A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of Begrivac®, Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011 When Administered to Adult and Elderly Subjects

Annual trial for registration influenza vaccine Begrivac with strain composition for season 2010/2011.

Start Date01 Jun 2010

Sponsor / Collaborator-

NCT01032408 / CompletedPhase 3

A Phase 3, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Infection

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.
Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

Start Date01 Apr 2010

Sponsor / Collaborator

Chiltern-Pesquisa Clinica Ltda.

NCT01032395 / CompletedPhase 3

A Phase 3, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Chronic Pulmonary Disease, Chronic Heart Disease, or Diabetes Mellitus, and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.
Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

Start Date01 Mar 2010

Sponsor / Collaborator

Chiltern-Pesquisa Clinica Ltda.

100 Clinical Results associated with Influenza virus vaccine Begrivac ( CSL)

100 Translational Medicine associated with Influenza virus vaccine Begrivac ( CSL)

100 Patents (Medical) associated with Influenza virus vaccine Begrivac ( CSL)

Literatures (Medical) associated with Influenza virus vaccine Begrivac ( CSL)

01 Mar 2014·Iranian journal of medical sciences

Safety of a Trivalent Inactivated Influenza Vaccine in Health Care Workers in Kurdistan Province, Western Iran; A Longitudinal Follow-up Study.

Article

Author: Soltani, Jafar ; Jamil Amjadi, Mohamad

We studied the safety of a trivalent inactivated surface antigen (split virion, inactivated) influenza vaccine, Begrivac® (Novartis Company), widely used in health care workers in Kurdistan. A longitudinal follow-up study was performed in Sanandaj city, west of Iran, recruiting 936 people. A questionnaire was completed for each participant, and all symptoms or abnormal physical findings were recorded. In part 1 of the study, the post-vaccination complaints were headache (5.3%), fever (7.9%), weakness (9.6%), chills (10.1%), sweating (10.5%), arthralgia (20.2%), and malaise (21.5%). Swelling of the injection site was seen in 267 (30.3%) participants, and pruritus of the injection site was seen in 290 (32.9%) participants. Redness and induration were also reported in 42.5% of the participants. Local reactions were mainly mild and lasted for 1-2 days. No systemic reactions were reported in the second part of the study. None of the participants experienced any inconvenience. We concluded that local adverse reactions after the trivalent inactivated split influenza vaccine, Begrivac®, in health care workers were far more common than expected. Continuous surveillance is needed to assess the potential risks and benefits of newly produced influenza vaccines.

01 May 2013·Journal of Virological MethodsQ4 · MEDICINE

Improved high-throughput virus neutralisation assay for antibody estimation against pandemic and seasonal influenza strains from 2009 to 2011

Q4 · MEDICINE

Article

Author: Silvia Meier ; Martin Enders ; Elena Terletskaia-Ladwig

An automatable focus-reduction neutralisation test (AFRNT) for detecting influenza neutralising antibodies in serum was developed. The assay used immunoperoxidase staining and automated foci counting with AID Diagnostika ViruSpot software. Human serum samples (n=108) were collected before and after vaccination with Pandemrix or Begrivac and were tested by AFRNT and a haemagglutination inhibition assay (HI) using seasonal and pandemic influenza vaccine strains from 2009 to 2011. Much attention has been given to the factors that influence detection of neutralising titre, such as viral quantification and the use of receptor destroying enzyme (RDE) for serum treatment. Foci counting enabled precise virus quantification and the development of a highly sensitive assay. Pre-treatment of the human sera with RDE significantly reduced the neutralising titres against all strains, with the exception of the seasonal H1N1 (2009/2010) strain. An HI titre of 1:40, which is associated with a 50% clinical protection against influenza, was equivalent to an AFRNT titre of 1:100-1:200. In conclusion, the AFRNT is rapid, highly sensitive, and fully automatable; therefore, this test is perfectly suitable for the high-throughput detection of influenza-neutralising antibodies.

01 Dec 2004·Viral ImmunologyQ4 · MEDICINE

Antibody Response to Influenza Vaccination in Healthy Adults

Q4 · MEDICINE

Article

Author: Brydak, Lidia B. ; Magdalena, Machaka ; Tadeusz, Skwarczyński

The aim of this study was to assess antibody response in 184 healthy adults vaccinated with split influenza vaccine (Begrivac, Chiron Behring). Response to hemagglutinin and neuraminidase was assessed before vaccination and after 1 month by hemagglutination inhibition test and neuraminidase inhibition test. After vaccination, statistically significant increases of antibody titers, both for hemagglutinins and for neuraminidases, were observed. The post-vaccination proportion of persons with protective antihemagglutinin antibody titers ranged from 78.4%to 90.8%, while the proportion of persons with at least a fourfold increase of antihemagglutinin antibody titers ranged from 50.5% to 71.2%. All requirements of the Committee for Proprietary Medicinal Products regarding humoral response to inactivated influenza vaccine in healthy adults were fulfilled. Due to a wide range of age of the persons included in this study, the results were also analyzed in two age groups: from 20 to 45 years and from 46 to 56 years. Nevertheless, there were no statistically significant differences in antibody response between these two groups either for hemagglutinin or for neuraminidase.

100 Deals associated with Influenza virus vaccine Begrivac ( CSL)

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Indication	Country/Location	Organization	Date
Influenza, Human	DE	CSL Ltd.	16 Jul 1999

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