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Epaxal

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gogogoo
0
quote:

josti5 schreef:

[quote=gogogoo]
[quote=soldaat]
In een brede markt kan het interessant zijn om je product goedkoper aan te kunnen bieden. Halve dosering (met hetzelfde effect) is immers minder duur.
Lager of korter doseren is overigens erg hip op dit moment, vooral voor antibiotica. Artsen willen erg echter niet zo snel aan, je weet immers maar nooit.
[/quote]
Dat maakt het vaccin speciek ook geschikt voor kinderen tussen 1 en 2.
Daarnaast zou mogelijk de dosis verlaagd kunnen worden voor 2 tot 16 jarigen.

Hoho: het betreft, zoals vorige week op de analistenmeeting al aangekondigd, gewoon een produkt-uitbreiding: een dosering voor kinderen.
Met dit onderzoek wil men aantonen, dat de gebruikte dosering bij kinderen even effectief is als de bestaande dosering voor volwassenen.
Nu is Epaxal alleen nog maar beschikbaar voor volwassenen, en Crucell wil dit uitbreiden met de kindergroep: 1 - 16 jarigen.
[/quote]
In de bijsluiter staat dat je het niet mag gebruiken bij kinderen onder 2 jaar.
www.consumed.nl/?leftUrl=L2RhdGFiYXNl...
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2
Krachtig spul dat Epaxal!!

A long-term follow up of a phase II open, randomised, controlled study to evaluate the safety and immunogenicity of a paediatric dose (0.25 ml) and the standard dose (0.5 ml) of Epaxal® with reference to Havrix Junior® in healthy children and adolescents (more than or equal to 12 months to 16 years of age), using a 0/6 month schedule.

Study hypothesis The long term protection conferred by the pediatric dose of Epaxal® (12 IU) is comparable to that conferred by the standard dose of Epaxal® (24 IU).

Anticipated start date 01/12/2006
Anticipated end date 01/03/2011

www.controlled-trials.com/ISRCTN17386851
aossa
0
quote:

gocrucellgo schreef:

Krachtig spul dat Epaxal!!

A long-term follow up of a phase II open, randomised, controlled study to evaluate the safety and immunogenicity of a paediatric dose (0.25 ml) and the standard dose (0.5 ml) of Epaxal® with reference to Havrix Junior® in healthy children and adolescents (more than or equal to 12 months to 16 years of age), using a 0/6 month schedule.

Study hypothesis The long term protection conferred by the pediatric dose of Epaxal® (12 IU) is comparable to that conferred by the standard dose of Epaxal® (24 IU).

Anticipated start date 01/12/2006
Anticipated end date 01/03/2011

www.controlled-trials.com/ISRCTN17386851
Test van een paedriatic dose (0,25 ml) in vergelijking met een standaard dose (0,50 ml) nu toegepast bij kinderen van minimum 12 tot 16 maand oud. Men wil het vaccin gaan toepassen op jongere kinderen maar dan met een lagere dosis, logisch toch; gewoon een extensie van de toepassing.
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1
Geef mij maar Epaxal Dokter!

Travel Med Infect Dis. 2006 Dec

Rate, intensity, and duration of local reactions to a virosome-adjuvanted vs. an aluminium-adsorbed hepatitis A vaccine in UK travellers.

Paul D Clarke, Phillip Adams, Rubén Ibáñez, Christian Herzog

BACKGROUND: Travellers increasingly require hepatitis A virus (HAV) vaccine for overseas travel to highly endemic areas. While the inactivated HAV vaccines currently in use are all highly immunogenic, studies have shown the aluminium-free, virosome-adjuvanted vaccine Epaxal((R)) to possess a superior local tolerability profile. The objective of this study was to analyse the pattern of local reactions caused by the aluminium-free Epaxal((R)) compared with an aluminium-adjuvanted HAV vaccine. METHODS: Subjects recruited from travel health centres were randomised in a 4:1 ratio to receive a single dose of either Epaxal((R)) or Havrix((R)) vaccine. Vaccinees noted adverse reactions on a 7-day diary card that was returned by mail to the centre. RESULTS: 529 adults (16 years) were vaccinated, and 413 (78.1%) subjects returned diary cards, 338 (76.5%) in the Epaxal group and 75 (86.2%) in the Havrix group. Subjects reported fewer local adverse reactions for Epaxal (23.4% vs. 57.3%; p<0.0001). Injection site pain categorised as Grade 2 (painful on movement) or Grade 3 (spontaneously painful) (4.7% vs. 22.7%, p=0.0001) was less frequent in the Epaxal group and resolved more quickly (3 days of pain, 8.6% vs. 22.7%, p=0.0001). CONCLUSIONS: The lower reactogenicity of the virosome-adjuvanted vaccine is an important feature for travellers.
lib.bioinfo.pl/pmid:11433064
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Na Quinvaxem lijkt het me dat er een grote groei gaat aankomen voor Epaxal (Junior).
In Korea gaat de PR machine van start:

translate.google.com/translate?source...

Download: Campaign photos. Jpg


내 용 CONTENTS 대한소아청소년과개원의사회(회장 이청민)와 베르나바이오텍코리아㈜(대표이사 안상점)는 5월9일 가정의 달을 맞아 황금연휴기간 동안 동남아로 출국하는 여행객을 대상으로 인천국제공항에서 A형간염 질환에 대한 홍보캠페인을 벌였다. For youth and children's social gaewonui (yicheongmin chairman) and Bernardo bayiohtek Canada ㈜ (ansangjeom CEO) of the moon right at home on May 9 during the golden holidays in Southeast Asia as a destination for travelers departing from Incheon International Airport for the disease, hepatitis A Campaign to promote Middle East.

A형간염 질환은 미국,캐나다,유럽,일본 이외의 국가에서 주로 발생하는 전염병으로 동남아국가를자주 방문하는 우리나라 여행객들이 꼭 알아두어야 하는 질환이다. Hepatitis A disease in the United States, Canada, Europe, Japan, in a state of non-communicable diseases that occur primarily in the Southeast Asian countries have frequently visited our country travelers should be aware of the disease.

금번 A형간염질환 홍보 캠페인을 주관하는 대한소아청소년과개원의사회 민정혜 공보이사는 “최근 들어 A형 간염이 동남아국가들을 중심으로 많이 발생하고 있다는 사실은 대부분의 의사들이 공감하고 있는 사실” 이라며 “A형 간염은 오염된 식수, 어패류, 상한 우유 등의 음식을 섭취하였을 때 발생하기 때문에 위생환경이 좋지 않은 개발도상국에서 쉽게 걸리는 질환이다”고 설명했다. A publicity campaign, sponsored by hepatitis disease geumbeon for youth and children's social gaewonui minjeonghye director of publicity "Hepatitis A recent example is occurring in many Southeast Asian countries centered on the fact that most doctors will agree with the facts," "A Hepatitis is polluted drinking water, seafood, milk and other food intake may occur when the upper limit because of poor environmental sanitation in developing countries did not take the disease easily, "he said. 개발도상국 뿐만 아니라 우리나라에서도 특히 40대 이전 세대는 항체 보유율이 급격히 감소해 대부분 항체가 없는 상태이기 때문에 학교에서의 단체급식이나 군대 등의 단체생활을 하면서 A형 간염에 노출될 가능성이 높다. In Korea, 40, as well as developing countries, especially the older generation antibodies are antibodies retention is dramatically decreased in most schools because the state does not feed in groups or organizations, such as the military life, while exposed to hepatitis A is highly likely. 민정혜공보이사는 또 “어려서는 A형 간염에 걸리면 감기 정도로 지나가지만, 성인은 위장증상, 피곤감, 황달 등의 증세가 심해져 입원치료를 받아야 하는 경우가 많다”며,”심각한 간 손상을 일으킬 수 있는 A형 간염발병률이 해마다 늘어나고 있어서 질환에 대한 올바른 교육과 예방책이 절실하다”고 말했다. Hye, director of civil affairs, communications, "it takes longer for the flu, hepatitis A is young enough to miss, but the adult Symptoms of the stomach, pigongam, jaundice and other symptoms are often treated in hospital simhaejyeo", "can cause serious liver damage. Hepatitis A, which increases every year balbyeongryul disease so that appropriate precautions, and education is urgent, "he said.

이번 A형간염 질환 홍보캠페인을 기획한 베르나바이오텍코리아㈜ 마케팅 정영진PM은 간염환자 모임인 간사랑동우회가 발표한 설문조사 결과를 인용하면서 “전체825명을 대상으로한 설문에서 응답자의 18%만이 A형 간염의 감염경로나 전염성 여부에 대해 잘 알고 있는 것으로 나타났다며” “질환의 위험성에 비해 인지도가 낮은 &#
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위험성에 비해 인지도가 낮은 &# inderdaad..이번 A형간염 질환 홍보캠페인을 의 18%만이 A형 간염의 감염경로나 ” “질환의 위험성에 비해 인지도가 낮은 &# aanbeveling 이번 A형간염 질환 홍보캠페인을 기획한 베르나바이오텍코리아㈜ gr. ome Jo
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Virosomal Hepatitis A Vaccine: Comparing Intradermal and Subcutaneous With Intramuscular Administration

Authors: Frösner, Gert1; Steffen, Robert2; Herzog, Christian

Source: Journal of Travel Medicine, Volume 16, Number 6, November/December 2009 , pp. 413-419(7)

Publisher: Blackwell Publishing

Abstract:

Background.

Vaccination against hepatitis A virus (HAV) is unaffordable to many developing countries. Substantial reductions in cost occur when vaccines are administered intradermally at low doses. Aluminum-free HAV vaccines are considered more suitable for intradermal use than traditional vaccines which can cause long-lasting local reactions. Thus, we compared the immunogenicity and safety of an aluminum-free virosomal HAV vaccine (Epaxal®) administered by different routes: intradermal (i.d.), subcutaneous (s.c.), and intramuscular (i.m.). Methods.

The aluminum-free virosomal HAV vaccine Epaxal® is highly immunogenic and well tolerated when administered either via i.d., s.c., or i.m. Vaccination via the i.d. route may confer significant cost savings over the conventional i.m. route.

www.ingentaconnect.com/content/bpl/jt...
flosz
0
Reiziger wantrouwt vaccins
AMSTERDAM - In 2010 zal het aantal vakantievaccinaties afnemen doordat mensen minder ver op vakantie gaan, maar ook omdat ze de effecten van vaccinaties wantrouwen. Dat zegt Meditel, specialist in reizigersvaccininatie.
"Dat maakt de medische risico’s alleen maar groter”, zegt directeur van Meditel Jeroen van Luijk. Van Luijk spreekt zijn bezorgdheid uit op de vooravond van de Vakantiebeurs 2010.
"Vorig jaar ging de Nederlander minder ver op vliegvakantie. Niet naar Indonesië, maar naar Turkije. Niet naar Mexico, maar naar Kroatië. Dit maakt voor de medische risico’s niets uit.” Bovendien signaleert Meditel een vermindering in de bereidheid om gevaccineerd te worden.
De reisbureaus zien duidelijke trends: we reizen minder vaak én minder ver. Voor veel mensen is een vakantiebestemming als Kroatië of Turkije ‘lekker dichtbij’. Zij denken vaak dat vaccinaties voor deze landen niet nodig zijn. Want hoe kun je nu besmet raken in een vijfsterrenresort?
Van Luijk benadrukt dat besmetting niet van de sterren afhangt. "Hepatitis A bijvoorbeeld is heel makkelijk overdraagbaar via voedsel. Het personeel dat het eten klaarmaakt, is niet ingeënt. Het gevaar voor besmetting met hepatitis A is dus ook daar levensgroot.”
Behalve angst voor de prik speelt ook vrees voor bijwerkingen een rol. Zo doet op internet het gerucht de ronde dat je zieker wordt van de prik dan van de ziekte zelf. "Dat is natuurlijk onzin,” zegt Van Luijk, „maar we hebben duidelijk last van de commotie rond de vaccinaties tegen baarmoederhalskanker en Mexicaanse griep.”
www.telegraaf.nl/reiskrant/5757965/__...
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1
www.who.int/immunization_delivery/sys...

