GlaxoSmithKline's Havrix now approved for use in children aged 12 months and older

Philadelphia, PA October 18, 2005 GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) approved the expanded use of Havrix(R) (hepatitis A vaccine, inactivated) for the prevention of hepatitis A in children aged 12 months and older. Havrix was previously approved by the FDA for use in children ages two through 18 years. This expanded indication will allow healthcare practitioners to vaccinate younger children against hepatitis A with Havrix and may help to further reduce the incidence of hepatitis A in the United States, particularly among young children who often transmit the disease.

"The expanded indication of Havrix marks an important milestone in the fight against hepatitis A in the United States," said William P. Hitchcock, M.D., of the American Board of Pediatrics, La Jolla, California. "Immunizing children under age two helps protect a very vulnerable population that often does not show symptoms of the disease but frequently spreads it to other children and family members."

Havrix for the Prevention of Hepatitis A in Children Aged 12 Months and Older
The FDA approved the expanded use of Havrix in children to 12 months and older on the basis of a pivotal trial which studied the administration of Havrix in children in the United States and Australia. The prospective, open, comparative, multi-center clinical trial involved over 1,000 healthy children and showed Havrix given to children down to the age of 11 months to be comparable to Havrix given to children approximately two years of age with regard to safety and immunogenicity. The study also showed that Havrix can be given concomitantly with OMNIHIBTM [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)], also called Hib conjugate vaccine (PRP-T).

Each subject was enrolled in one of five groups according to their age and previous vaccination history and vaccinated with either Havrix alone or Havrix with Infanrix (D


Page: 1 2 3

Related medicine news :

1. Did drug reps encourage doctors to prescribe gabapentin for nonapproved uses?
2. NIH scientists honored for FDA-approved cervical cancer vaccine breakthrough
3. Previously approved drugs may be helpful in fatal pediatric disorder
4. Shires DAYTRANA(TM) transdermal patch approved by FDA for treatment of ADHD
5. Higher dose formulation of FOSRENOL approved to reduce serum phosphorus in esrd patients
6. FDA approved ROZEREM (ramelteon)
7. Cedars-Sinais live donor liver transplant program receives unos-approved designation
8. Many drugs prescribed for chronic insomnia are not approved for that purpose
9. Sildenafil (Viagra) approved for treatment of pulmonary arterial hypertension (PAH) as Revatio
10. Chinese children with hearing devices benefit from new speech test
11. Seat belt injuries could signal more serious trauma in children

Post Your Comments:

(Date:11/27/2015)... CO (PRWEB) , ... November 27, 2015 , ... According ... cities are not changing the way that they are handling security in light of ... police and security presence in an attempt to stop an attack from reaching U.S. ...
(Date:11/27/2015)... County, CA (PRWEB) , ... November 27, 2015 , ... ... season , The company is offering customers 10% off of their purchase of lice ... any treatment at full price. According to a company spokesperson. “Finding lice is a ...
(Date:11/27/2015)... ... November 27, 2015 , ... Intellitec ... Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group for end users ... Dynamics SL software users, partners, industry experts and representatives. Intellitec Solutions’ membership status ...
(Date:11/27/2015)... IL (PRWEB) , ... November 27, 2015 , ... ... of the largest, most successful and prominent nonprofit healthcare organizations in the country. ... governance involvement with various organizations, and helped advance the healthcare industry as a ...
(Date:11/26/2015)... ... ... Inevitably when people think Thanksgiving, they also think Holiday sales and start ... and Cyber Monday massage chair sales to receive the best pricing on ... find the best massage chair deals, they can see all of the coupons in ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... --> RnRMarketResearch.com adds "Global ... and "Investigation Report on China Repaglinide ... 2021 forecasts data and information to ... http://www.rnrmarketresearch.com/global-repaglinide-industry-2015-market-research-report-market-report.html . --> ...
(Date:11/26/2015)... 26, 2015 http://www.researchandmarkets.com/research/plc28h/radioimmunoassay ... "Radioimmunoassay Market by Type (Reagents & ... Academics, Clinical Diagnostic Labs), Application (Research, Clinical ... 2020" report to their offering. ... addition of the "Radioimmunoassay Market by ...
(Date:11/25/2015)...  The total global healthcare industry is expected to grow ... Latin America has the highest projected growth at ... Japan ), is second with growth projected at 11.5%. ... healthcare expenditure. In 2013-2014, total government funded healthcare was nearly ... to 41.2% in 2013-2014. In real terms, out of pocket ...
Breaking Medicine Technology:
Cached News: