Drugs / tetanus toxoid

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Refused (EMA) EU (EMA) Hexacima — 2013-02-22 europa.eu ↗
Approved EU (EMA) Tritanrix HepB — 1996-07-19 europa.eu ↗

Trials 13

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT01933776 Aug → Nov 2013 diphtheria, pertussis, tetanus Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 1 NCT00707148 Jan 2009 → May 2012 diphtheria, pertussis, tetanus National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00639639 Feb 2006 → Apr 2017 malignant glioma Gary Archer Ph.D. Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT07600983 May → Nov 2026 expected pneumococcal infection CanSino Biologics Inc. Not yet recruiting No outcome recorded
Phase 1/2 NCT06939777 Apr → Dec 2025 tetanus Sinovac Life Sciences Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT05183516 May → Dec 2023 Alzheimer disease Mindful Diagnostics and Therapeutics, LLC Unknown No outcome recorded
Phase 1/2 NCT05480800 Sep 2022 → Sep 2024 salmonellosis GlaxoSmithKline Completed No outcome recorded
Phase 1/2 NCT02587520 Oct 2015 → Feb 2017 diphtheria, pertussis, tetanus Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 21 trial
Phase 2 NCT00027833 Dec 2001 → ? colorectal cancer Herbert Irving Comprehensive Cancer Center Unknown No outcome recorded
Phase 31 trial · 1 met primary
Phase 3 NCT04490018 Mar 2021 → May 2022 meningococcal infection Sanofi Pasteur, a Sanofi Company Completed Met primary
Phase 42 trials
Phase 4 NCT00287677 Jan 2006 → Jul 2009 HIV infectious disease Germans Trias i Pujol Hospital Completed No outcome recorded
Phase 4 NCT00777257 Apr 2005 → Mar 2007 diphtheria, meningitis, meningococcemia, pertussis +1 Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase not applicable1 trial
— NCT00004735 Feb 2000 → Sep 2006 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Comparator or background therapy7 trials
Phase 1 NCT00369291 Background Sep 2003 → May 2010 germ cell tumor, leukemia, plasma cell neoplasm Masonic Cancer Center, University of Minnesota Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT06302374 Background Mar → Nov 2023 tetanus Genrix (Shanghai) Biopharmaceutical Co., Ltd. Completed No outcome recorded
Phase 2 NCT01187433 Comparator Aug 2010 → Oct 2012 Dengue hemorrhagic fever Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 3 NCT02628886 Background Mar 2016 → Feb 2019 pneumonia London School of Hygiene and Tropical Medicine Unknown No outcome recorded
Phase 4 NCT03606096 Comparator Jan 2019 → May 2022 pertussis London School of Hygiene and Tropical Medicine Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2022-10-10 GlaxoSmithKline Regulatory US FDA approves BOOSTRIX for immunisation during pregnancy for the prevention of whooping cough in newborn infants gsk.com ↗
We’re immensely proud to have the first-ever Tdap vaccine approved by the FDA specifically for this use during pregnancy.

Evidence & citations 26 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as tetanus toxoid “mother is randomised to receive Tetanus Toxoid and infant acellular Pertussis” NCT03606096 ↗
9

“Vaccination (Hepatitis A+B + tetanus toxoid) at week 16” NCT00287677 ↗

NCT00027833 ↗

NCT00369291 ↗

NCT06939777 ↗

NCT02628886 ↗

NCT00004735 ↗

NCT02570347 ↗

NCT06302374 ↗

NCT00639639 ↗

Known as 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) ClinicalTrials.gov intervention name — accepted as the source's own label NCT07600983 ↗
Known as DT-pediatric “tetanus toxoid immunizations (known as DTaP, DT-pediatric, or Td)” NCT00004735 ↗
Known as DTaP “tetanus toxoid immunizations (known as DTaP, DT-pediatric, or Td)” NCT00004735 ↗
Known as Equilis te ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as PCV24 “24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M)” NCT07600983 ↗
Known as PCV24 vaccine “1 dose ( 0.5ml) of PCV24 vaccine (dose M)” NCT07600983 ↗
Known as Tdap “Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) immunization of women in the third trimester of pregnancy represents an opportunity to...” NCT00707148 ↗
2

“Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap Vaccine)” NCT00777257 ↗

“Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular” NCT00777257 ↗

Known as Tetanus toxoid component of hexacima ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of hexavac ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of hexyon ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of infanrix hepb ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of infanrix hexa ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of infanrix penta ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of primavax ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of quintanrix ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of triacelluvax ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of tritanrix hepb ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid component of vaxelis ChEMBL registry synonym — accepted as the source's own label CHEMBL2108875 ↗
Known as Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT05480800 ↗
1

NCT05183516 ↗

Known as Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed “Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap Vaccine)” NCT00777257 ↗
3

NCT00707148 ↗

NCT02587520 ↗

NCT01629589 ↗

Known as Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT04490018 ↗
Known as Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap ClinicalTrials.gov intervention name — accepted as the source's own label NCT01933776 ↗
Known as Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed ClinicalTrials.gov intervention name — accepted as the source's own label NCT01187433 ↗
Modality Vaccine “tetanus toxoid [TT] vaccine” PMID 18752430 ↗ Oct 2008