Boostrix

also known as Tdap · Boostrix dTpa · dTpa · Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine

Developed for: diphtheria · tetanus · meningococcal infection · pertussis · rheumatoid arthritis
Investigated by: GlaxoSmithKline · BioNet-Asia Co., Ltd. · Eli Lilly and Company · ILiAD Biotechnologies · Memorial Sloan Kettering Cancer Center · Ministere de la Sante et des Services Sociaux
+4 more
· National Institute of Allergy and Infectious Diseases (NIAID) · Novartis · Novartis Vaccines · St. Justine's Hospital

Trials 31

today NCT06798831 · Ph 3 NCT05116241 · Ph 2 NCT05073003 · Ph 1/2 NCT03909126 · Ph 4 NCT03589768 · Ph 2 NCT03311659 · Ph 3 NCT02377349 · Ph 4 NCT02543918 · Ph 1 NCT02072525 · Ph 4 NCT01988857 · Ph 3 NCT02052596 · Ph 3 NCT01738477 · Ph 3 NCT01755689 · Ph 3 NCT01767376 · Ph 3 NCT01424644 · Ph 4 NCT01362322 · Ph 4 NCT01147900 · Ph 4 NCT00835237 · Ph 3 NCT00548171 · Ph 4 NCT00505063 · Ph 2 NCT00489970 · Ph 3 NCT00452686 · Ph 3 NCT00406562 · Ph 3 NCT00385255 · Ph 3 NCT00369824 · Ph 3 NCT00346073 · Ph 3 NCT00282295 · Ph 4 NCT00544271 · Ph 4 NCT01294605 · Ph 4 NCT01277705 · Ph 3 NCT01262924 · Ph 3

1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT02543918	Sep → Nov 2015	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1/21 trial · 1 missed
Phase 1/2	NCT05073003	Oct 2021 → Jun 2025	diarrheal disease	GlaxoSmithKline	Completed	Missed primary
Phase 23 trials
Phase 2	NCT05116241	Nov 2021 → May 2024	pertussis	ILiAD Biotechnologies	Completed	No outcome recorded
Phase 2	NCT03589768	Jan 2019 → Jul 2020	Clostridium difficile colitis, diphtheria, pertussis, tetanus	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00505063	Jul 2007 → Jun 2025	childhood malignant neoplasm	Memorial Sloan Kettering Cancer Center	Completed	No outcome recorded
Phase 316 trials · 1 met primary
Phase 3	NCT06798831	Feb → Apr 2025 overdue	—	BioNet-Asia Co., Ltd.	Active not recruiting	No outcome recorded
Phase 3	NCT03311659	Jan → Aug 2018	—	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01988857	Feb → May 2014	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT02052596	Feb 2014 → Jun 2015	herpes zoster	GlaxoSmithKline	Completed	Mixed
Phase 3	NCT01738477	Jan 2013 → Apr 2014	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01755689	Jan 2013 → Apr 2014	meningococcal infection	GlaxoSmithKline	Completed	Mixed
Phase 3	NCT01767376	Jan 2013 → Jan 2014	meningococcal infection	GlaxoSmithKline	Completed	Mixed
Phase 3	NCT00835237	Feb → Jul 2009	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00489970	Jun 2007 → Sep 2011	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00452686	Mar → May 2007	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00406562	Jan → Feb 2007	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00385255	Oct 2006 → Feb 2007	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00369824	Sep 2006 → Nov 2007	human papilloma virus infection	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT00346073	Jul 2006 → Mar 2007	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01277705	Jan → Apr 2002	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01262924	Oct 1997 → Dec 1998	—	GlaxoSmithKline	Completed	No outcome recorded

