title: Immunogenicity and safety of the new reduced-dose tetanus-diphtheria vaccine in healthy Korean adolescents: A comparative active control, double-blind, randomized, multicenter phase III study.
abstract: OBJECTIVE
  A new reduced-dose tetanus-diphtheria (Td) vaccine was developed in Korea, and phase I and II clinical trials were successfully undertaken. We conducted this double-blind, randomized, multicenter phase III clinical trial to assess the immunogenicity and safety of the new Td vaccine.
  
  
  METHODS
  Healthy adolescents 11-12 years of age were enrolled and randomized to receive the new Td vaccine (study group) or a commercially available Td vaccine (control group). Blood samples were collected prior to and 4 weeks after the vaccination. Between the study and control groups, seroprotection rate, booster response, and geometric mean titer of antibodies against diphtheria and tetanus toxoids were compared after the vaccination. All solicited and unsolicited adverse events and serious adverse events during the 6-week study period were monitored.
  
  
  RESULTS
  A total of 164 adolescents received vaccination, and 156 of them were evaluated to assess immunogenicity. The seroprotection rate and geometric mean titer for antibodies against diphtheria were significantly higher in the study group, whereas those against tetanus were significantly higher in the control group. However, all seroprotection rates against diphtheria and tetanus in the study and control groups were high: 100% against diphtheria and tetanus in the study group, and 98.7% against diphtheria and 100% against tetanus in the control group. No significant differences in the frequency of solicited and unsolicited adverse events were observed between the two vaccine groups.
  
  
  CONCLUSIONS
  The new Td vaccine is highly immunogenic and safe, and this new Td vaccine can be effectively used for preventing diphtheria and tetanus.
authors.affiliation: Department of Pediatrics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Seung Beom
authors.initials: SB
authors.lastname: Han
authors.affiliation: Department of Pediatrics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Jung-Woo
authors.initials: JW
authors.lastname: Rhim
authors.affiliation: Department of Pediatrics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Hye Jo
authors.initials: HJ
authors.lastname: Shin
authors.affiliation: Department of Pediatrics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Sang Yong
authors.initials: SY
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Jong-Hyun
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Hyun-Hee
authors.initials: HH
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Kyung-Yil
authors.initials: KY
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Wonju College of Medicine, Yonsei University, Wonju, Republic of Korea.
authors.forename: Hwang Min
authors.initials: HM
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, Medical School, Chonnam National University, Gwangju, Republic of Korea.
authors.forename: Young Youn
authors.initials: YY
authors.lastname: Choi
authors.affiliation: Department of Pediatrics, Changwon Fatima Hospital, Changwon, Republic of Korea.
authors.forename: Sang Hyuk
authors.initials: SH
authors.lastname: Ma
authors.affiliation: Department of Pediatrics, College of Medicine, Keimyung University, Daegu, Republic of Korea.
authors.forename: Chun Soo
authors.initials: CS
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea.
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Kim
authors.affiliation: Research Center, Green Cross Corporation, Yongin, Republic of Korea.
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Ahn
authors.affiliation: Department of Pediatrics, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea. Electronic address: kjhan@catholic.ac.kr.
authors.forename: Jin Han
authors.initials: JH
authors.lastname: Kang
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood; D002648:Child; D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control*; D004168:Diphtheria Toxoid / Q000276:immunology; D022422:Diphtheria-Tetanus Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000071497:Immunogenicity, Vaccine / Q000276:immunology; D007273:Injections, Intramuscular; D008297:Male; D056910:Republic of Korea; D013742:Tetanus / Q000276:immunology / Q000517:prevention & control*; D013745:Tetanus Toxoid / Q000276:immunology; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods*
chemical_list: D000907:Antibodies, Bacterial; D004168:Diphtheria Toxoid; D022422:Diphtheria-Tetanus Vaccine; D013745:Tetanus Toxoid
keywords: Republic of Korea; diphtheria; diphtheria–tetanus vaccine; tetanus