Delving into the Latest Updates on Seasonal influenza virus vaccine intradermal (sanofi pasteur) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

FluID, Fluzone ID, IDflu

+ [1]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication-

Originator Organization

Sanofi Pasteur SA

Active Organization

Sanofi Pasteur SA

Inactive Organization

Sanofi Pasteur EuropeSanofi KK

License Organization-

Drug Highest PhaseNDA/BLA

First Approval Date

European Union (24 Feb 2009),

Influenza, Human

Regulation-

Login to view timeline

The primary objectives of this study were:
To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than (<) 36 months of age and 3 to <9 years of age, and in adults 18 to <65 years of age; the immunogenicity of the 2018-2019 formulation of Flublok® Quadrivalent vaccine in adults 18 to <65 years of age; and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults greater than or equal to (>=) 65 years of age.
To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to <36 months of age and 3 to <9 years of age, and in adults 18 to <65 years of age; the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to <65 years of age; and the safety of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults >=65 years of age.

Start Date10 Sep 2018

Sponsor / Collaborator

Sanofi Pasteur SA

NCT03233217

/ CompletedPhase 1/2

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular or Subcutaneous Route in Participants Aged 65 Years and Older in Japan

This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to [>=] 65 years).

Start Date15 Sep 2017

Sponsor / Collaborator

Sanofi Pasteur SA

[+1]

NCT02960815

/ CompletedPhase 2IIT

Safety and Immunogenicity of Seasonal Influenza Vaccine With Topical Imiquimod in Immunocompromised Patients: A Randomized Controlled Pilot Trial

In this open label, single centre, pilot randomized controlled clinical trial the investigators aim to compare the immunogenicity and safety of a new influenza vaccination strategy consisting in the topical administration of imiquimod at the injection site before vaccination vs. a standard intramuscular vaccine injection in SOT recipients and HIV-infected individuals. The investigators planned to enroll 70 outpatients patients (50% solid-organ transplant recipients and 50% HIV-infected patients) regularly followed at the Transplantation center and the Infectious disease outpatients' clinics of the Lausanne University Hospital. Study participants will be randomized in a 1:1:1 ratio to receive the standard intramuscular vaccine (control group) or a topical application of an imiquimod containing cream followed by intramuscular (imiquimod-IM) or intradermal (imiquimod-ID) vaccine injection. After vaccination participants will be followed for a period of 180 days. Blood samples will be drawn at baseline and at day 21 and 180 for assessment of immunogenicity. Safety outcomes will be assessed immediately after vaccine administration, and at day 7 (phone call), 21 and 180.

Start Date01 Nov 2016

Sponsor / Collaborator

Centre Hospitalier Universitaire Vaudois

100 Clinical Results associated with Seasonal influenza virus vaccine intradermal (sanofi pasteur)

Login to view more data

100 Translational Medicine associated with Seasonal influenza virus vaccine intradermal (sanofi pasteur)

Login to view more data

100 Patents (Medical) associated with Seasonal influenza virus vaccine intradermal (sanofi pasteur)

Login to view more data

38

Literatures (Medical) associated with Seasonal influenza virus vaccine intradermal (sanofi pasteur)

02 Sep 2019·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season

Q3 · MEDICINE

Article

Author: Caroe, Timothy ; Gandhi-Banga, Sonja ; Butler, Karina ; Moureau, Annick ; Eymin, Cecile ; Chabanon, Anne-Laure

Safety surveillance is required for each season's influenza vaccines to rapidly detect and evaluate potential new safety concerns before the peak period of immunization. Here we report the results of an enhanced passive safety surveillance for a trivalent split-virion inactivated influenza vaccine (IIV3; Vaxigrip®), an intradermal version of this vaccine (IIV3-ID; Intanza® 15 µg), and a recently licensed quadrivalent version (IIV4; VaxigripTetra^TM) during the 2017/18 influenza season in the UK and Republic of Ireland. The primary objective was to determine the rates of adverse reactions (ARs) occurring within 7 days following routine vaccination. Between September and November 2017, 979 safety report cards were distributed to vaccinees receiving IIV3-ID, 1005 to those receiving IIV3, and 957 to those receiving IIV4. At least one AR was reported by 28 participants (2.9%) vaccinated with IIV3-ID, 14 participants (1.4%) vaccinated with IIV3, and 20 participants (2.1%) vaccinated with IIV4. The most frequent ARs were injection-site reactions and headache. One participant vaccinated with IIV3-ID reported two suspected serious ARs (dyskinesia and a shock symptom), although these could not be confirmed as vaccine-related. Rates of ARs for IIV3 and IIV3-ID for 2017/18 did not differ from the 2016/17 rates. For IIV4, in its first season since licensure, AR frequencies were similar to those in the Summary of Product Characteristics. In conclusion, no change was found compared to the known or expected AR rates for IIV3, IIV3-ID, or IIV4 during the 2017/18 season.

01 Sep 2019·Journal of acute medicine

A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference (SID) Fluid Versus Hartmann's Solution on Acid-Base Status in Sepsis Patients in the Emergency Department.

Article

Author: L Sappanie ; Sherene Tan Suann ; Aikhowe Teo ; Huahchiang Ooi ; Aidawati Bustam ; Abdul Muhaimin Noor Azhar ; Chunchiat Yeoh ; Sasi Kumar A ; Yingying Thum ; Rashidi Ahmad ; Kwanhathai Darin Wong

BACKGROUNDBalanced fluids are preferred in initial resuscitation of septic patients based on several recent studies. The Stewart's concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level. To date, the impact of high SID fluid in septic patient with metabolic acidosis remains uncertain. We conducted single center, randomized, double-blind trial to compare the effect of high SID fluid vs. Hartmann's solution on acid-base status in selected sepsis patients in the Emergency Department.METHODSSeptic patient with hyperlactatemia and metabolic acidosis were randomized to receive either high SID fl uid or Hartmann's solution during initial fl uid resuscitation. The primary outcome measures the pH and bicarbonate levels difference pre- and post- resuscitation.RESULTSOne hundred and sixty-two patients underwent randomization, 81 were assigned each to receive high SID fluid or Hartmann's solution. Both groups had similar baseline characteristics. High SID group received 23.5 mL/kg and the Hartmann's group received 22.7 mL/kg (p = 0.360). High SID fluid increased the mean (± SD) pH by 0.107 (± 0.09) vs. Hartmann's solution by 0.014 (± 0.12), p ≤ 0.001. Mean bicarbonate level increased signifi cantly in high SID group compared to Hartmann's (4.30 ± 3.76 vs. 1.25 ± 3.33, p ≤ 0.001). High SID group had higher post resuscitation lactate clearance than Hartmann's group (25.4 ± 28.3% vs. 12.0 ± 34.1%, p = 0.009). Shorter hospital stay was observed in highSID group 8.04 ± 5.96 days vs. Hartmann's group 12.18 ± 12.41 days (p = 0.048). Both groups showed no difference in incidence of pulmonary oedema, acute kidney injury and mortality.CONCLUSIONSInitial resuscitation using high SID fluid in selected septic patient improves pH and bicarbonate levels. The high SID group had better post resuscitation lactate clearance and shorter hospital stay.

01 Feb 2018·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season

Q3 · MEDICINE

Article

Author: Souverain, Audrey ; Caroe, Timothy David ; Ballandras, Céline ; Bricout, Hélène ; Butler, Karina M. ; Chabanon, Anne Laure

Passive enhanced safety surveillance (ESS) was implemented in the United Kingdom and in the Republic of Ireland for Vaxigrip and Intanza 15 µg influenza vaccines during the 2016/17 influenza season. Lessons learned during 2015/16 ESS implementation were integrated and applied towards the current ESS. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days of vaccination with Vaxigrip or Intanza 15 µg. For Vaxigrip (N = 962), 17 vaccinees (1.8%) reported 59 suspected ARs (6.1%) within 7 days of vaccination. For Intanza 15 µg (N = 1000), 21 vaccinees (2.1%) reported 101 (10.1%) suspected ARs within 7 days of vaccination. No obvious pattern in the type of suspected ARs or their frequency was observed for either vaccine. None of the frequencies of suspected ARs were above the 2015/16 ESS frequencies for Vaxigrip, whereas for Intanza 15 µg only one AR (oropharyngeal pain) crossed the historical threshold. There was no change in reactogenicity and data was consistent with the safety profiles of the two vaccines. The passive ESS experience gained from season to season will help to contribute to a sustainable safety surveillance system of seasonal influenza vaccines early in the season.

100 Deals associated with Seasonal influenza virus vaccine intradermal (sanofi pasteur)

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	Liechtenstein	Sanofi Pasteur SA	24 Feb 2009
Influenza, Human	Phase 3	European Union	Sanofi Pasteur Europe	24 Feb 2009
Influenza, Human	Phase 3	Liechtenstein	Sanofi Pasteur Europe	24 Feb 2009
Influenza, Human	Phase 3	European Union	Sanofi Pasteur SA	24 Feb 2009
Influenza, Human	Phase 3	Norway	Sanofi Pasteur Europe	24 Feb 2009

