Navigation Links
FDA Approves KINRIX(TM) - New Combination Vaccine for Children
Date:6/24/2008

- New option could mean fewer shots for 4 to 6 year-olds in the U.S. -

PHILADELPHIA, June 24 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved KINRIX(TM) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], the first combination vaccine to offer protection against diphtheria, tetanus, pertussis and polio diseases in one shot.

"Children 4 to 6 years-old can receive five or more vaccinations in a single visit, which can be stressful for parents and vaccinators," said William P. Hitchcock, MD, Assistant Clinical Professor of Pediatrics, University of California, San Diego School of Medicine. "By reducing the number of shots given in one visit, combination vaccines like KINRIX may make it easier for kids to meet school vaccination requirements and CDC recommendations."

Clinical studies of KINRIX have demonstrated that this new combination vaccine offers similar protection to the separately administered Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) and Inactivated Poliovirus (IPV) vaccines, with a comparable safety profile. These results were confirmed in the pivotal Phase III trial of KINRIX, which was a randomized, controlled study conducted in the U.S. in which 3,156 children 4 to 6 years of age were vaccinated with KINRIX. All children studied had previously received four doses of DTaP (INFANRIX(R)) and three doses of IPV (IPOL(R)). All children in the study also received the second dose of U.S.-licensed measles, mumps and rubella (MMR) vaccine (M-M-RII(R)) at the same time.

"KINRIX contains the same DTaP and IPV components used in INFANRIX and PEDIARIX(R), two vaccines which have been used by doctors in the U.S. for many years," said Wayde M. Weston, Ph.D., Director, U.S. Clinical Research and Development/Medical Affairs, GlaxoSmithKline. "With the introduction of KINRIX, eligible 4 to 6 year-olds can receive protection against four serious diseases with one less shot."

About KINRIX and Combination Vaccines

KINRIX is approved for children 4 to 6 years of age whose previous Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccinations have been with PEDIARIX(R) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] and/or INFANRIX(R) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed].

Health experts recommend combination vaccines to reduce the number of shots children receive in a single doctor visit. In fact, combination vaccines, such as DTP [diphtheria, tetanus and pertussis], have been available and effectively used for almost 60 years. KINRIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], manufactured by GlaxoSmithKline, is the latest combination vaccine.

Important Safety Information

In clinical studies, common adverse events were injection-site reactions (pain, redness, swelling, or increase in arm circumference), drowsiness, fever, and loss of appetite. Previous hypersensitivity to any component of KINRIX, including neomycin and polymyxin B, is a contraindication. Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. The decision to give KINRIX should be based on potential benefits and risks, if Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events have occurred in temporal relation to receipt of a pertussis-containing vaccine. The needleless, prefilled syringes contain dry natural latex rubber and may cause allergic reactions. For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination. Vaccination with KINRIX may not protect all individuals who received the vaccine. More information on KINRIX is available at http://www.kinrix.com.

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world -- an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world's children from up to six diseases in one vaccine.

KINRIX, INFANRIX, and PEDIARIX are all trademarks of the GlaxoSmithKline group of companies.

IPOL is a registered trademark of Sanofi Pasteur, the vaccines business of sanofi-aventis Group.
M-M-RII is a registered trademark of Merck & Co., Inc.

Inquiries:

US Media Inquiries Jennifer Armstrong +1 919 483 2839

Liad Diamond


'/>"/>
SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. FDA Approves VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma
2. Japan Approves CyberKnife System for Extracranial Use
3. FDA approves NeuRx diaphragm pacing system for use in spinal cord- injured patients
4. FDA Approves Cymbalta(R) for the Management of Fibromyalgia
5. ClearWay Minnesota(SM) Board Approves $1.4 Million in New Grants to Reduce Tobaccos Harm
6. FDA Approves AstraZenecas Seroquel(R) for Maintenance Treatment in Bipolar Disorder
7. FDA Approves NOVO NORDISKs NovoSeven(R) RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors
8. FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
9. FDA Approves Health Claim for Brown Rice
10. FDA Approves Strattera(R) for Maintenance of ADHD in Children and Adolescents
11. FDA approves HeartMate II mechanical heart pump for heart-failure patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... , ... March 24, 2017 , ... ... which will spark a conversation on the current obstacles facing infection prevention and ... completely preventable deaths caused by these infections. , The print component of ...
(Date:3/24/2017)... ... 24, 2017 , ... Digital Scientists, a software innovation lab specializing in web ... Greenville, South Carolina location. The lab has set up shop at the ... working with South Carolina clients for years from our office here in Atlanta,” explains ...
(Date:3/24/2017)... ... March 24, 2017 , ... According to a new study ... because it does not obey the rules Congress has directed the CBO to follow. ... the GOP reform would restore. Yet, it estimates a reduction in employer-based coverage due ...
(Date:3/24/2017)... ... ... The iaedp Foundation, the premier provider of educational programs and training standards for ... spectrum of disordered eating, announced today that the 2017 Symposium set a new attendance ... several countries converged on the Green Valley Resort in Las Vegas. , “We ...
(Date:3/24/2017)... ... 2017 , ... Shamanic healer and teacher Anahata Ananda of ... Awakening, proudly presents her Sacred Peru retreat with world famous shaman and ... during the Summer Solstice will also be her final international retreat, Anahata announced ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)...  Eli Lilly and Company (NYSE: ... million in its U.S. operations in 2017. The ... including research laboratories, manufacturing sites, and general and ... demand for Lilly products, as well as its ... cancer, pain, diabetes and other unmet medical needs.  ...
(Date:3/24/2017)... 23, 2017  Mirabilis Medical, a ... for non-invasive surgery, announced today CE Mark authorization ... of uterine fibroids throughout the European Union.  The ... from the US Food and Drug Administration to ... in the United States.  The Mirabilis System combines ...
(Date:3/24/2017)... and GENEVA , March ... on World Tuberculosis Day revitalizes efforts to develop sutezolid ... On World Tuberculosis Day, TB Alliance and the ... the clinical development of sutezolid, an antibiotic drug candidate ... pertains to the development of sutezolid in combination with ...
Breaking Medicine Technology: