c

c
·(-.( ,l,,
\ ""'
Weekly Report
A
Date or PublicaUon: July 15, 1989
Date de publication: 15juillet1989
ISSN 0382-232X
Vol.1~28
Contained In this issue:
Contenu du present numero:
Post-marketing Surveillance of Adverse Events Following
ProHIBit® Vaccine- British Columbia . • • . . • . . • . • . • • . . . • • 143
a!'administration du vaccin ProHIBit<9-Colombie·Britannique
Announcements . . . . . . . . . . . . • . • . . . . • . • . • . . • . . . . 145
Annonces .......•..................•.....•..•.•.. 145
Surveillance post-commercialisaUon de manifestations facheuses consecuUves
.........•... 143
POST-MARKETING SURVEILLANCE OF
ADVERSE EVENTS FOLLOWING PROHIBIT®
VACCINE-BRITISH COLUMBIA
SURVEILLANCE POST-COMMERCIALISATION DE
MANIFESTATIONS FACHEUSES CONSECUTIVES A
L'ADMINISTRATION DU VACCIN PROHIBIT® COLOMBIE·BRITANNIQUE
Haemophilus b diphtheria toxoid conjugate vaccine
(ProHIBit®, Connaught Laboratories) was licensed for use in
Canada early in 1988. The National Advisory Committee on
Immunization recommends its use in children 18-60 months
old(l). As pre-licensure data on the safety of new vaccines are
necessarily limited, it is valuable to have systematically collected
information from large numbers of recipients of newly licensed
products. We report here the results of a study of over 5000
recipients of ProHIBit® vaccine which confirm the safety of the
vaccine.
Le vaccin anti-Haernophilus b conjugue al'anatoxine diphterique
(ProHIBil®, Laboratoires Connaught) a ete autorise au Canada au debut de
1988, et le Cornite consultatif national de l'inununisation le recommande
pour les enfants de 18 60 mois(l). Les donnees pre-autorisation sur la
securite des nouveaux vaccins etant forcernent limitees, ii est utile de
recueillir systematiquement des renseignements sur de grands nombres de
vaccines ayant reyu des preparations riouvellement autorisees. Le present
article fait etat des resultats d 'une etude qui a ere rnenee chez plus de
5 000 sujets ayant re1;u le vaccin ProHIBit® et qui confirme la securite de
la preparation.
Children receiving ProHIBit® vaccine in clinics of 3 public
health units in the lower mainland of British Columbia were
invited to participate in a post-licensure study of adverse
reactions designed by ConnaughtLaboratories. Subjects were
enrolled between April and December of 1988. With their prior
informed consent, parents/guardians were telephoned by study
Des enfants vaccines avec ProHIBit® dans les cliniques de 3 services
de sante publique du Lower Mainland de la Colombie-Britannique ont ere
invites participer une etude post-autorisation COnyUe par }es
Laboratoires Connaught et axee sur Jes reactions defavorables. Les sujets
ont ete inscrits entre avril et decernbre 1988. Les parents et tuteurs ayant
donne leur consenternent eclaire, des infinnieres de I' etude leur ont
a
a
a
Table 1
Tableau 1
Demographic Characteristics of ProHIBlt® Vaccine Recipients by Health Unit
Caracterlstlques demographlques de receveurs du vaccin ProHIBlt®, par service de sante
Boundary and Central
Fraser Health Units/
Services de sante
Boundary et Central Fraser
Sex/Sexe F/M
Age/Age (X ±SD/ET)* - months/mois
Race Caucasian/blanche
Asian/asiatique
Mixed/metisse
Other/autre
Unknownlinconnue
Other Vaccine Received at Same Time
Autre vaccin administre simultanement
Other Vaccine Within 30 Days
Autre vaccin administre dans un delai de 30 jours
1741/1802
28.0 ± 9.4
3188
155
91
19
90
36
153
Simon Fraser Health
Unit/Service de
sante Simon Fraser
843/877
27.7 ± 9.5
1391
85
34
62
148
0
8
Total
2584/2679
27.9 ±9.4
4579
240
125
81
239
36
161
• mean ± standard deviation
• moyenne ± ecart-type
I Seoood
l+I
'~
Classt.W Regisualion No. 5670
Health and Welfare
Canada
I
Santa et Bien-etre social
Canada
:
Rapport hebdomadaire des · ·, ·.· ·.' ·
Lr{.
