PMID- 24852717
OWN - NLM
STAT- MEDLINE
DCOM- 20141218
LR  - 20140610
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 32
IP  - 31
DP  - 2014 Jun 30
TI  - Immunogenicity and safety of one dose of diphtheria, tetanus, acellular pertussis 
      and poliomyelitis vaccine (Repevax(R)) followed by two doses of diphtheria, tetanus 
      and poliomyelitis vaccine (Revaxis(R)) in adults aged >/= 40 years not receiving a 
      diphtheria- and tetanus-containing vaccination in the last 20 years.
PG  - 3942-9
LID - S0264-410X(14)00701-4 [pii]
LID - 10.1016/j.vaccine.2014.05.034 [doi]
AB  - INTRODUCTION: The immunogenicity and safety of one dose of Tdap-IPV (tetanus, 
      diphtheria, acellular pertussis and inactivated poliomyelitis vaccine) and two 
      doses of Td-IPV (tetanus, diphtheria and inactivated poliomyelitis vaccine) were 
      assessed in adults who had not received a diphtheria- and tetanus-containing 
      vaccine in the last 20 years. METHODS: This open-label, multicentre study was 
      conducted in adults aged >/= 40 years with no diphtheria- and tetanus-containing 
      vaccine in the last 20 years. Participants received one dose of Tdap-IPV followed 
      by two doses of Td-IPV (0, 1, 6 month schedule). Primary immunogenicity 
      objectives: to demonstrate acceptable seroprotection rates (percentage of 
      participants with antibody titre above threshold) post-dose 3 for diphtheria (>/= 
      0.1IU/mL by seroneutralization assay [SNA]); tetanus (>/= 0.1IU/mL by enzyme-linked 
      immunosorbent assay [ELISA]); and poliomyelitis (>/= 8 1/dil by SNA); and to 
      evaluate the percentage of participants with an antibody concentration >/= 5EU/mL 
      (by ELISA) for pertussis antigens post-dose 1. Seroprotection rates were 
      acceptable if the lower limit of the 95% confidence interval (CI) was >95%. 
      Percentage of participants with basic clinical immunity against diphtheria (>/= 
      0.01IU/mL) was also assessed. Safety (adverse events [AEs] and serious AEs) was 
      assessed after each dose. RESULTS: Overall, 336 participants were included (mean 
      age: 60.2 years). Post-dose 3 seroprotection rates were: diphtheria, 94.6% (CI 
      91.5-96.8); tetanus and poliomyelitis, 100% (CI: 98.8-100). Percentage of 
      participants with an antibody titre >/= 5EU/mL against pertussis antigens was >/= 
      95.8% for all five pertussis components. Basic clinical immunity against 
      diphtheria was achieved in 100% (CI: 98.8-100) of participants. AEs were reported 
      more frequently following vaccination with Tdap-IPV (post-dose 1: 65.3%) than 
      with Td-IPV (post-dose 2: 48.3%; post-dose 3: 50.3%). CONCLUSIONS: This study 
      highlights the benefits of using Tdap-IPV followed by two doses of Td-IPV in an 
      adult population to achieve maximal protection against diphtheria, tetanus, 
      poliomyelitis and pertussis simultaneously.
CI  - Copyright (c) 2014 Elsevier Ltd. All rights reserved.
FAU - Dominicus, Rolf
AU  - Dominicus R
AD  - Hautzentrum Dulmen, Praxisklinik Doctor Bockhorst/Doctor Dominicus, Vollenstrasse 
      8, 48249 Dulmen, Germany. Electronic address: praxis@hautzentrum-duelmen.de.
FAU - Galtier, Florence
AU  - Galtier F
AD  - National Network of Clinical Investigation in Vaccinology (REIVAC), Institut 
      National de la Sante et de la Recherche Medicale (INSERM), France; Centre 
      d'Investigation Clinique (CIC), INSERM, CHRU Montpellier Hopital Saint-Eloi 80, 
      av. Augustin Fliche, 34295 Montpellier Cedex 5, France. Electronic address: 
      f-galtier@chu-montpellier.fr.
FAU - Richard, Patrick
AU  - Richard P
AD  - Sanofi Pasteur MSD, 162, avenue Jean Jaures, CS 50712, 69367 Lyon Cedex 07, 
      France. Electronic address: PRichard@spmsd.com.
FAU - Baudin, Martine
AU  - Baudin M
AD  - Sanofi Pasteur MSD, 162, avenue Jean Jaures, CS 50712, 69367 Lyon Cedex 07, 
      France. Electronic address: MBaudin@spmsd.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140519
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Antibodies, Viral)
RN  - 0 (DTPP vaccine)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Aged
MH  - Antibodies, Bacterial/blood
MH  - Antibodies, Viral/blood
MH  - Diphtheria/*prevention & control
MH  - Diphtheria-Tetanus-Pertussis Vaccine/*administration & dosage
MH  - Female
MH  - France
MH  - Germany
MH  - Humans
MH  - *Immunization, Secondary
MH  - Male
MH  - Middle Aged
MH  - Poliomyelitis/*prevention & control
MH  - Poliovirus Vaccine, Inactivated/*administration & dosage
MH  - Tetanus/*prevention & control
MH  - Vaccines, Combined/administration & dosage
MH  - Vaccines, Inactivated/administration & dosage
MH  - Whooping Cough/*prevention & control
OTO - NOTNLM
OT  - Boosters
OT  - Immunogenicity
OT  - Safety
OT  - Seroprotection
OT  - Td-IPV
OT  - Tdap-IPV
EDAT- 2014/05/24 06:00
MHDA- 2014/12/19 06:00
CRDT- 2014/05/24 06:00
PHST- 2013/11/11 00:00 [received]
PHST- 2014/05/01 00:00 [revised]
PHST- 2014/05/07 00:00 [accepted]
PHST- 2014/05/24 06:00 [entrez]
PHST- 2014/05/24 06:00 [pubmed]
PHST- 2014/12/19 06:00 [medline]
AID - S0264-410X(14)00701-4 [pii]
AID - 10.1016/j.vaccine.2014.05.034 [doi]
PST - ppublish
SO  - Vaccine. 2014 Jun 30;32(31):3942-9. doi: 10.1016/j.vaccine.2014.05.034. Epub 2014 
      May 19.