Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
104154 (Tdap 0.3-005) IV Phase IV, open, prospective study of the safety of GSK Biologicals' Boostrix® (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) administered to a cohort of adolescents in a US Health Maintenance Organization (HMO) (Post-Marketing Boostrix Safety Study).
105753 (Tdap 0.3-006) IV A phase IV, randomized, partially blinded multicenter study to evaluate the safety and immunogenicity of a booster vaccination with GlaxoSmithKline’s tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap Boostrix®] co-administered intramuscularly with Aventis-Pasteur’s meningococcal (serogroups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra™) as compared to the administration of either vaccine alone in healthy adolescents 11–18 years of age. Boostrix® (Tdap) = GlaxoSmithKline (GSK) Biologicals’ registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum. Menactra™ (MCV4) = Aventis Pasteur’s meningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
263855/019 (dTpa-019) IV Open, non-randomized, phase IV study to evaluate immunogenicity and safety of GlaxoSmithKline Biologicals’ dTpa vaccine when administered as single dose to healthy adolescents in their 11th to 18th year of life who were not previously vaccinated against pertussis and have anti-PT antibody titers < 20 EL.U/ml.
263855/028 (dTpa-028) IV Single-blind, randomized, phase IV clinical trial to compare the immunogenicity of GSK Biologicals’ dTpa vaccine (Boostrix™) and Aventis Pasteur MSD’s tetanus toxoid vaccine (Tetavax®), ten days after vaccination of healthy adults 18 years of age and older
100406 (Tdap 0.3-004) III A phase III, double-blinded, randomized, multicenter, clinical study to assess the safety and immunogenicity of GSK Bio’s Tdap 0.3 mg candidate vaccine when given as a booster dose to healthy school children and adolescents (9-13 years of age), previously vaccinated with a 5th consecutive dose of acellular pertussis-containing vaccine, in studies APV-118 or APV-120
106316 (Tdap 0.3-007) III A phase IIIb, prospective, observer-blind, randomized, controlled multicenter study to evaluate immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap Boostrix®] compared to Sanofi Pasteur’s tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Adacel™], when administered as a booster vaccination in adults aged 19 to 64 years of age. Tdap Boostrix® (Tdap): GSK Biologicals’ combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum. Adacel™ (Ada): Sanofi Pasteur’s combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis adsorbed vaccine.
106323 (Tdap 0.3-008) III A phase IIIb, randomized, controlled, open-labelled, multicenter study of GSK Biologicals’ tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, vaccine (Boostrix®) when co-administered with GSK Biologicals’ influenza vaccine (Fluarix®) in subjects 19 years of age and older. Boostrix® (Tdap): GlaxoSmithKline (GSK) Biologicals’ tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum. Fluarix® (Flu): GSK Biologicals’ inactivated influenza split virus vaccine.
107924 (dTpa-037) III An open study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined reduced antigen content diphtheria-tetanus toxoids and acellular pertussis vaccine (Boostrix™), when given as a booster dose to healthy children aged 6-8 years who were previously vaccinated with four doses of combined diphtheria-tetanus-pertussis (DTP) vaccine in the first two years of life.
108638 (dTpa-038) III A phase III, open, randomised, multicentre study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ combined reduced antigen content diphtheria-tetanus toxoids and acellular pertussis vaccine (Boostrix™) and the Chinese DT vaccine, when administered as booster vaccination in healthy children aged 6-8 years who were previously vaccinated with four doses of combined diphtheria-tetanus-pertussis (DTP) vaccine in the first two years of life. Boostrix™ (dTpa): GSK Biologicals’ combined reduced antigen content diphtheria-tetanus toxoids and acellular pertussis vaccine. DT vaccine: adsorbed diphtheria and tetanus toxoid vaccine manufactured in China by Wuhan Institute of Biological Products (WIBP).
110080 (Tdap 0.3-009 Ext: 007 Year 1) III A phase IIIb, controlled, multicenter study to evaluate antibody persistence at 1, 3, 5 and 10 years following administration of a single dose of Tdap vaccine to healthy subjects, 19 years of age and older in the study 106316 (Tdap 0.3-007). Tdap Boostrix® (Tdap): GlaxoSmithKline (GSK) Biologicals’ combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed, containing 0.3mg aluminum.
263855/001 (dTpa-001) III Single-blind, randomised clinical study to assess and compare the immunogenicity and reactogenicity of the SB Biologicals’ dTpa, Pa and pa vaccines, and two commercial Td vaccines when administered as a booster dose to healthy adolescents 10 to 18 years old, previously vaccinated with the DTP whole cell vaccine (DTPw) in the first three years of life.
263855/002 (dTpa-002) III Single-blind, randomised clinical study of the immunogenicity and reactogenicity of SB Biologicals’ dTpa, pa vaccines and a Td vaccine, given as a booster dose to healthy adults, from the age of 18 years onwards.
263855/004 (dTpa-004) III Randomised clinical study of the consistency of three lots of SB Biologicals’ dTpa vaccine in terms of immunogenicity and reactogenicity, and of the immunogenicity and reactogenicity of SB Biologicals’ pa vaccine and Lederle’s Td vaccine when administered as a booster dose to healthy adolescents at the age of 10 to 14 years.
263855/012 (dTpa-012) - 263855/018(dTpa-018) - 263855/021(dTpa-021) - 263855/026(dTpa-026) - 263855/027(dTpa-027) III Single-blind clinical study of the immunogenicity and reactogenicity of GSK Biologicals’ dTpa, pa vaccines and a Td vaccine, given as a booster dose to healthy adults, from the age of 18 years onwards. dTpa: GlaxoSmithKline (GSK) Biologicals’ reduced-antigen-content combined diphtheria and tetanus toxoids and acellular pertussis vaccine. pa: GSK Biologicals’ stand-alone acellular pertussis vaccine. Td: GSK Biologicals’ combined adult diphtheria and tetanus vaccine.
263855/017, 263855/030 (dTpa-017, dTpa-030) III Open, five-year immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa vaccine or GSK Biologicals’ pa vaccine and Lederle’s Td vaccine at 10 to 14 years of age in study 263855/004 (EXT: dTpa-004). dTpa: GlaxoSmithKline (GSK) Biologicals’ reduced-antigen-content combined diphtheria and tetanus toxoids and acellular pertussis vaccine. pa: GSK Biologicals’ acellular pertussis vaccine. Td: Wyeth’s (formerly Lederle) combined adult diphtheria and tetanus vaccine.
263855/020 (dTpa-020) III An open, phase III, single center study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ dTpa vaccine administered as a single-dose booster in healthy adults aged ³ 18 years.
263855/027(dTpa-027) III Single-blind clinical study of the immunogenicity and reactogenicity of GSK Biologicals’ dTpa, pa vaccines and a Td vaccine, given as a booster dose to healthy adults, from the age of 18 years onwards.
263855/030 (dTpa-030) III Open, five-year immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa vaccine or GSK Biologicals’ pa vaccine and Lederle’s Td vaccine at 10 to 14 years of age.
263855/033 (dTpa-033) III Double-blind, randomised phase IIIb, clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa vaccine (Infanrix™), with GSK Biologicals’ dTpa (Boostrix™) administered to healthy children 4 to 6 years of age, having experienced an injection site reaction (ISR) following the 4th dose of Infanrix™ vaccine.
263855/034 (dTpa-034) III Double-blind, randomized, phase III clinical trial to evaluate the immunogenicity and reactogenicity of three consecutive doses of dTpa, or of dTpa-IPV followed by two doses of Td vaccine, and compared to three consecutive doses of Td vaccine administered to healthy adults in a 0,1,6-month schedule
263855/035 (dTpa-035) III A randomized, phase IIIb clinical trial to evaluate the immunogenicity, persistence of antibodies, and reactogenicity of GlaxoSmithKline Biologicals’ DTPa (Infanrix™) and dTpa (Boostrix™) vaccines when administered to healthy children aged 18 months previously primed with three doses of Infanrix™ vaccine in the first year of life and compared with placebo (Havrix®Junior).
263855/036 (dTpa-036) III Open, phase IIIb, multicentric, safety and reactogenicity study of GlaxoSmithKline Biologicals’ reduced antigen content combined diphtheria-tetanus-acellular pertussis vaccine (Boostrix™) administered as a booster dose to healthy children 4-6 years of age according to the international recommended prescribing information. Boostrix is a registered trademark of the GlaxoSmithKline group of companies.
711866/001 (dTpa-IPV-001) III A partially blinded, randomized, phase III clinical trial to assess the lot-to-lot consistency of GSK Biologicals’ dTpa- IPV vaccine administered to healthy children 4 to 8 years of age, previously vaccinated with four doses of DTPa or DTPabased combination vaccines and at least 3 doses of OPV or IPV, and compared to GSK Biologicals’ dTpa (Boostrix™) and Pasteur Mérieux’s IPV vaccine (IPV Mérieux®) administered separately. dTpa-IPV: GSK Biologicals’ combined reduced antigen content diphtheria, tetanus, acellular pertussis and inactivated polio vaccine. dTpa (Boostrix™) GSK Biologicals’ combined reduced antigen content diphtheria, tetanus and acellular pertussis vaccine. DTPa: Combined diphtheria, tetanus and acellular pertussis vaccine. IPV (IPV Mérieux®): Pasteur Mérieux’s inactivated polio vaccine. OPV: Oral polio vaccine.
711866/003 (dTpa-IPV-003) III An open, randomized, multicenter, phase III clinical trial to assess the immunogenicity and reactogenicity of GSK Biologicals’ dTpa-IPV vaccine, compared to GSK Biologicals’ dTpa (Boostrix™) and IPV vaccines administered separately, and compared with Aventis Pasteur MSD’s Td-IPV vaccine (Revaxis®) when administered as a single dose to healthy adolescents and adults. Boostrix is a registered trademark of the GlaxoSmithKline group of companies.
711866/005 (dTpa-IPV-005, one year follow-up of dTpa-IPV-001) III Open, 1-year, phase III, immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa-IPV vaccine or GSK Biologicals’ dTpa (Boostrix™) and Pasteur Mérieux’s IPV vaccine (IPV Mérieux®) administered separately, at 4 to 8 years of age in study 711866/001 (dTpa-IPV-001)
776423/001 (Tdap 0.3-001) III A phase III, observer-blinded randomised, multi-centre clinical study of the safety, immunogenicity and consistency of three manufacturing lots of GlaxoSmithKline Biologicals’ candidate Tdap vaccine as compared to a US-licensed Td vaccine (Massachusetts Public Health Biologic Laboratories) when given as a booster dose to healthy adolescents (10-18 years of age).
263855/029 (dTpa-029) II Observer-blind, randomized, phase II clinical trial to assess the immunogenicity and safety of one dose of three formulations of GSK Biologicals’ dTpa vaccine containing 0.5 mg, 0.3 mg and 0.133 mg of aluminum, respectively in healthy adolescents aged 10 to 18 years
711866/002 (dTpa-IPV-002) II Open, randomized, multicenter, phase II clinical trial to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ dTpa-IPV vaccine compared to GSK Biologicals’ dTpa (Boostrix™) and Aventis Pasteur Merck Sharp Dohme’s (MSD) IPV (Imovax Polio®) vaccines administered separately, and to assess the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-IPV (Infanrix-IPV™) vaccine, when administered to healthy adolescents aged 10 to 14 years. Boostrix is a registered trademark of the GlaxoSmithKline group of companies