Trials: Diphtheria-Tetanus-acellular Pertussis Vaccines

Phase 1 N=420 Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years

Pertussis · Whooping Cough · Tetanus

Primary: The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine — 30; 33; 32; 35…

Novartis Vaccines Results Sep 2014 3.4% serious AE View details

Phase 4 N=1,341 US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease

Acellular Pertussis · Tetanus · Diphtheria

Primary: Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies — 427; 405; 425; 412 Participants

GlaxoSmithKline Results Mar 2017 0.2% serious AE View details

Phase 3 N=452 Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants

Tetanus · Acellular Pertussis · Diphtheria

Primary: Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) — 204; 211; 204; 211 Subjects

GlaxoSmithKline Results Oct 2018 7.1% serious AE View details

Phase 3 N=112 Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

Diphtheria · Tetanus · Pertussis

Primary: Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination — 95; 99; 55; 99 Percentage of…

Sanofi Pasteur, a Sanofi Company Results Jun 2009 0.0% serious AE View details

Phase 3 N=3,372 Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

Tetanus · Diphtheria · Pertussis

Primary: Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine — 240; 222; 242; 217…

Sanofi Pasteur, a Sanofi Company Results May 2015 0.7% serious AE View details

Phase 3 N=2,167 Safety and Immune Response of Different Pediatric Combination Vaccines.

Diphtheria · Polio · Pertussis

Primary: Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. — 98; 99; 99; 99 Percentage of…

Sanofi Pasteur, a Sanofi Company Results Nov 2010 3.1% serious AE View details

Phase 4 N=321 A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

Healthy Subjects

Primary: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series — 100.0…

Pfizer Results Feb 2013 3.0% serious AE View details

Phase 4 N=215 Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine

Pertussis · Diphtheria · Tetanus

Primary: Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine — 89; 87; 85; 87 Participants

Sanofi Pasteur, a Sanofi Company Results Apr 2011 0.0% serious AE View details

Phase 3 N=1,042 Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

Tetanus · Diphtheria · Pertussis

Primary: Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level — 65; 69; 100; 100…

Sanofi Pasteur, a Sanofi Company Results Dec 2010 0.9% serious AE View details

Phase 4 N=1,271 Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)

Hepatitis A Virus

Primary: Seropositivity Rate (SPR) to Hepatitis A — 100; 100; 100; 100 Percentage of participants

Merck Sharp & Dohme LLC Results Jul 2011 0.5% serious AE View details

Phase 2 N=43 Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents

Pertussis · Tetanus · Diphtheria

Primary: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® — 100; 100 Percentage of Participants

Sanofi Pasteur, a Sanofi Company Results Feb 2014 0.0% serious AE View details

Phase 3 N=534 Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old

Tetanus · Diphtheria · Pertussis

Primary: Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT — 99.7; 98.3; 100; 93.8 Percentage…

Sanofi Pasteur, a Sanofi Company Results Oct 2015 0.0% serious AE View details

Phase 3 N=303 Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.

Acellular Pertussis · Tetanus · Diphtheria

Primary: Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations — 9.207; 21.393; 12.527; 11.07 IU/mL

GlaxoSmithKline Results Apr 2017 0.0% serious AE View details

Phase 3 N=649 Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

Diphtheria · Tetanus · Pertussis

Primary: Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination — 75; 70; 36; 24 Percentage of Participants

Sanofi Pasteur, a Sanofi Company Results Sep 2009 1.2% serious AE View details

Early Phase 1 N=42 Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women

Pertussis · Pregnancy Related

Primary: The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women — 43 Participants

Mahidol University Results Mar 2020 0.0% serious AE View details

Phase 4 N=1,302 Study of Adacel® Vaccine Administered to Persons 10 Years of Age

Tetanus · Diphtheria · Pertussis

Primary: Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine — 30.1; 32.0; 232; 225 Titers (1/dilutions)

