec 2024 ➔ Aug 2025

Trial primary completion date • Infectious Disease • Pertussis • Respiratory Diseases

Pertussis vaccination campaign among health care workers and validity of recall of previous adverse events following immunization. (PubMed, Vaccine) - "We achieved an up-to date pertussis vaccination status in the majority of HCW. However, vaccinating all eligible HCW remains challenging in the absence of mandatory immunization. The recall of previous AE following immunization was poor."

Adverse events • Journal • Infectious Disease • Pain • Pertussis • Respiratory Diseases

10-year Follow-up After a Single Dose Acellular Pertussis Vaccination (clinicaltrials.gov) - P4 | N=90 | Not yet recruiting | Sponsor: Mahidol University

New P4 trial • Infectious Disease • Pertussis • Respiratory Diseases

A Preliminary Study to Evaluate the Immune Response to a Booster Dose of the Adult Tetanus-Diphtheria Vaccine (Td) Available in Iran. (PubMed, Iran J Pharm Res) - "The seroconversion rate of the Iranian Td vaccine was comparable to other common tetanus vaccines, including Tenivac®, Adacel®, Infanrix®, Tetavax®, and Vacteta®. The proportion of suitable candidates for plasma donation, based on minimum (2 IU/mL) and maximum (10 IU/mL) anti-tetanus toxoid antibody titers, was 100% and 45%, respectively."

Journal • Infectious Disease • Pain • Tetanus

Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for the Treatment of Patients With Stage III or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, FAROUT Trial (clinicaltrials.gov) - P2 | N=78 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Sarcoma • Solid Tumor

Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study (clinicaltrials.gov) - P4 | N=28000 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Cervical Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for the Treatment of Patients With Stage III or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, FAROUT Trial (clinicaltrials.gov) - P2 | N=78 | Not yet recruiting | Sponsor: Mayo Clinic

Metastases • New P2 trial • Fallopian Tube Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Sarcoma • Solid Tumor

MADI-02: Maternal Determinants of Infant Immunity to Pertussis (clinicaltrials.gov) - P4 | N=200 | Recruiting | Sponsor: Centre Hospitalier Universitaire Saint Pierre | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pertussis • Respiratory Diseases

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

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women (clinicaltrials.gov) - P4 | N=511 | Active, not recruiting | Sponsor: Farzanah Laher | Not yet recruiting ➔ Active, not recruiting | N=225 ➔ 511

Enrollment change • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • Pertussis • Respiratory Diseases

Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: ABO Holdings, Inc. | Enrolling by invitation ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

OPTIWIN: Optimising Protection for Pregnant Women and Infants With Maternal Vaccination (clinicaltrials.gov) - P=N/A | N=73 | Active, not recruiting | Sponsor: Women's and Children's Hospital, Australia | Unknown status ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity • IFNG • IL6

HYDRO: A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo (clinicaltrials.gov) - P2 | N=166 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial (clinicaltrials.gov) - P4 | N=5000 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Cervical Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

Safety and Clinical Benefits of Adacel and Adacel-Polio Vaccination in Pregnancy: A Structured Literature Review. (PubMed, Infect Dis Ther) - "In safety studies, Adacel or Adacel-Polio vaccination was well tolerated by pregnant woman and not associated with pregnancy, postpartum, or neonatal complications. In conclusion, Adacel or Adacel-Polio vaccination in pregnancy is highly effective in protecting young infants from pertussis disease, with a favorable safety profile for both pregnant women and their infants."

Journal • Review • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

HYDRO: A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo (clinicaltrials.gov) - P2 | N=166 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Jennifer Woyach | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Immune Modulation • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • TP53

Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors (clinicaltrials.gov) - P2 | N=100 | Enrolling by invitation | Sponsor: ABO Holdings, Inc. | Not yet recruiting ➔ Enrolling by invitation

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

Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis. (PubMed, Vaccine) - P=N/A | "Tdap5 vaccination in pregnancy between 27 and 36 weeks' gestation is highly effective at protecting young infants from pertussis."

Journal • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

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 (clinicaltrials.gov) - P4 | N=273 | Completed | Sponsor: Sanofi | Recruiting ➔ Completed

Trial completion • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus • CD4 • IL4

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 (clinicaltrialsregister.eu) - P4 | N=350 | Sponsor: Sanofi Pasteur

New P4 trial • Dermatology • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus • CD4 • IL4

Effect of maternal immunisation with multivalent vaccines containing inactivated poliovirus vaccine (IPV) on infant IPV immune response: A phase 4, multi-centre randomised trial. (PubMed, Vaccine) - "To assess the impact of maternal DTaP/IPV immunisation on the infant immune response to IPV, we measured poliovirus-specific neutralising antibodies at 2, 5 and 13 months of age in a randomised, phase 4 study of Repevax or Boostrix/IPV in pregnancy and in a non-randomised group born to women not given DTaP/IPV in pregnancy...At 13 months of age, 63/110 (57.2 %), 46/108 (42.6 %) and 40/108 (37.0 %) were seropositive to types 1 to 3, compared with 20/22 (90.9 %), 20/22 (90.9 %) and 14/20 (70.0 %) (p-values 0.003, <0.001 and 0.012). UK infants whose mothers are given DTaP/IPV in pregnancy may be insufficiently protected against poliomyelitis until their pre-school booster."

Journal • P4 data • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus