4 results on '"Girard MP"'
Search Results
2. Report of the 7th meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials, World Health Organization, Geneva, 17-18 February 2011.
- Author
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Girard MP, Katz JM, Pervikov Y, Hombach J, and Tam JS
- Subjects
- Adjuvants, Immunologic administration & dosage, Adolescent, Adult, Aged, Aged, 80 and over, Biotechnology methods, Child, Child, Preschool, Clinical Trials as Topic, Female, Humans, Infant, Infant, Newborn, Influenza Vaccines adverse effects, Influenza, Human virology, Male, Middle Aged, Pregnancy, Technology, Pharmaceutical methods, Treatment Outcome, Vaccines, Attenuated administration & dosage, Vaccines, Attenuated adverse effects, Vaccines, Attenuated immunology, Vaccines, Inactivated administration & dosage, Vaccines, Inactivated adverse effects, Vaccines, Inactivated immunology, World Health Organization, Young Adult, Influenza A Virus, H1N1 Subtype immunology, Influenza Vaccines administration & dosage, Influenza Vaccines immunology, Influenza, Human prevention & control, Vaccination methods
- Abstract
On February 17-18, 2011, the World Health Organization convened the 7th meeting on "The Evaluation of Pandemic Influenza Vaccines in Clinical Trials" to review the progress made on pandemic A (H1N1) 2009 vaccines and the evaluation of their effectiveness in the field, especially in children less than 3 years of age and in pregnant women. Other topics to be addressed included a comparison of egg- and cell culture-based influenza vaccines, technical issues related to vaccine strain development and vaccine potency, and the status of development of prototype influenza vaccines using new technologies. Pandemic A (H1N1) vaccines were safe in young children, pregnant women and immunocompromized individuals. Overall effectiveness of inactivated A (H1N1) vaccines for all ages was found to vary between 72% and 100% in different countries and with different vaccine preparations. Effectiveness of pandemic A (H1N1) 2009 live attenuated vaccine was estimated to be approximately 80% in pediatric populations in the USA. A single dose of inactivated vaccine adjuvanted with AS03, MF59 or AF03 induced protective immunity in young children and pregnant women. However, unadjuvanted vaccines as well as low dose adjuvanted vaccines (1.9 μg HA) required two doses to elicit protective antibody levels in these populations. Clinical trials of influenza vaccines developed using new technologies showed they were well tolerated and induced antibody and/or T cell immune responses to viral proteins. Further studies are warranted to validate novel immunological criteria for evaluation and licensing of such new influenza vaccine concepts. On the regulatory side, work should be undertaken to harmonize the results of serological tests used to evaluate the immunogenicity of traditional influenza vaccines., (Copyright © 2011. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2011
- Full Text
- View/download PDF
3. Report of the 6th meeting on the evaluation of pandemic influenza vaccines in clinical trials World Health Organization, Geneva, Switzerland, 17-18 February 2010.
- Author
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Girard MP, Katz J, Pervikov Y, Palkonyay L, and Kieny MP
- Subjects
- Antibodies, Viral blood, Child, Child, Preschool, Congresses as Topic, Humans, Infant, Influenza A Virus, H1N1 Subtype, Influenza A Virus, H5N1 Subtype, Influenza Vaccines standards, Pandemics prevention & control, Vaccines, Attenuated immunology, Vaccines, Attenuated standards, Vaccines, Inactivated immunology, Vaccines, Inactivated standards, World Health Organization, Influenza Vaccines immunology, Influenza, Human prevention & control
- Abstract
On February 17-18, 2010, the World Health Organization (WHO) convened the 6th meeting on the "Evaluation of pandemic influenza vaccines in clinical trials" to review the progress made on new A (H1N1) 2009 vaccines and prototype H5N1 vaccines and their evaluation in clinical trials. A number of vaccine types were reviewed, including classical egg-derived and cell culture-derived inactivated vaccines, such as split virus or whole-virion vaccines, and live-attenuated vaccines (LAIV), as well as vaccines developed using new technologies. The amount of antigen needed, the effect of adjuvants and the number of doses required to induce adequate antibody responses in various populations, together with the issue of safety of the vaccines, were major topics of the meeting. The effectiveness of H1N1 vaccines and the need for standardization of vaccine potency tests were also discussed. Independent of the vaccine type and the presence or absence of an adjuvant, all A (H1N1) 2009 vaccines were well tolerated, eliciting only mild to moderate local or systemic reactions. For most vaccines tested, a single dose was sufficient to elicit a potentially protective antibody response in the majority of vaccinees >10 years of age. However, a second dose of vaccine was needed to boost immune responses in infants and toddlers 6 months to 3 years of age and, with some vaccines, in children aged 3-9 years., (Copyright © 2010 World Health Organization. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2010
- Full Text
- View/download PDF
4. The 2009 A (H1N1) influenza virus pandemic: A review.
- Author
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Girard MP, Tam JS, Assossou OM, and Kieny MP
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Animals, Antiviral Agents pharmacology, Child, Child, Preschool, Cost of Illness, Female, Humans, Infant, Influenza, Human prevention & control, Influenza, Human transmission, Influenza, Human virology, Middle Aged, Pregnancy, Risk Factors, Swine, Young Adult, Disease Outbreaks, Influenza A Virus, H1N1 Subtype drug effects, Influenza A Virus, H1N1 Subtype genetics, Influenza A Virus, H1N1 Subtype immunology, Influenza Vaccines immunology, Influenza, Human epidemiology
- Abstract
In March and early April 2009 a new swine-origin influenza virus (S-OIV), A (H1N1), emerged in Mexico and the USA. The virus quickly spread worldwide through human-to-human transmission. In view of the number of countries and communities which were reporting human cases, the World Health Organization raised the influenza pandemic alert to the highest level (level 6) on June 11, 2009. The propensity of the virus to primarily affect children, young adults and pregnant women, especially those with an underlying lung or cardiac disease condition, and the substantial increase in rate of hospitalizations, prompted the efforts of the pharmaceutical industry, including new manufacturers from China, Thailand, India and South America, to develop pandemic H1N1 influenza vaccines. All currently registered vaccines were tested for safety and immunogenicity in clinical trials on human volunteers. All were found to be safe and to elicit potentially protective antibody responses after the administration of a single dose of vaccine, including split inactivated vaccines with or without adjuvant, whole-virion vaccines and live-attenuated vaccines. The need for an increased surveillance of influenza virus circulation in swine is outlined., (Copyright 2010. Published by Elsevier Ltd.)
- Published
- 2010
- Full Text
- View/download PDF
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