Diphtheria and tetanus toxoids 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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diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
100484 (DTPa) IV An open prospective study of immunogenicity and reactogenicity of DTPa vaccine (Infanrix) given as a booster to healthy school children 10 to 12 years of age
101197 (DTPa -127) IV An open, multicentric, phase IV clinical trial to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis vaccine (Infanrix™) administered to healthy infants at 2, 4 and 6 months of age.
102038 (DTPa-130) IV Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.
208355/117 (APV-117) IV A study of the safety and immunogenicity of initiating a primary vaccination series of DTPa administered at 2, 4, and 6 months of age with Tripedia® and completing the series with Infanrix®
104871 (DTPa-IPV-053) III An open, phase IIIb, randomized, multicentric clinical trial to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ DTPa-IPV vaccine versus co-administration of GSK Biologicals’ DTPa vaccine and Sanofi-Pasteurs’ IPV vaccine at different injection sites, to healthy children at 2, 4 and 6 months of age. Infanrix-IPV (DTPa-IPV): GSK Biologicals’ combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine. IMOVAX Polio® (IPV): Sanofi Pasteur’s inactivated poliovirus vaccine.
208355/022 (APV-039) III Double-blind randomised comparative assessment of the immunogenicity and reactogenicity of three different lots of SmithKline Beecham Biologicals´ combined diphtheria, tetanus, acellular pertussis vaccine (PT 25µg + FHA 25µg + 69kDa 8µg). The vaccine will be administered to healthy infants as a primary vaccination course of three consecutive doses at 3, 4 and 5 months of age.
208355/050 (APV-050) III Prospective Household Contact Study to compare the frequency of clinical pertussis disease following household exposure in children previously vaccinated with a primary course of 3 doses of SmithKline Beecham Biologicals’ combined acellular tricomponent DTPa vaccine and in children not immunized against pertussis.
208355/120 (APV-120) III Clinical study of the reactogenicity and immunogenicity of SB Biologicals’ DTPa vaccine administered as a booster to healthy children 4 to 6 years of age, previously vaccinated with four doses of SB Biologicals’ DTPa vaccine in the first two years of life
208355/122 (APV-122) III Open prospective clinical study to assess the reactogenicity and immunogenicity of SB Biologicals’ APV vaccine administered as a booster dose to healthy children of 10-11 years of age (11 years included) previously primed with three doses of DTP whole cell vaccine.
208355/123 (APV-123) III A phase III, open, multicenter study of the safety and immunogenicity of a booster dose of SmithKline Beecham Biologicals’ Diphtheria and Tetanus toxoids and acellular Pertussis (DTaP) vaccine (Infanrix®) and Pasteur Mérieux’s Haemophilus influenzae type b (Hib) conjugate vaccine (OmniHIB®) when administered intramuscularly as separate injections between 12 and 18 months of age following primary immunization at 2 months, 4 months, and 6 months of age in study DTPa-HBV-IPV-027 (CPMS N° 217744/027)
208355/124 (APV-124) III An open, 3.5 year, immunogenicity follow-up of subjects who previously received GSK Biologicals’ dTpa vaccine (BoostrixTM) or GSK Biologicals’ DTPa vaccine (InfanrixTM) or Chiron Behring’s Td vaccine (Td-Pur®) + either Pasteur Merieux’s Pa vaccine (Pac Merieux®) or GSK Biologicals’ pa vaccine, administered as a booster dose at age 4 to 6 years in study 208355/118 (APV-118)
208355/125 (APV-125) III A phase III, open, multicenter study of the safety of Infanrix® when administered as a booster dose at 15 to 18 months of age following primary immunization in studies 217744/084 and 217744/085 (Subjects from DTaP-HepB-IPV-084 and DTaP-HepB-IPV-085)
208355-101 (APV-039B) III Double-blind randomised comparative assessment of the immunogenicity and reactogenicity of three different production lots of SmithKline Beecham Biologicals’ combined diphtheria, tetanus, tricomponent acellular (PT 25 µg + FHA 25 µg + PRN 8 µg) vaccine administered as a booster dose in healthy 15 to 24 month old children previously primed with the same type of vaccine at 3,4 and 5 months of age
213503/045 (DTPa-IPV-045) III Open, randomized, phase IIIb, multi-site, clinical study to compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-IPV vaccine, with GSK Biologicals’ DTPa (Infanrix™) and Aventis MSD’s IPV vaccine (Imovax Polio®) administered separately to healthy children 4 to 6 years of age, previously vaccinated with three doses of DTPa and IPV or OPV vaccines during the first year of life in a 3, 5 and 11 to 12 month schedule.
213503/046 (DTaP-IPV-046) III Open, randomised phase IIIb, clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ DTaP-IPV vaccine (INFANRIX®-IPV), with GSK Biologicals’ DTaP (INFANRIX®) and Aventis Pasteur MSD’s IPV vaccine (IPOL®) administered separately to healthy children 4 to 6 years of age, previously vaccinated with 4 doses of DTaP and polio vaccine, and co-administered with GSK Biologicals’ MMR vaccine (PRIORIX™).
213503/048 (DTPa-IPV-048) III A phase III, open (double-blind for consistency lots), randomized, multicenter, clinical trial of the safety, immunogenicity and consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine compared to that of separate injections of GSK Biologicals' DTaP vaccine (Infanrix®) and Aventis Pasteur's IPV vaccine (IPOL®) administered as booster doses to healthy children 4 to 6 years of age, each co-administered with Merck and Company's MMR vaccine (M-M-R®II). DTaP-IPV: GlaxoSmithKline (GSK) Biologicals' combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine. Infanrix®: GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis vaccine (DTaP) IPOL®: Sanofi Pasteur's inactivated poliovirus vaccine (IPV) M-M-R®II : Merck and Company's licensed combined measles-mumps-rubella vaccine (MMR)
208355/118 (APV-118) II Randomised, blinded clinical study to assess the immunogenicity and reactogenicity of SB Biologicals’ dTpa and DTPa vaccines and a commercial Td vaccine administered as a booster dose to healthy children 4 to 6 years old, previously vaccinated with four doses of SB Biologicals’ DTPa vaccine in the first two years of life
213503-047 II Open, randomized, phase II, clinical trial to compare the immunogenicity and safety of a booster dose of an experimental vaccine co-administered with a booster dose of Merck and Company's M-M-R?II, to that of separate injections of GSK Biologicals' DTaP vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R?II administered as booster doses to healthy children 4 to 6 years of age.