• au canad a ,1f'jjlL 6 ,1-;; ;'f!i'.:1:
ma Ia d ies
1.::1c,!~
Canada Diseases
I
143
Camie< de la deuxiemeclasse-Enregisu001entn' 5670
Canad~
nurses approximately 30 days post-immunization. Parents were questioned
in a standardized fashion about adverse events occurring in their children
during the first 48 hours after immunization (instituted during the second
month of the study) and about any illnesses requiring doctor's care or
hospitalization during the 30 days after immunization. Particular care was
exercised to identify hospitalized subjects who might have experienced
Haemophilus injluenzae type b (HIB) infection, as preliminary reports(2)
suggested a possible increase in the risk of HIB infections in recipients of
an earlier plain polysaccharide vaccine against HIB within 30 days of
immunization. Details of serious infections were obtained through family
physicians with parents' consent.
telephone environ 30 jours apres la vaccination. Les parents ontdi'i
repondre compter du second mois de l 'etude) un questionnaire
normalise sur les manifestations fiicheuses observees chez leurs enfants
pendant les 48 heures suivant la vaccination, ainsi que sur toute atteinte
ayant necessite des soins medicaux ou une hospitalisation dans les 30 jours
suivant la vaccination. Une attention particuliere a ete accordee a
l' identification de sujets hospitalises ayant pu presenter une infection a
Haemophilus injluenzae de type b (HIB), des rapports preliminaires(2)
suggerant une hausse possible du risque de telles infections chez Jes
receveurs d 'une preparation anterieure de vaccin polysaccharidique
ordinaire contre HIB dans les 30 jours suivant l' administration. Des details
SUI Jes infections graves Ont ete obtenus des medecins de famille, avec Je
consentement des parents.
Completed reports were obtained for 5263 subjects, 3543 from
Boundary and Central Fraser Valley Health Units (serviced by one team of
research nurses) and 1720 from Simon Fraser Health Unit (serviced by
another research team). Both research teams had prior experience with
vaccine studies and used the same questionnaire and interview techniques.
There was no difference between the health unit study populations in
terms of sex, age or racial mix (Table 1). In both groups, children 18-24
months of age comprised 38% of the total. ProHIBi~ vaccine was
administered alone to over 99% of subjects; others received DPT vaccine
concurrently or within 30 days.
Des rapports di'iment remplis ont ete communiques sur 5 263 sujets, so it
3 543 des services de sante de Boundary et de Central Fraser Valley (qui
partagent une equipe d'infirmieres de recherche) et 1 720 du Service de
sante Simon Fraser (dote d'une autre equipe de recherche). Les 2 equipes
avaient deja participe des etudes sur des vaccins, et ont utilise le meme
questionnaire et Jes memes techniques d 'interview. II n'y avait aucune
difference entre Jes populations etudiees, ni Sur le plan du SeXe OU de J' age,
ni SUI celui de la combinaison de races (Tableau 1). Dans les 2 groupes, les
enfants de 18 24 mois representaient 38% du total. Le vaccin ProHIBit® a
ete administre seul plus de 99% des sujets; d'autres ontreyu le vaccin
DCT en meme temps OU clans ]es 30 jours suivants.
Questioning about acute adverse events was undertaken for 4677
consecutive subjects, from the second month of the study onwards.
Specific reported events are summarized in Table 2. Only 9 subjects
(0.17%) sought medical attention for these or other systemic symptoms.
Injection site reactions were recalled by parents of 2.3% of subjects; only
3 had reactions warranting medical attention (0.06%). No serious allergic
reactions were reported but 5 children developed hives-like rashes within
48 hours of immunization. Eleven cases of hives-like rash occurred 11-20
days post-immunization suggesting the possible occurrence of
immunologically mediated rashes in occasional vaccinees. Rashes were
not accompanied by fever or joint symptoms.
