FLULAVAL SUMMARY
FLULAVAL, Influenza Virus Vaccine, for intramuscular injection, is a trivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens eggs. Each of the influenza virus strains is produced and purified separately. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate.
FLULAVAL� is indicated for active immunization of adults (18 years of age and older) against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
This indication is based on immune response elicited by FLULAVAL, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with FLULAVAL [see Clinical Studies].
|
NEWS HIGHLIGHTS
Published Studies Related to Flulaval (Influenza Virus Vaccine)
Preflucel®: a Vero-cell culture-derived trivalent influenza vaccine. [2012]
Vaccination is the principal means to reduce the impact of influenza infection...
Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived
influenza vaccine in healthy children and adolescents three to seventeen years of
age. [2012]
vaccine (TIV) in a healthy pediatric population... CONCLUSION: CCIV produced in mammalian cell culture is a safe, well-tolerated and
A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. [2011.11.08]
CONCLUSIONS: Adjuvant systems can be safely used in influenza vaccines, including the adjuvant monophosphoryl lipid A (MPL) derived from Bordetella pertussis with squalene and aluminum hydroxide, MPL with aluminum hydroxide, and squalene and aluminum hydroxide. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Oil-in-water emulsion adjuvant with influenza vaccine in young children. [2011.10.13]
BACKGROUND: The efficacy of inactivated influenza vaccines is known to be poor in infants and young children... CONCLUSIONS: Influenza vaccine with the MF59 adjuvant is efficacious against PCR-confirmed influenza in infants and young children. (Funded by Novartis Vaccines and Diagnostics; ClinicalTrials.gov number, NCT00644059.).
Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok(R)) against influenza in healthy adults: a randomized, placebo-controlled trial. [2011.10.13]
BACKGROUND: Development of influenza vaccines that do not use embryonated eggs as the substrate for vaccine production is a high priority. We conducted this study to determine the protective efficacy a recombinant, baculovirus-expressed seasonal trivalent influenza virus hemagglutinin (rHA0) vaccine (FluBlok((R)))... CONCLUSIONS: Trivalent rHA0 vaccine was safe, immunogenic and effective in the prevention of culture confirmed influenza illness, including protection against drift variants. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Clinical Trials Related to Flulaval (Influenza Virus Vaccine)
Immunogenicity and Safety of Live Attenuated Influenza Vaccine (Flumist) Administered by Nasal and Sublingual Route [Recruiting]
Background: It is well established that live attenuated organisms can be highly effective
vaccines, immune responses elicited can often be of greater magnitude and of longer duration
than those produced by non-living antigens and are often able to confer protection after a
single dose. Unlike killed influenza vaccine preparations injected by the parenteral route,
live influenza vaccines are able to induce potent secretory (mainly IgA) antibody responses
in the airway mucosae and can also evoke cell mediated responses. T cell proliferation,
cytokine production, cytotoxic T cell responses and antibody-dependent cell cytotoxicity
have all been elicited by live attenuated vaccines.
There has been a history of the use of live attenuated flu vaccines as safe and effective
vaccines for the prevention of flu in animals and humans. Live-attenuated cold-adapted
influenza vaccines have been proved to be highly efficacious to protect against clinical fly
symptoms. Among these, FluMist, a nasal vaccine formulation developed by Medimmune Inc, has
been approved by the US FDA. Recent side by side clinical trials have demonstrated that this
nasal vaccine was significantly superior to conventional killed flu vaccine in protecting
against flu symptoms.
Sublingual administration of live influenza virus at a dose lethal by the nasal route was
well tolerated and did not redirect virus to the olfactory bulb. In addition, in a recent
Phase I clinical study (NCT00820144) conducted in France, the sublingual administration of
rCTB (up to 1 mg) in healthy adult volunteers was found to be safe.
A major issue has arisen regarding the ease with which vaccines could be administered to
young children, especially infants, and to elderly subjects in whom nasal vaccination has
not been possible and/or approved due to difficulties of administering nasal vaccines in
infants and to undesired side effects related to frequent rhinitis and sneezing episodes in
elderly subjects. This study is designed to investigate the safety, tolerability and
immunogenicity of a new route of administration of vaccines, using the nasal FluMist
formulation as prototype vaccine.
Objectives: To evaluate the immunogenicity and safety of a nasal and sublingual influenza
virus vaccine (FluMist) in healthy adult volunteers
Study design: This will be a randomized study on a total 40 subjects; each 20 subjects will
receive vaccine via nasal and sublingual route, respectively
A Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and Seasonal Influenza Vaccine [Recruiting]
This is a single blinded placebo controlled phase I study, to assess the safety and
immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with
seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over.
The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV)
is that the immune system will be stimulated to produce both influenza specific T cells and
influenza specific antibodies.
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV [Recruiting]
This is a open label-study of Fluzone HD, a high-dose form of trivalent, inactivated
influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or
HIV will be vaccinated twice with one of the two vaccines and evaluated for development of
immune responses.
Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age [Recruiting]
Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients [Recruiting]
Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant
(SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not
be significantly different from adult stem cell transplant recipients receiving standard
dose (SD) TIV.
- Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza
vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic
stem cell transplant recipients.
Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent
influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody
titers to influenza antigens compared to those who receive standard dose trivalent influenza
vaccine.
- Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell
transplant recipients influenza virus antigens included in trivalent influenza vaccine
after high dose or standard dose trivalent influenza vaccine.
|