Sanofi Results Apr 2016 0.1% serious AE View details

Phase 4 N=989 Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

Diphtheria · Tetanus · Pertussis

Primary: Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® — 62; 20; 7; 12…

Sanofi Pasteur, a Sanofi Company Results Jan 2010 1.0% serious AE View details

Phase 3 N=551 Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants

Healthy Subjects

Primary: Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter…

Pfizer Results Oct 2012 3.9% serious AE View details

Phase 3 N=2,284 Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

Acellular Pertussis · Diphtheria · Tetanus

Primary: Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies — 1418; 717; 1439; 728 Participants

GlaxoSmithKline Results Aug 2018 1.5% serious AE View details

Phase 2 N=1,363 Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects

Tetanus · Diphtheria · Pertussis

Primary: Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years — 59; 51; 50; 49 Participants

Sanofi Pasteur, a Sanofi Company Results Mar 2020 1.4% serious AE View details

Phase 3 N=1,042 Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

Neoplasms, Glandular and Epithelial · Diphtheria · Tetanus

Primary: Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months) — 416; 417 Participants — p=<0.001

Merck Sharp & Dohme LLC Results Jul 2009 View details

Phase 3 N=702 Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

Haemophilus Influenzae Type b · Diphtheria · Tetanus

Primary: Number of Subjects Reporting Any Solicited Local Symptoms — 130; 120; 89; 134 Participants

GlaxoSmithKline Results Feb 2017 15.4% serious AE View details

Phase 4 N=423 Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

Tetanus · Diphtheria · Pertussis

Primary: Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine — 172; 177; 196; 194…

Sanofi Pasteur, a Sanofi Company Results Oct 2013 0.0% serious AE View details

Phase 3 N=447 Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects

Diphtheria-Tetanus-acellular Pertussis Vaccines

Primary: Number of Seroprotected Subjects for Anti-diphtheria (Anti-D). — 437; 1 Participants

GlaxoSmithKline Results Oct 2019 0.2% serious AE View details

Phase 3 N=4,209 Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

Tetanus · Acellular Pertussis · Diphtheria

Primary: Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects — 16.704; 18.658; 18.437; 18.112 IU/mL

GlaxoSmithKline Results Feb 2020 0.4% serious AE View details

Phase 3 N=394 Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

Hepatitis A

Primary: Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix — 88; 84; 77 Participants

GlaxoSmithKline Results Jul 2009 View details

Phase 3 N=379 Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

Diphtheria · Tetanus · Pertussis

Primary: Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or…

Sanofi Pasteur, a Sanofi Company Results Dec 2013 7.1% serious AE View details

Phase 3 N=310 Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

Hepatitis B · Polio · Diphtheria

Primary: Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines…

Sanofi Pasteur, a Sanofi Company Results Feb 2014 1.6% serious AE View details

Phase 2 N=624 Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Diphtheria · Tetanus · Pertussis

Primary: Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T…

Sanofi Pasteur, a Sanofi Company Results Nov 2013 6.6% serious AE View details

Phase 3 N=843 Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)

Neoplasms, Glandular and Epithelial · Diphtheria · Tetanus

Primary: Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3) — 1151.3; 1244.9 milliMerck units/mL — p=<0.001

Merck Sharp & Dohme LLC Results Feb 2010 0.5% serious AE View details

Clinical Trial Search

Phase 1 N=420 Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years

Phase 4 N=1,341 US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease

Phase 3 N=452 Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants

Phase 3 N=112 Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

Phase 3 N=3,372 Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

Phase 3 N=2,167 Safety and Immune Response of Different Pediatric Combination Vaccines.

Phase 4 N=321 A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

Phase 4 N=215 Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine

Phase 3 N=1,042 Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

Phase 4 N=1,271 Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)

Phase 2 N=43 Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents

Phase 3 N=534 Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old

Phase 3 N=303 Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.

Phase 3 N=649 Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

Early Phase 1 N=42 Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women

Phase 4 N=1,302 Study of Adacel® Vaccine Administered to Persons 10 Years of Age

Phase 4 N=989 Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

Phase 3 N=551 Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants

Phase 3 N=2,284 Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

Phase 2 N=1,363 Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects

Phase 3 N=1,042 Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

Phase 3 N=702 Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

Phase 4 N=423 Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

Phase 3 N=447 Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects

Phase 3 N=4,209 Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

Phase 3 N=394 Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

Phase 3 N=379 Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

Phase 3 N=310 Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

Phase 2 N=624 Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

Phase 3 N=843 Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)