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03233217 (CTgov)	Phase 1/2	Influenza, Human	175	QIV-SD by SC (Cohort 2: QIV-SD by SC)	evplvrgsrp(cfdrcqqzer) = mveyfncglr xwqlwffoqm (uzxkpvxfaa, ahhazkqxhl - zzezinojpu) View more	-	17 Dec 2019
				QIV-HD by IM (Cohort 2: QIV-HD by IM)	uhcmjrlfko(ejarxuezvj) = uwyqdjacnq msdzinlklj (lbttvuhjdh, ungwsvjoar - ozxmonlhak) View more
NCT03617523 (GRC90, CTgov)	Phase 4	Influenza, Human	240	Fluzone Quadrivalent vaccine (Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months)	(lyxzjqkyjl) = bujsmrrzfi ngrwxpehhq (xtcqclmnti, ctahuugtqz - kqlhmkmsnc) View more	-	25 Nov 2019
				Fluzone Quadrivalent vaccine (Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years)	(ccmpnvcjkj) = vjxjraqfkz rypxhnbogt (xbrveusttk, beubogtclx - ipewjrwahu) View more
NCT02908269 (CTgov)	Phase 4	Influenza, Human	180	Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative (Fluzone Quadrivalent Vaccine Group 1: 3 to < 9 Years)	kdkyssrbeu(tfopohxayw) = liytucapzq jrxhaszccc (ceivlunyax, oxzomratpc - ikemqatowa) View more	-	08 Jan 2018
				Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative (Fluzone Quadrivalent Vaccine Group 2: 18 to < 65 Years)	xxtaeoyqpq(ziakokahco) = rignyhkjhg qvtuoqbzej (nthmlyrtrb, syhqtddfjb - xftjxligfj) View more
NCT01946438 (CTgov)	Phase 4	Influenza, Human	208	Influenza Virus Vaccine+Fluzone® Quadrivalent, (Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1))	(pbujgxsibt) = bvhmelxods qybhdtqyyc (xavjwksgso, vorznlqdpu - pumymkvyxu) View more	-	25 Sep 2014
				Influenza Virus Vaccine+Fluzone (Adult Fluzone® Intradermal, Influenza Vaccine (Group 2))	(pbujgxsibt) = hvmpcqgasl qybhdtqyyc (xavjwksgso, vcvbluvfnp - exsdnryoqf) View more
NCT01691339 (CTgov)	Phase 4	Influenza, Human	200	Influenza Virus Vaccine+Fluzone® 2012-2013 Formulation (Fluzone Vaccine (Group 1))	khyurgzklb(mttmcepami) = ozsxbkdwwe cfdpelueli (nigmmsxsjb, lmlxxghuyt - karqytexha) View more	-	03 Nov 2013
				Influenza Virus Vaccine+Fluzone® (Fluzone Intradermal Vaccine (Group 2))	khyurgzklb(mttmcepami) = vvkpcutmbl cfdpelueli (nigmmsxsjb, bdeidziqbd - fqpjybpyjw) View more
NCT00390884 (CTgov)	Phase 4	Influenza, Human	173	Influenza Virus Vaccine+Fluzone (Fluzone®-Primed Group)	umpoenohta(sxuqdadizy) = gwwhnksoqu wbbtrtvgtn (jjvmvqthdn, ffukdpalxz - sygogkmfpe) View more	-	31 Dec 2009
				Influenza Virus Vaccine+Fluzone (Fluzone®-Naive Group)	umpoenohta(sxuqdadizy) = hxfhsdxteu wbbtrtvgtn (jjvmvqthdn, pgwazsjegm - quxhtfjhwj) View more
NCT00831987 (CTgov)	Phase 4	Influenza, Human	120	Influenza virus vaccine 2004-2005 formulation+Fluzone® (Fluzone® Vaccine Group - Age 18-59 Years)	etfystixsu(doptppbbac) = frcwilowoq nfritingdn (apbitmjuud, uemvatfghn - dchbecdrub) View more	-	27 Aug 2009
				Influenza virus vaccine 2004-2005 formulation+Fluzone® (Fluzone® Vaccine Group - Age ≥ 60 Years)	etfystixsu(doptppbbac) = txwafittcg nfritingdn (apbitmjuud, gqycrimygb - idrfcindot) View more
NCT00389857 (CTgov)	Phase 4	Influenza, Human	31	Influenza Virus Vaccine+Fluzone (Influenza Vaccine-Naive Group)	pqquicykbk(gttpetevyy) = hwlkbfhhzj bwgekabvfq (cuhofobvvq, fviqwghius - uaowdfiavs) View more	-	24 Mar 2009
				Influenza Virus Vaccine+Fluzone (Influenza Vaccine-Primed Group)	pqquicykbk(gttpetevyy) = renhzrukac bwgekabvfq (cuhofobvvq, vzcgcvostu - rupgfhdmmj) View more