Summary table A: Ongoing/planned trials—licensed vaccines—immunocompetent subjects

Hepatitis A
Trial name,sponsor(s),collaborators,principal, investigators:
- Sponsors include:PharmaJet.

Status:
- At logistical planning stage.

Vaccine(s), vaccine types, devices used:
Vaccine: probably Epaxal (Berna/Crucell).

Country: Brazil.
flosz
2
Predicted 30-year protection after vaccination with an aluminum-free virosomal hepatitis A vaccine.

Bovier PA, Bock J, Ebengo TF, Frösner G, Glaus J, Herzog C, Loutan L.
Travel and Migration Medicine Unit, Department of Community Medicine, Geneva University Hospitals, Geneva, Switzerland.

Abstract
Few studies have examined the duration of protection following vaccination against hepatitis A virus (HAV) with currently licensed HAV vaccines. This study explored the long-term immunogenicity in individuals vaccinated with the virosomal hepatitis A virus, Epaxal. Adult volunteers (N = 130) previously enrolled into four different studies between 1992 and 1994 and who had completed a 0/12-month immunization regimen (primary and booster dose) were asked to participate in this follow-up study. Yearly anti-HAV titers up to 6 years following booster vaccination, and then once 9-11 years after booster were measured using two assays, Enzygnost and AxSYM HAVAB 2.0. Based on the Enzygnost assay, the seroprotection rate 9-11 years after booster was 100%, with a geometric mean concentration (GMC) of anti-HAV antibodies of 526 mIU/ml. Females had markedly higher GMCs than males (741 mIU/ml vs. 332 mIU/ml). Using an anti-HAV cut-off titer of >or=10 mIU/ml, a linear mixed mathematical model predicted a median duration of protection of 52.1 years. A duration of protection >or= 35.7 years was predicted for 95% of subjects. A more stringent cut-off of >or=20 mIU/ml shortened the median predicted duration of protection to 45.0 years. In conclusion, a two-dose Epaxal vaccination regimen confers in healthy adults a real-time protection of at least 9-11 years; this protection is predicted to last at least 30 years in over 95% of individuals. Further studies are necessary to assess the real duration of seroprotection and whether an additional booster is necessary later.
PMID: 20827757
www.ncbi.nlm.nih.gov/pubmed/20827757
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quote:

gocrucellgo schreef op 16 december 2006 21:27:

Krachtig spul dat Epaxal!!

A long-term follow up of a phase II open, randomised, controlled study to evaluate the safety and immunogenicity of a paediatric dose (0.25 ml) and the standard dose (0.5 ml) of Epaxal® with reference to Havrix Junior® in healthy children and adolescents (more than or equal to 12 months to 16 years of age), using a 0/6 month schedule.

Study hypothesis The long term protection conferred by the pediatric dose of Epaxal® (12 IU) is comparable to that conferred by the standard dose of Epaxal® (24U).

Anticipated start date 01/12/2006
Anticipated end date 01/03/2011

www.controlled-trials.com/ISRCTN17386851
Iemand al iets van de resultaten gezien ? Wil mijn kids komende week voor Hep-A laten vaccineren.

flosz
0
Hepatitis A Avaxim (2x nodig) € 46,50
Hepatitis A Vaqta Junior (2x nodig) € 32,50

Andere namen
Epaxal®
Havrix® 1440
Havrix® Junior
Hepatitis A Vaccin
Vaqta Junior®

Fabrikant/Leverancier
Sanofi Pasteur MSD
Euro Registratie Collectief B.V. (parallel import)
RVG 103530//20983

www.consumed.nl/medicijnen/233/Avaxim...
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