Un questionnaire sur les manifestations fil.cheuses aigues a ete
administre consecutivement 4 677 sujets, compter du deuxierne mois de
l' etude. Le Tableau 2 resume Jes reactions specifiques signalees. Neuf
sujets seulement (0, 17%) ont consulte un medecin pour ce genre de
manifestations ou d' autres symptomes systemiques. Les parents d~ 2,3%
des sujets se sont souvenus avoir observe une reaction au point d'injection;
de ces cas, 3 seulement ont necessite des so ins medic aux (0,06% ). Aucune
reaction allergique grave n'a ete signalee, mais 5 enfants ont developpe
une pseudo-urticaire dans les 48 heures suivant l'immunisation. Onze
enfants ont presente ce type d' eruption entre 11 et 20 jours apres la
vaccination, ce qui suggere la survenue possible d 'eruptions d' origine
imrnunologique chez de rares vaccines. Les eruptions ne s'accompagnaient
ni de fievre, ni de symptomes articulaires.
(a
a
a
a
a
a
a
Table2
Tableau 2
Reported Adverse Events Within 48 Hours of ProHIBil® Vaccine in 4677 Subjects
Manifestations fiicheuses signalees dans les 48 heures suivant la vaccination par ProHIBil® de 4677 su)ets
Boundary and Central
Fraser Health Units/
Services de sante
Boundary et Central Fraser
147
Simon Fraser Health
Unit/Service de
sanle Simon Fraser
77
Total(%)
224 (4.8)
1.49 ± 0.91
1.53±0.75
1.5 ± 0.98
24
14
6
5
13
4
2
0
Soreness/Endolorissement
62
26
VomitingNomissement
15
9
24 (0.5)
Appetite Loss/Perte d'appetit
43
19
62 (1.3)
261
89
8
350 (7.5)
Adverse Event/
Manifestation fiicheuse
Fever/Fievre
Fever Duration (da~s)
Duree de la fievre 'ours)
(x±SD/Elt
Redness/Rougeur
Redness Size/
Dimension de la rougeur
<5 cm
~5 cm
unknown/inconnue
Crankiness/Mauvaise humeur
Rash/Eruption
29
• mean ±standard deviation
• moyenne ± ecart-type
144
38 (0.8)
10
7
13
88 (1.9)
37 (0.8)
During the 30 days after immunization, 645 children (12.3%) attended
a doctor, but in over 90% of these visits the indication was clearly
unrelated to immunization. These included ear infection (153 subjects),
cold/cough (146 subjects), sore throat (76), vomiting/diarrhea (61), rash
(58), and fever (29). The distribution of such complaints was uniform
between days 2 and 30 of observation, except for rashes. Thirteen subjects
were admitted to hospital but only one had a syndrome consistent with
RIB infection. That child of 19 months had culture-proven HIB meningitis
and otitis media diagnosed 2 days post-immunization, in association with
symptoms of viral upper respiratory infection. The observed rate of one
case of invasive RIB infection in 5263 child-months of observation did not
differ significantly from the predicted rate of 0.14 cases in such a group.
The case of RIB infection does not represent a vaccine failure because an
interval of 2 or more weeks post-immunization is required for
development of immunity.
Pendant les 30 jours qui ont suivi leur vaccination, 645 enfants (12,3%)
ont consulte un medecin; cependant, dans plus de 90% des cas, le motif de
la visite n' avait absolument aucun lien avec le vaccin. Il s 'agissait en effet
d'infection de l'oreille (153 sujets), de rhume ou de toux (146), de mal de
gorge (7 6), de vomissements et de diarrhee (61 ), d 'eruption cutanee (58),
et de fievre (29). Al'exception des eruptions cutanees, ces plaintes se
repartissaient uniformement entre le 2e et le 30e jour d'observation. Treize
sujets ont ete hospitalises, mais 1 seulement a presente un syndrome
compatible avec une infection a RIB. Il s'agissaitd'un enfant de 19 mois
atteint d'une meningite a HIB confirmee par culture et d 'une otite
moyenne diagnostiquee 2 jours apres la vaccination, en association avec
des symptomes d'infection virale des voies respiratoires superieures. Le
tauxrecense d'infection invasive a RIB, c'est-a-dire 1 cas pour 5 263
mois-enfants d'observation, ne differait pas de fayon significative du taux
prevu pour un tel groupe, soit 0,14 cas. Ce cas d'infection a RIB n'est pas
un echec vaccinal, puisqu 'il faut au moins 2 semaines pour que l 'immunite
se developpe apres la vaccination.