Phase 410 trials · 2 met primary
Phase 4	NCT03909126	Jun 2019 → May 2021	pertussis	St. Justine's Hospital	Completed	No outcome recorded
Phase 4	NCT02377349	Oct 2015 → Aug 2017	—	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT02072525	Apr 2014 → Jun 2015	meningococcal infection	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT01424644	Sep 2011 → Dec 2012	meningococcal meningitis	Novartis	Completed	No outcome recorded
Phase 4	NCT01362322	Jul 2011 → Sep 2012	diphtheria, tetanus	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT01147900	Jun 2010 → May 2012	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00548171	Nov 2007 → Apr 2008	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00282295	Jan → Aug 2006	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00544271	May 2003 → Jan 2004	diphtheria, tetanus	GlaxoSmithKline	Terminated	No outcome recorded
Phase 4	NCT01294605	Apr 2003 → Sep 2004	diphtheria, tetanus	GlaxoSmithKline	Completed	No outcome recorded
Comparator or background therapy18 trials
Phase 1	NCT05613205 Comparator	Nov 2022 → Dec 2023	typhoid fever	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT03035370 Background	Sep 2016 → Apr 2018	pertussis	DBV Technologies	Completed	No outcome recorded
Phase 1	NCT02382913 Comparator	Apr → Jun 2015	pertussis	Novartis	Completed	No outcome recorded
Phase 1/2	NCT06997627 Comparator	Jun 2025 → May 2026 overdue	—	GC Biopharma Corp	Recruiting	No outcome recorded
Phase 1/2	NCT02813486 Comparator	Jun → Nov 2016	diphtheria, pertussis, tetanus	Green Cross Corporation	Unknown	No outcome recorded
Phase 1/2	NCT02587520 Comparator	Oct 2015 → Feb 2017	diphtheria, pertussis, tetanus	Sanofi Pasteur, a Sanofi Company	Completed	No outcome recorded
Phase 2	NCT04238975 Comparator	Oct 2019 → Feb 2021	diphtheria, pertussis, tetanus	Green Cross Corporation	Unknown	No outcome recorded
Phase 2	NCT02946190 Comparator	Oct 2016 → Mar 2017	pertussis	University Hospital, Geneva	Completed	No outcome recorded
Phase 2	NCT02676895 Comparator	Aug 2016 → Mar 2017	shigellosis	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT02753413 Comparator	Apr → Jun 2016	respiratory syncytial virus infectious disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT02360475 Comparator	Mar → Jul 2015	respiratory syncytial virus infectious disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT02587221 Comparator	Sep 2016 → Jul 2018	influenza	Seqirus	Completed	Missed primary
Phase 4	NCT02555540 Comparator	Aug → Dec 2015	—	University Hospital, Ghent	Completed	No outcome recorded
Phase 4	NCT02408926 Background	Apr 2015 → Aug 2018	pertussis	University of Antwerp	Completed	No outcome recorded
Phase 4	NCT02526394 Comparator	Sep 2013 → Mar 2017	meningococcal meningitis, pertussis	Public Health England	Completed	No outcome recorded
Phase 4	NCT01698346 Comparator	Feb 2012 → Dec 2015	pertussis, pregnancy disorder	University of Antwerp	Completed	No outcome recorded
Phase 4	NCT01301703 Comparator	Mar → Dec 2011	rheumatoid arthritis	Tel-Aviv Sourasky Medical Center	Unknown	No outcome recorded
Phase 4	NCT00319553 Comparator	May 2006 → Oct 2008	diphtheria, pertussis, tetanus	Sanofi	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 4

Date	Issuer	Release
2024-01-12	BioNet-Asia Co., Ltd.	Results Effective and safe transfer of maternal antibodies persisting two months postpartum following maternal immunization with different doses of recombinant pertussis-containing vaccines bionet-asia.com ↗ Adverse events were comparable in all vaccine groups.
2023-12-12	BioNet-Asia Co., Ltd.	Results Effective and safe transfer of maternal antibodies persisting two months postpartum following maternal immunization with different doses of recombinant pertussis-containing vaccines bionet-asia.com ↗ Anti-PT and anti-FHA geometric mean concentration (GMC) ratio between infants at birth and mothers at delivery was above 1 in all groups.
2023-06-22	BioNet-Asia Co., Ltd.	Results A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in pregnant women bionet-asia.com ↗ Combined with data from 250 non-pregnant women, all study vaccines containing PTgen were non-inferior to comparator vaccine (Tdap8chem).
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.

All press releases naming this drug 4 releases

Date	Issuer	Release
2024-01-12	BioNet-Asia Co., Ltd.	Effective and safe transfer of maternal antibodies persisting two months postpartum following maternal immunization with different doses of recombinant pertussis-containing vaccines bionet-asia.com ↗
2023-12-12	BioNet-Asia Co., Ltd.	Effective and safe transfer of maternal antibodies persisting two months postpartum following maternal immunization with different doses of recombinant pertussis-containing vaccines bionet-asia.com ↗
2023-06-22	BioNet-Asia Co., Ltd.	A phase 2 randomized controlled dose-ranging trial of recombinant pertussis booster vaccines containing genetically inactivated pertussis toxin in pregnant women bionet-asia.com ↗
2022-10-10	GlaxoSmithKline	US FDA approves BOOSTRIX for immunisation during pregnancy for the prevention of whooping cough in newborn infants gsk.com ↗

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 52 sources stand behind the page.

Field	Value	Cited text
Known as	Boostrix	“Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the...” NCT00346073 ↗ 50 “Two clinical studies were undertaken to evaluate the immunogenicity of an adult-type dTpa booster vaccine (Boostrix by GlaxoSmithKline Biologicals).” PMID 14670310 ↗ Jan 2004 “0.5 ml single dose of Tdap (Tetanus, Diphtheria, Acellular Pertussis Vaccine), BOOSTRIX administered intramuscularly to pregnant women” NCT03589768 ↗ “Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults” NCT01738477 ↗ “Participants received TYPHIM VI as comparator intramuscularly on Day 1, and BOOSTRIX as comparator on Day 169.” NCT05613205 ↗ “Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®.” NCT01424644 ↗ “Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine)” NCT01301703 ↗ “Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)” NCT01698346 ↗ “Healthy participants aged 10-18 years received Boostrix®.” NCT02587520 ↗ “Tdap(BOOSTRIX), Hepatitis B #2” NCT00505063 ↗ “Boostrix + Meningitec” NCT02526394 ↗ Show 40 more sources
Known as	Boostrix dTpa	“Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure...” NCT03035370 ↗
Known as	dTpa	“Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults.” PMID 26075317 ↗ 2015
Known as	Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine	“Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®.” NCT01424644 ↗
Known as	Tdap	“We assessed co-administration of quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid-conjugate vaccine (MenACWY-TT), human papillomavirus 16/18 AS04-adjuvanted...” PMID 29789243 ↗ May 2018 1 “Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®.” NCT01424644 ↗
Modality	Vaccine	“tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine” PMID 21134450 ↗ Dec 2010
Route	Intramuscular	“The Boostrix® vaccine was administered intramuscularly” NCT00282295 ↗