A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Egg-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects From 6 Months to 17 Years of Age

The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.

开始日期2009-09-01

申办/合作机构-

NCT00971906 / Completed临床3期

A Randomized, Single-blind, Dose-Ranging, Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects 18 or More Years of Age

This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.

开始日期2009-08-01

申办/合作机构-

NCT00992212 / Completed临床2期

A Phase II, Open Label Study to Evaluate the Immunogenicity, Tolerability and Safety of an Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 Years and Above

This present study, a phase II, open label study will evaluate the immunogenicity, tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in healthy subjects aged 18 years and above. This study will explore the effect of the previous and concomitant exposure to a seasonal influenza vaccination to the immunogenicity and safety profile of two different doses of an adjuvanted H1N1sw vaccine.

开始日期2009-08-01

申办/合作机构-

100 项与 Influenza A vaccine H1N1(Zydus Cadila Healthcare Ltd.) 相关的临床结果

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100 项与 Influenza A vaccine H1N1(Zydus Cadila Healthcare Ltd.) 相关的专利（医药）

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项与 Influenza A vaccine H1N1(Zydus Cadila Healthcare Ltd.) 相关的文献（医药）

2013-01-01·Maternal and Child Health Journal3区 · 医学

Determinants of 2009 A/H1N1 Influenza Vaccination Among Pregnant Women in Hong Kong

3区 · 医学

Article

作者: Carol Yuet Sheung Yuen ; Marie Tarrant ; Vincci Hiu Sze Chan ; Ka Lun Cheung ; Kendra M. Wu

During the 2009–2010 A/H1N1 influenza pandemic, pregnant women infected with the virus experienced excess morbidity and mortality when compared with other groups. Once a vaccine was available, pregnant women were a priority group for vaccination. Only a few studies have reported on the uptake of 2009 A/H1N1 influenza vaccine among pregnant women during the pandemic and none were from Asia. The purpose of this study was to examine factors associated with 2009 A/H1N1 influenza vaccine uptake among pregnant women in Hong Kong. Using a multi-center, cross-sectional design, we recruited 549 postpartum women from four post-natal wards in Hong Kong over a 4-month period during the second wave of the A/H1N1 influenza pandemic in the winter and spring of 2010. Only 6.2% (n = 34) of participants had received the 2009 A/H1N1 influenza vaccine and 4.9% (n = 27) had received the seasonal influenza vaccine. The most common reasons for not receiving the 2009 A/H1N1 vaccine were fear of causing harm to themselves or their fetus. A high knowledge level (OR = 19.06; 95% CI 5.55, 65.48), more positive attitudes (OR = 3.52; 95% CI 1.37, 9.07), and having a family member who had the 2009 A/H1N1 influenza vaccine (OR = 7.69; 95% CI 2.92, 20.19) were independently and positively associated with vaccination. Study results show an unacceptably low uptake of the pandemic A/H1N1 influenza vaccine among pregnant women in Hong Kong. Interventions to increase influenza vaccine knowledge and uptake among this group should be a priority for future pandemic planning and seasonal vaccination campaigns.

2012-11-01·Vaccine3区 · 医学

Autoimmune disorders after immunisation with Influenza A/H1N1 vaccines with and without adjuvant: EudraVigilance data and literature review

3区 · 医学

Review

作者: Steven Le Meur ; Xavier Kurz ; Ana Hidalgo-Simon ; Alina Isai ; Julie Durand

All suspected autoimmune disorders (AID) reported as adverse reactions to EudraVigilance from 1 October 2009 to 31 December 2010 for adjuvanted (Celtura™, Fluval P™, Focetria™ and Pandemrix™) and non-adjuvanted (Cantgrip™, Celvapan™ and Panenza™) pandemic Influenza A/H1N1 vaccines were analysed to determine whether adjuvanted vaccines were associated with higher reporting of AID than non-adjuvanted ones. AID were identified based on the corresponding MedDRA High Level Group Term. Reports of type 1 diabetes mellitus and multiple sclerosis were also included in the analysis. Causality was assessed based on WHO causality assessment for adverse events following immunisation and Brighton Collaboration criteria for Guillain-Barré syndrome (GBS), idiopathic thrombocytopenic purpura and acute disseminated encephalomyelitis. Of the 50,221 adverse reactions received in EudraVigilance for A/H1N1 vaccines (adjuvanted: 46,173, non-adjuvanted: 4048), 314 were AID (adjuvanted: 276, non-adjuvanted: 38). GBS was the AID with the highest number of reports (125, adjuvanted: 109, non-adjuvanted: 16). Reporting ratios as calculated by the percentages of AID amongst all reported adverse reactions were 0.60% (95% CI: 0.53-0.67) and 0.94% (95% CI: 0.64-1.24) for adjuvanted and non-adjuvanted vaccines, and were 0.26% (95% CI: 0.22-0.31) and 0.37% (95% CI: 0.18-0.56) in a restricted analysis based on diagnostic certainty, causal relationship and plausible temporal association. Reporting rates for all reports of AID using the estimated number of vaccinees as denominator were 6.87 (95% CI: 6.06-7.68) and 9.98 (95% CI: 6.81-13.16) per million for adjuvanted and non-adjuvanted vaccines, and 3.01 (95% CI: 2.47-3.55) and 3.94 (95% CI: 1.95-5.94) per million in the restricted analysis. These results do not suggest a difference in the reporting of AID between adjuvanted and non-adjuvanted A/H1N1 vaccines. In a literature review performed on 31 August 2011, GBS was also the AID the most frequently discussed in association with A/H1N1 vaccination; reporting rates were generally within expected background rates.

2012-10-17·Influenza Research and Treatment

Factors Affecting Acceptance and Intention to Receive Pandemic Influenza A H1N1 Vaccine among Primary School Children: A Cross-Sectional Study in Birmingham, UK

Article

作者: Jordan, Rachel E. ; Cooke, Sara ; Janks, Michaela ; Bellman, Michelle ; Kang, Harkeet ; Odedra, Aimee

UK pandemic influenza strategy focused on vaccination of high risk groups, although evidence shows that school-age children have the highest infection rates. Vaccination of children might be an additional strategy. We undertook a cross-sectional study amongst 149 parents of primary school children aged 4–7 years in Birmingham, UK to quantify intention to accept pandemic influenza vaccine and identify factors affecting uptake. Ninety-one (61.1%, 95% CI 52.8, 68.9) had or would accept vaccine for their child. The most common reasons for declining vaccine were concerns about safety (58.6% reported this), side effects (55.2%), or believing their child had already had swine flu (12.1%). Parents of nonwhite ethnicity (OR 2.4 (1.1, 5.0)) and with asthmatic children (OR 6.6 (1.4, 32.1)) were significantly more likely to accept pandemic vaccine, as were those whose children had ever received seasonal vaccine and those who believed swine flu to be a serious threat (OR 4.2 (1.9, 9.1)). Parents would be more likely to accept vaccination if they received a letter of invite, if the government strongly encouraged them, if it were administered at school, and if it were more thoroughly tested. Accurate media portrayal of safety of the vaccine during future pandemics will be essential.

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