In summary, ProRIBit® vaccine was well tolerated by the children in
this study. Injection site symptoms were reported in 2.3% and were
generally minor. Systemic symptoms were reported in 9.6% but were
usually mild. Only 12 subjects sought medical attention for local or
systemic symptoms: none required !Jospital admission. Invasive HIB
infection developed in one subject which was consistent with the expected
rate of RIB disease.
En resume, les enfants de l' etude ont bien tolere le vaccin ProRIBit®.
Au total, 2,3% des vaccines ont signale des symptomes au point
d'injection, et 9,6% des sympmmes systemiques; il s'agissait generalement
de manifestations benignes. Douze sujets seulement ont consulte un
medecin en raison de symptomes localises ou systemiques; aucun n' a du
etre hospitalise. L'infection invasive a RIB s' est manifesree chez un sujet,
ce qui est conforme au taux prevu d' atteinte par RIB.
References:
References:
1.
2.
National Advisory Committee on Immunization. Canadian
Immunization Guide. 3rd ed., Ottawa, Ont: Department of National
Health and Welfare, 1989:45-8. (Supply and Services Canada, Cat
No H49-8/1989B).
Murphy TV. Haemophilus b polysaccharide vaccine: need/or
continuing assessment. Pediatr Infect Dis 1987; 6:701-3.
1.
Comite consultatif national de l 'immunisation. Guide canadien
d' immunisation, 3e ed., Ottawa (Ont.): minisrere de la Sante nationale
et du Bien-etre social, 1989: 53-6. (Approvisionnements et Services
Canada, n° de cat. H49-8/1989F.)
2.
Murphy TV. Haemophilus b polysaccharidevaccine: need/or
continuing assessment. Pediatr Infect Dis 1987; 6: 701-3.
Source: W Meekison, MD, Director and M Hutcheon, MD, Medical
Officer, Boundary Health Unit, Surrey; R Guasparini, MD,
Director, Central Fraser Valley Health Unit, Langley; M Arnott,
MD, Director, Simon Fraser Health Unit, Coquitlam; D
Scheifele, MD, Director andM Grace, PhD, consultant
statistician, Vaccine Evaluation Center, B.C.' s Children's
Hospital and the University ofBritish Columbia, Vancouver,
British Columbia; G Humphreys, MD and L Barreto, MD,
Medical Department, Connaught Laboratories Ltd, Willowdale,
Ontario.
Source: D's W Meekison, directeur, et M H utcheon, medecin-hygieniste,
Service de sante de Boundary, Surrey; Dr R Guasparini,
directeur, Service de sante de Central Fraser Valley, Langley;
D' M Arnott, directeiir, Service de sante Simon Fraser,
Coquitlam; D'D Scheifele, directeur, et M Grace, PhD,
statisticien-conseil, Centred' evaluation desvaccins,Hopital
pour enfants de la C.-B. et Universite de la ColombieBritannique, Vancouver, Colombie-Britannique; Drs G
Humphreys et L Barreto, departement medical, Laboratoires
Connaught Ltee, Willowdale, Ontario.
Announcements
An nonces
INFECTION CONTROL GUIDELINES
GUIDE DE PREVENTION DES INFECTIONS
The infection control guidelines dealing with the following 5 topics
have recently been revised:
Les directives s 'appliquant aux 5 domaines suivants ont recemment ete
revisees:
1)
2)
3)
Prevention oflntravascular Infections,
Prevention of Surgical Wound Infections,
Prevention ofNosocomial Pneumonia,
1)
prevention des infections intravasculaires,
2)
3)
prevention des infections des plaies operatoires,
prevention de la pneumonie nosocomiale,
4)
Prevention of Urinary Tract Infections, and
4)
prevention des infections des voies urinaires, et
5)
prevention des infections en milieu hospitalier.
5)
Hospital Environmental Control.
Requests for copies should be directed to Sheila Herman, Division of
Infection Control, Bureau of Communicable Disease Epidemiology,
Room SB, Health Protection Branch Building, Tunney's Pature,
Ottawa, Ontario, KIA OL2 (tel (613) 952-8227).
Toute demande d' exemplaire de ce guide doit etre adressee a Shella
Herman, Division de la lutte anti-infectleuse, Bureau de
l'epidemiologie des maladies transmlssibles, piece SB, immeuble de Ia
Protection de Ia sante, Pre Tunney, Ottawa (Ontario), KIA OL2 (tel.:
(613) 952-8227).
145
INTERNATIONAL CONFERENCE FOR THE TENTH
REVISION OF THE INTERNATIONAL CLASSIFICATION
OF DISEASES (ICD-10)
.
CpNFERENCE INTERNATIONALE POUR LA DIXIEME
REVISION DE LA CLASSIFICATION INTERNATIONALE
DES MALADIES (CIM·10)
WHO is at present preparing the International Conference for the Tenth
Revision of the ICD to be held in Geneva from 26 September to 2 October
1989.
L'OMS prepare actuellement la Conference internationale pour la
Dixieme Revision de la CIM qui doit se tenir aGeneve du 26 septembre au
2 octobre 1989.
This Conference will complete several years' preparatory work carried
out by WHO in fulfilling its constitutional responsibility of revising as
necessary the ICD. After nearly 10 years of discussions at various
meetings to decide on a suitable approach towards ICD-10, the first WHO
Expert Committee on ICD-10 held in San Francisco in 1984 recommended
a change in the coding scheme from a numeric to an alphanumeric system.
The first draft proposal for ICD-10 was elaborated on this basis and
circulated to WHO Member States, relevant WHO collaborating centres
and nongovernmental organizations in 1984. At that stage WHO was
mainly interested in soliciting comments on the proposed coding scheme,
the relative amount of space provided for each chapter and the utilization
of space left for expansion and future revisions within chapters.
Cette Conference sera le couronnement de plusieurs annees de
preparatifs effectues par !'OMS pours' acquitter de la responsabilite que lui
con!ere la Constitution de reviser la CIM selon les besoins. AI' issue de
pres de 10 ans d' echanges de vues ]ors de diverses reunions pour decider
de la demarche asuivre en vue de la CIM-10, le premier Comite OMS
d'experts de laCIM-10 arecornmande aSan Francisco en 1984 de
remplacer le systeme de codage numerique par un systeme
alphanumerique. Le premier avant-projet de la CIM-10 a ere elabore sur
cette base et communique aux Etats Membres de !'OMS, aux centres
collaborateurs OMS competents et ades organisations non
gouvemementales en 1984. Ace stade, I 'OMS souhaitait surtout recueillir
des observations sur le systeme de codage propose, sur I' espace relatif
reserve achaque chapitre et sur !'utilisation de l' espace restant pour des
additions et des revisions ulterieures al'interieur des chapitres.
After having summarized and considered the results at different
meetings of the Heads of WHO Collaborating Centres for Classification of
Diseases, WHO circulated the second draft proposal in July 1986 in the
same way as in 1984.
Ayant recapitule et examine Jes resultats !ors de differentes reunions
des directeurs des centres collaborateurs de l 'OMS pour la Classification
des Maladies, l 'OMS a diffuse le deuxieme avant-projet en juillet 1986
dans les memes conditions qu'en 1984.
On the basis of further comments and recommendations received by
WHO, a further draft was prepared and subsequently reviewed by the
second Expert Committee on ICD held in Geneva in November 1987. A
slightly revised draft will be submitted to the International Conference for
the Tenth Revision of the ICD in September 1989 prior to its submission
to the World Health Assembly in 1990 for approval.
Sur la base des nouvelles observations et recommandations re~ues par
!'OMS, un nouveau projet a ete etabli, puis revu par le deuxieme Comite
d 'experts de la CIM reuni aGeneve en novembre 1987. Un projet
legerement revise sera presente ala Conference internationale pour la
Dixieme Revision de la CIM en septembre 1989 avant d'etre soumis a
I' approbation de l' Assemblee mondiale de la Sante en 1990.
Invitations to nominate delegates were sent in January 1989 to WHO
Member States and to nongovernmental organizations in official relations
with WHO that have special interest in the International Classification of
Diseases. Replies had been requested by 31 May 1989.
Les Etats Membres de l'OMS et les organisations non
gouvemementales ayant des relations officielles avec I 'OMS et
s 'interessant particulierement ala Classification intemationales des
Maladies ont ete invites enjanvier 1989 aproposer des delegues. 11 leur
etait demande de cornmuniquer leur reponse au plus tard le 31 mai 1989.
The Revision Conference will also discuss activities related to the
training of coders in different parts of the world, the preparation of
national language versions ofICD-10 as well as the elaboration of
specialty-based adaptations and applications and other parts of the family
of disease and health-related classifications.
La Conference sur la Revision discutera aussi des activites concemant
la formation du personnel charge du codage dans differentes parties du
monde, la preparation de version de la CIM-10 en langue nationale et
I' elaboration d' adaptations et d' applications fondees sur !es specialites et
d' au tr es elements de la famille des classifications relatives aux maladies et
ala sante.
11 est prevu que la CIM-10 sera appliquee dans les pays le 1er janvier
1993.
ICD-10 is expected to be put into use in countries on 1 January 1993.
Source: Re/eve epidemiologiq11e hebdomadaire de l' OMS, Vol 64, n° 20,
1989.
Source: WHO Weekly Epidemiological Record, Vol 64, No 20, 1989.
The Canada Diseasos Weekly Report presents cunentinformation on infectious and
other diseases for surveillance purposes and is available free of charge upon requost.
Many of lhe articles contain preliminary information and further confinnation may
be obtained from the sources quoted. The Department of National Health and
Welfare does not assume responsibility for aecuracy or authmticity. Contributions
are welcome (in the official language of your choice) from anyone working in the
health ficld and will not preclude publication elsewhere.
Le Rapport hcbdomadaire dos maladios au Canada, qui foumit dos donnees
pertinentes sur !es maladies infectieuses et !es autres maladies dans le but de faciliter
!cur surveillance, peut etre obtenu gratuitement sur demande. Un grand nombre
d 'articles ne contiennent que des donnees sommaires mais des renseignemenl5
comp!ementaires peuvent etre obtenus en s'adressant aux sources cities. Le ministere
de la Sant6 nationale et du Bien-etre social nepeut etreresponsable de !'exactitude, ni
de l'authenticite des articles. Toute personne oeuvrant dans le domaine de la sante est
invitee a collaborer (dans la langue officielle de son choix) et la publicatioo d'un
article dans le present Rapport n 'en empeche pas la publication ailleurs.
Dr. S. E. Acres
Scientific Advisor:
Eleanor Paulson
Editor:
Dolly Riggins
Circulatlon:
Deborah Chapman
Desktop Publishing:
Bureau of Communicable Disease Epidemiology
Labontory Centre for Disease Control
Tunney' s Pasture
Conscillersclcntlfique:
RMactrlce en chef:
Distribution:
Editlquc:
(613)
(613)
(613)
(613)
957-0325
957-1788
957-0841
957-7845
D' S.E. Acres
Eleanor Paulson
Dolly Riggins
Deboral1Chapman
Bureau d'epidemiologie des maladies transmissibles
Laboratoire de Jutte contre la maladie
Pre Tunney
Ottawa (Ontario)
Canada KIA OI..2
<JITAWA, Ontario
Canada KIA 01..2
146
(613)
(613)
(613)
(613)
957-0325
957-1788
957-0841
957-7845
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertising