PMID- 10370805
OWN - NLM
STAT- MEDLINE
DCOM- 19990701
LR  - 20190831
IS  - 0929-693X (Print)
IS  - 0929-693X (Linking)
VI  - 6
IP  - 5
DP  - 1999 May
TI  - [Adverse effects of the vaccines Tetracoq, IPAD/DTCP and DTCP. A French study of 
      regional drug monitoring centers].
PG  - 510-5
AB  - On request of the French Drug Agency, the Regional Pharmacovigilance Center 
      (RPVC) of Tours has been in charge of the analysis of adverse events (AEs) 
      associated with tetravalent vaccines IPAD/DTCP, DTCP and Tetracoq, and reported 
      to the RPVC or to the pharmaceutical companies that produce them. METHODS: All 
      AEs spontaneously reported during use of one of these vaccines to one of the 
      French Pharmacovigilance Centers or to the responsible firms between January 1, 
      1986 and December 31, 1990 were take into account. An AE was noted as "serious" 
      in accordance with the European criteria. The incidence of adverse effects was 
      estimated by evaluating the ratio of adverse effects and the number of sales of 
      the vaccine for the same period. RESULTS: From 1986 to 1990, 631 AEs (with 19 
      duplicate cases) associated with tetravalent vaccines in 606 children (75% < 1 
      year) were reported. The most frequent AEs were: local AEs at the site of 
      injection (43%), neurologic disorders (12%), hyperthermia (10%) and allergic 
      reactions (10%). Serious AEs represented 25% of all AEs and were similar to those 
      usually described with these vaccines, particularly persistent crying (23), 
      febrile seizures (12), apyretic seizures (14), uneasiness (28) and, rarely, shock 
      (3). CONCLUSION: Incidences of AEs reported with pentavalent vaccines are very 
      low, probably underestimated because of the under-notification by prescribers of 
      AEs of vaccines licensed some time ago. It will be interesting to compare these 
      data with AEs of penta- and hexavalent vaccines since they have replaced 
      tetravalent vaccines.
FAU - Jonville-Bera, A P
AU  - Jonville-Bera AP
AD  - Service de pharmacologie clinique, Hopital Bretonneau, Tours, France.
FAU - Autret-Leca, E
AU  - Autret-Leca E
FAU - Radal, M
AU  - Radal M
LA  - fre
PT  - Comparative Study
PT  - English Abstract
PT  - Journal Article
TT  - Effets indesirables des vaccins Tetracoq, IPAD/DTCP et DTCP. Enquete francaise 
      des centres regionaux de pharmacovigilance.
PL  - France
TA  - Arch Pediatr
JT  - Archives de pediatrie : organe officiel de la Societe francaise de pediatrie
JID - 9421356
RN  - 0 (DTPP vaccine)
RN  - 0 (Diphtheria Toxoid)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Pertussis Vaccine)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Tetanus Toxoid)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Brain Diseases/etiology
MH  - Child
MH  - Child, Preschool
MH  - Crying/physiology
MH  - Diphtheria Toxoid/*adverse effects
MH  - *Diphtheria-Tetanus-Pertussis Vaccine
MH  - Drug Industry
MH  - Female
MH  - Fever/etiology
MH  - France
MH  - Humans
MH  - Hypersensitivity/etiology
MH  - Incidence
MH  - Infant
MH  - Injections, Intramuscular/adverse effects
MH  - Male
MH  - Pertussis Vaccine/*adverse effects
MH  - Poliovirus Vaccine, Inactivated/*adverse effects
MH  - Psychomotor Agitation/etiology
MH  - Seizures/etiology
MH  - Shock/etiology
MH  - Skin Diseases/etiology
MH  - Tetanus Toxoid/*adverse effects
MH  - Vaccines, Combined/*adverse effects
EDAT- 1999/06/17 10:00
MHDA- 2000/05/05 09:00
CRDT- 1999/06/17 10:00
PHST- 1999/06/17 10:00 [pubmed]
PHST- 2000/05/05 09:00 [medline]
PHST- 1999/06/17 10:00 [entrez]
AID - S0929693X99805569 [pii]
AID - 10.1016/s0929-693x(99)80556-9 [doi]
PST - ppublish
SO  - Arch Pediatr. 1999 May;6(5):510-5. doi: 10.1016/s0929-693x(99)80556-9.