当前位置： SCI文献检索 > VACCINE期刊下所有文献 > Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial.

Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial.

Abstract：

BACKGROUND:Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate. METHODS:This phase III, randomized, controlled, multicenter trial in children/adolescents (9 through 17 years) and adults (18 through 60 years) was conducted in Australia and in the Philippines in 2012. The study was double-blind for IIV4 lots and open-label for IIV4 vs IIV3. Children/adolescents were randomized 2:2:2:1 and adults 10:10:10:1 to receive one of three lots of IIV4 or licensed IIV3. Safety data were collected for up to 6 months post-vaccination. Hemagglutination inhibition and seroneutralization antibody titers were assessed pre-vaccination and 21 days post-vaccination. RESULTS:1648 adults and 329 children/adolescents received IIV4, and 56 adults and 55 children/adolescents received IIV3. Solicited reactions, unsolicited adverse events, and serious adverse events were similar for IIV3 and IIV4 recipients in both age groups. Injection-site pain, headache, malaise, and myalgia were the most frequently reported solicited reactions, most of which were mild and resolved within 3 days. No vaccine-related serious adverse events or deaths were reported. Post-vaccination antibody responses, seroconversion rates, and seroprotection rates for the 3 strains common to both vaccines were comparable for IIV3 and IIV4 in both age groups. Antibody responses to IIV4 were equivalent among vaccine lots and comparable between age groups for each of the 4 strains. IIV4 met all European Medicines Agency immunogenicity criteria for adults for all 4 strains. CONCLUSIONS:In both age groups, IIV4 was well tolerated and caused no safety concerns, induced robust antibody responses to all 4 influenza strains, and met all EMA immunogenicity criteria for adults. CLINICAL TRIAL REGISTRY NUMBER:NCT01481454.

journal_name

Vaccine

journal_title

Vaccine

authors

Cadorna-Carlos JB,Nolan T,Borja-Tabora CF,Santos J,Montalban MC,de Looze FJ,Eizenberg P,Hall S,Dupuy M,Hutagalung Y,Pépin S,Saville M

doi

10.1016/j.vaccine.2015.03.065

subject

Has Abstract

pub_date

2015-05-15 00:00:00

pages

2485-92

issue

21

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(15)00384-9

journal_volume

33

pub_type

杂志文章,多中心研究,随机对照试验

相关文献

VACCINE文献大全
  • Immunisation of chickens with live Salmonella vaccines - Role of booster vaccination.

    abstract：:It is accepted that booster vaccinations of chickens with live Salmonella vaccines are essential part of vaccinations schemes to induce an effective adaptive immune response. As manufacturer of registered live Salmonella vaccines recommend different times of booster the question raises whether the duration between the...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2018.04.041

    authors： Methner U

    更新日期：2018-05-17 00:00:00

  • Safety and immunogenicity in volunteers of a recombinant Plasmodium falciparum circumsporozoite protein malaria vaccine produced in Lepidopteran cells.

    abstract：:A recombinant Plasmodium falciparum circumsporozoite (CS) antigen (rPfCSA) was produced in insect cells using a baculovirus expression vector containing the entire CS gene. This near full-length CS antigen was adsorbed onto aluminium phosphate for use as a malaria vaccine. In a study of safety and immunogenicity, 20 v...

    journal_title：Vaccine

    pub_type： 临床试验,杂志文章

    doi：10.1016/0264-410x(92)90047-n

    authors： Herrington DA,Losonsky GA,Smith G,Volvovitz F,Cochran M,Jackson K,Hoffman SL,Gordon DM,Levine MM,Edelman R

    更新日期：1992-01-01 00:00:00

  • Influenza virus antigens conjugated with a synthetic polyelectrolyte: a novel model of vaccines.

    abstract：:Haemagglutinin (HA), a mixture of haemagglutinin and neuraminidase (HA + NA), and matrix (M) protein were isolated from the influenza A virus and covalently coupled to a synthetic polyelectrolyte (P). A single injection into mice of the resultant conjugates (virogates) brought about efficient stimulation of the primar...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/0264-410x(85)90130-6

    authors： Petrov RV,Khaitov RM,Zhdanov VM,Sinyakov MS,Norimov ASh,Nekrasov AV,Podchernyaeva RYa,Kharitonenkov IG,Shchipanova MV

    更新日期：1985-12-01 00:00:00

  • Measles seroprevalence in Chiradzulu district, Malawi: Implications for evaluating vaccine coverage.

    abstract：INTRODUCTION:Self-reported measles vaccination coverage is frequently used to inform vaccination strategies in resource-poor settings. However, little is known to what extent this is a reliable indicator of underlying seroprotection, information that could provide guidance ensuring the success of measles control and el...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2015.07.007

    authors： Polonsky JA,Juan-Giner A,Hurtado N,Masiku C,Kagoli M,Grais RF

    更新日期：2015-08-26 00:00:00

  • Immunogenicity and safety of tetravalent dengue vaccine in 2-11 year-olds previously vaccinated against yellow fever: randomized, controlled, phase II study in Piura, Peru.

    abstract：:In a randomized, placebo-controlled, monocenter, observer blinded study conducted in an area where dengue is endemic, we assessed the safety and immunogenicity of a recombinant, live, attenuated, tetravalent dengue vaccine candidate (CYD-TDV) in 2-11 year-olds with varying levels of pre-existing yellow-fever immunity ...

    journal_title：Vaccine

    pub_type： 杂志文章,随机对照试验

    doi：10.1016/j.vaccine.2012.07.043

    authors： Lanata CF,Andrade T,Gil AI,Terrones C,Valladolid O,Zambrano B,Saville M,Crevat D

    更新日期：2012-09-07 00:00:00

  • Amended recombinant cells (ARCs) expressing bovine IFN-gamma: an economical and highly effective adjuvant system.

    abstract：:Interferon-gamma (IFN-gamma) has potent immune stimulatory activity, but purifying recombinant protein is expensive, soluble cytokine delivery is inefficient, and high doses of IFN-gamma cause adverse systemic effects. We've shown, however, that chemically fixed, amended recombinant Pseudomonas fluorescens cells (ARCs...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2008.12.049

    authors： Gaertner FH,Babiuk LA,Mutwiri G,Armstrong JM,Griebel PJ

    更新日期：2009-02-25 00:00:00

  • Double-blind, randomized, placebo-controlled Phase I Clinical Trial of the therapeutical antituberculous vaccine RUTI.

    abstract：:A Phase I interventional Clinical Trial was performed with a potential tuberculosis vaccine, based on detoxified cellular fragments of M. tuberculosis, named RUTI. The objective was to evaluate the safety profile and T-cell immune responses over a 6-month period following subcutaneous inoculation. The double-blind, ra...

    journal_title：Vaccine

    pub_type： 杂志文章,随机对照试验

    doi：10.1016/j.vaccine.2009.09.134

    authors： Vilaplana C,Montané E,Pinto S,Barriocanal AM,Domenech G,Torres F,Cardona PJ,Costa J

    更新日期：2010-01-22 00:00:00

  • Specific memory B cell response and participation of CD4+ central and effector memory T cells in mice immunized with liposome encapsulated recombinant NE protein based Hepatitis E vaccine candidate.

    abstract：BACKGROUND:Liposome encapsulated neutralizing epitope protein of Hepatitis E virus (HEV), rNEp, our Hepatitis E vaccine candidate, was shown to be immunogenic and safe in pregnant and non-pregnant mice and yielded sterilizing immunity in rhesus monkeys. METHODS:The current study in Balb/c mice assessed the levels and ...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2016.10.046

    authors： Kulkarni SP,Thanapati S,Arankalle VA,Tripathy AS

    更新日期：2016-11-21 00:00:00

  • Comparing human T cell and NK cell responses in viral-based malaria vaccine trials.

    abstract：:Vaccination with viral-based vaccines continues to hold promise for the prevention of malaria. Whilst antigen-specific T cell responses are considered a major aim of such an approach, a role for induced NK cells as anti-malarial effector cells, or in shaping T cell responses, has received less attention. In this study...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2009.09.132

    authors： Berthoud TK,Fletcher H,Porter D,Thompson F,Hill AV,Todryk SM

    更新日期：2009-12-10 00:00:00

  • Compatibility of a live infectious bovine rhinotraheitis (IBR) marker vaccine and an inactivated bovine viral diarrhoea virus (BVDV) vaccine.

    abstract：:The target animals and vaccination regimes for vaccines against the bovine rhinotracheitis (IBR) and the bovine viral diarrhoea virus (BVDV) are very similar. Therefore, we have compared different schedules for the combined use of a live IBR marker vaccine and an inactivated BVD vaccine. The neutralizing antibody resp...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2007.06.050

    authors： Alvarez M,Bielsa JM,Santos L,Makoschey B

    更新日期：2007-09-04 00:00:00

  • Human papillomavirus (HPV) vaccination and subsequent sexual behaviour: evidence from a large survey of Nordic women.

    abstract：OBJECTIVE:To assess whether recipients and non-recipients of the human papillomavirus (HPV) vaccine subsequently differ in terms of sexual risk taking behaviour. DESIGN:Cross-sectional survey. Sequential analyses constructed from self-reported age at vaccination, age at first intercourse and age at response. SETTING:...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2014.07.025

    authors： Hansen BT,Kjær SK,Arnheim-Dahlström L,Liaw KL,Jensen KE,Thomsen LT,Munk C,Nygård M

    更新日期：2014-09-03 00:00:00

  • Vero-cell rabies vaccine produced using serum-free medium.

    abstract：:A new rabies vaccine was developed from Vero cells adhered to microcarriers, cultivated in a bioreactor in serum-free medium and infected with the PV/VERO-Paris rabies virus strain. The viral suspensions were concentrated by tangential filtration, purified by chromatography and inactivated with beta-propiolactone. In ...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2004.06.014

    authors： Frazatti-Gallina NM,Mourão-Fuches RM,Paoli RL,Silva ML,Miyaki C,Valentini EJ,Raw I,Higashi HG

    更新日期：2004-12-09 00:00:00

  • Inactivated influenza vaccine adjuvanted with bacterium-like particles induce systemic and mucosal influenza A virus specific T-cell and B-cell responses after nasal administration in a TLR2 dependent fashion.

    abstract：BACKGROUND:Nasal vaccination is considered to be a promising alternative for parenteral vaccination against influenza virus as it is non-invasive and offers the opportunity to elicit strong antigen-specific responses both systemic and locally at the port of entry of the pathogen. Previous studies showed that non-living...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2014.02.019

    authors： Keijzer C,Haijema BJ,Meijerhof T,Voorn P,de Haan A,Leenhouts K,van Roosmalen ML,van Eden W,Broere F

    更新日期：2014-05-19 00:00:00

  • Characterization and optimization of a novel vaccine for protection against Lyme borreliosis.

    abstract：:Lyme borreliosis (LB) is the most common vector-borne disease in the northern hemisphere and there is no vaccine available for disease prevention. The majority of LB cases in Europe are caused by four different Borrelia species expressing six different OspA serotypes, whereas in the US only one of these serotypes is p...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2015.07.095

    authors： Comstedt P,Hanner M,Schüler W,Meinke A,Schlegl R,Lundberg U

    更新日期：2015-11-04 00:00:00

  • Enhanced protective efficacy of Borrelia burgdorferi BB0172 derived-peptide based vaccine to control Lyme disease.

    abstract：:Lyme disease (LD) accounts for over 70% of tick-borne disease reported in the United States. The disease in humans is characterized by skin rash, arthritis, cardiac and neurological signs. Vaccination is the most efficient preventive measure that could be taken to reduce the incidence of the LD worldwide; however, at ...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2019.07.092

    authors： Hassan WS,Giaretta PR,Rech R,Ollivault-Shiflett M,Esteve-Gasent MD

    更新日期：2019-09-03 00:00:00

  • Using pCIN-mIL-4 DNA vector to express mRNA and protein and to improve herpes simplex virus-induced Behcet's disease symptoms in mice.

    abstract：:Behcet's disease (BD) is a chronic, recurrent, inflammatory, multisystemic disorder characterized primarily by vasculitis. The etiopathogenesis of BD involves immunogenetics, infectious organisms (streptococcus, herpes simplex virus), immunoregulation and vascular dysfunctions. We previously found that immunoregulatio...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2007.07.062

    authors： Lee SI,Kwon HJ,Lee ES,Yang BC,Bang D,Lee S,Sohn S

    更新日期：2007-10-10 00:00:00

  • Maternal immune status influences HIV-specific immune responses in pups after DNA prime protein boost using mucosal adjuvant.

    abstract：:This study was designed to determine the impact of maternal HIV-1 specific immunity on HIV-DNA immunization of 2-week-old pups during the breast-feeding period. Adult female mice received intranasal or intradermal HIV-DNA (gp160Env, p37Gag, Nef, Tat and Rev) prime and recombinant protein boost immunizations, which ind...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2008.08.060

    authors： Bråve A,Johansen K,Palma P,Benthin R,Hinkula J

    更新日期：2008-11-05 00:00:00

  • Antibody levels against tetanus and diphtheria after polychemotherapy for childhood sarcoma: a report from the Late Effects Surveillance System.

    abstract：BACKGROUND:It is known that antineoplastic treatment may induce secondary immunodeficiency, but studies after childhood sarcoma are rare. Since 1998, the Late Effects Surveillance System (LESS) of the German Society for Paediatric Oncology and Haematology (GPOH) prospectively registers late effects in soft tissue-, ost...

    journal_title：Vaccine

    pub_type： 杂志文章,多中心研究

    doi：10.1016/j.vaccine.2010.12.084

    authors： Paulides M,Stöhr W,Laws HJ,Graf N,Lakomek M,Berthold F,Schmitt K,Niggli F,Jürgens H,Bielack S,Koscielniak E,Klingebiel T,Langer T

    更新日期：2011-02-11 00:00:00

  • Human rotavirus genotypes in hospitalized children, South Korea, April 2005 to March 2007.

    abstract：:Availability of new rotavirus vaccines highlights the need to maintain and enhance rotavirus strain surveillance. We collected stool samples from children with gastroenteritis admitted to eight hospitals in South Korea from April 2005 to March 2007. Of the 6057 samples collected, 1337 (22%) were positive for rotavirus...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2009.09.002

    authors： Lee SY,Hong SK,Lee SG,Suh CI,Park SW,Lee JH,Kim JH,Kim DS,Kim HM,Jang YT,Ma SH,Kim SY,Sohn YS,Kang JH,Paik SY

    更新日期：2009-11-20 00:00:00

  • The influence of gamma inulin and Algammulin on the immune response in sheep to a recombinant antigen of Taenia ovis.

    abstract：:Gamma inulin and Algammulin, two new adjuvants, were examined and compared with alum and Freund's Complete/Incomplete Adjuvant (FCA/FIA), for potentiation of cell-mediated immunity (CMI) and humoral immunity in sheep to a recombinant Taenia ovis antigen. The ability to protect sheep when challenged with live T. ovis e...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/0264-410x(94)00023-g

    authors： Deol HS,Palmer DG,Dunsmore T,Carnegie PR

    更新日期：1995-04-01 00:00:00

  • Influenza and pneumococcal vaccination and risk of stroke or transient ischaemic attack-matched case control study.

    abstract：BACKGROUND:Evidence that respiratory infections trigger stroke suggests that influenza or pneumococcal vaccination might prevent stroke. We aimed to investigate whether influenza or pneumococcal vaccination or both together were associated with reduced risk of stroke or transient ischaemic attack (TIA). METHODS:We use...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2014.01.029

    authors： Siriwardena AN,Asghar Z,Coupland CC

    更新日期：2014-03-10 00:00:00

  • Eleven years of Inflexal V-a virosomal adjuvanted influenza vaccine.

    abstract：:Since the introduction to the Swiss market in 1997, Crucell (former Berna Biotech Ltd.), has sold over 41 million doses worldwide of the virosomal adjuvanted influenza vaccine, Inflexal V. Since 1992, 29 company sponsored clinical studies investigating the efficacy and safety of Inflexal V have been completed in which...

    journal_title：Vaccine

    pub_type： 杂志文章,评审

    doi：10.1016/j.vaccine.2009.05.029

    authors： Herzog C,Hartmann K,Künzi V,Kürsteiner O,Mischler R,Lazar H,Glück R

    更新日期：2009-07-16 00:00:00

  • Development and phase 1 clinical testing of a conjugate vaccine against meningococcus A and C.

    abstract：:A conjugate vaccine against meningococcus A and C was prepared using the non-toxic mutant of diphtheria toxin CRM 197 as a carrier protein. Capsular polysaccharides of Neisseria meningitidis group A and C were hydrolysed and the resulting oligosaccharides were then coupled to CRM 197 in order to obtain conjugates with...

    journal_title：Vaccine

    pub_type： 临床试验,杂志文章

    doi：10.1016/0264-410x(92)90091-w

    authors： Costantino P,Viti S,Podda A,Velmonte MA,Nencioni L,Rappuoli R

    更新日期：1992-01-01 00:00:00

  • Differences between coverage of yellow fever vaccine and the first dose of measles-containing vaccine: A desk review of global data sources.

    abstract：INTRODUCTION:The strategy to Eliminate Yellow Fever Epidemics (EYE) is a global initiative that includes all countries with risk of yellow fever (YF) virus transmission. Of these, 40 countries (27 in Africa and 13 in the Americas) are considered high-risk and targeted for interventions to increase coverage of YF vaccin...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2019.06.063

    authors： Adrien N,Hyde TB,Gacic-Dobo M,Hombach J,Krishnaswamy A,Lambach P

    更新日期：2019-07-26 00:00:00

  • Immunogenicity and safety of monovalent p1.7(h),4 meningococcal outer membrane vesicle vaccine in toddlers: comparison of two vaccination schedules and two vaccine formulations.

    abstract：:The safety and immunogenicity of two PorA-based meningococcal outer membrane vesicle (OMV) vaccines against the P1.4 serosubtype adsorbed with AlPO(4) or Al(OH)(3) were studied in 134 toddlers. Vaccinations were given three times with an interval of 3-6 weeks or twice with an interval of 6-10 weeks. A vaccination was ...

    journal_title：Vaccine

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1016/s0264-410x(00)00320-0

    authors： de Kleijn ED,de Groot R,Lafeber AB,Labadie J,van Limpt KC,Visser J,Berbers GA,van Alphen L,Rümke HC

    更新日期：2000-12-08 00:00:00

  • Assessing the adequacy of attenuation of genetically modified malaria parasite vaccine candidates.

    abstract：:The critical first step in the clinical development of a malaria vaccine, based on live-attenuated Plasmodium falciparum sporozoites, is the guarantee of complete arrest in the liver. We report on an approach for assessing adequacy of attenuation of genetically attenuated sporozoites in vivo using the Plasmodium bergh...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2012.02.010

    authors： Annoura T,Ploemen IH,van Schaijk BC,Sajid M,Vos MW,van Gemert GJ,Chevalley-Maurel S,Franke-Fayard BM,Hermsen CC,Gego A,Franetich JF,Mazier D,Hoffman SL,Janse CJ,Sauerwein RW,Khan SM

    更新日期：2012-03-30 00:00:00

  • How many published cases of serious adverse events after yellow fever vaccination meet Brighton Collaboration diagnostic criteria?

    abstract：OBJECTIVES:To perform a systematic review of all serious adverse events (SAEs) after yellow fever vaccination and to assess them according to Brighton Collaboration criteria. METHODS:Nine electronic databases were searched with the terms "yellow fever vaccine" and "adverse events" to 10 July 2013 (no language/date lim...

    journal_title：Vaccine

    pub_type： 杂志文章,评审

    doi：10.1016/j.vaccine.2013.10.050

    authors： Thomas RE,Spragins W,Lorenzetti DL

    更新日期：2013-12-16 00:00:00

  • Early studies on DNA-based immunizations for measles virus.

    abstract：:DNA-mediated immunizations have been used to raise neutralizing antibodies for measles virus. Single inoculations of plasmids expressing measles hemagglutinin or fusion glycoproteins raised neutralizing antibody in BALB/c mice. Plasmids expressing the hemagglutinin glycoprotein (both normal and secreted) raised neutra...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/s0264-410x(96)00261-7

    authors： Yang K,Mustafa F,Valsamakis A,Santoro JC,Griffin DE,Robinson HL

    更新日期：1997-06-01 00:00:00

  • The bovine viral diarrhea virus E2 protein formulated with a novel adjuvant induces strong, balanced immune responses and provides protection from viral challenge in cattle.

    abstract：:Bovine viral diarrhea virus (BVDV) is still one of the most serious pathogens in cattle, meriting the development of improved vaccines. Recently, we developed a new adjuvant consisting of poly[di(sodium carboxylatoethylphenoxy)]-phosphazene (PCEP), either CpG ODN or poly(I:C), and an immune defense regulator (IDR) pep...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2014.10.010

    authors： Snider M,Garg R,Brownlie R,van den Hurk JV,van Drunen Littel-van den Hurk S

    更新日期：2014-11-28 00:00:00

  • Use of fusion protein constructs to generate potent immunotherapy and protection against scorpion toxins.

    abstract：:We report the use of recombinant scorpion toxins in the form of fusion proteins as antigens for immunisation in rabbits and mice: the aim was to produce in these animal models protective antisera against the most lethal alpha-type toxins in the venom from the North African scorpion Androctonus australis. The cDNAs enc...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/s0264-410x(01)00379-6

    authors： Legros C,Kaabi H,El Ayeb M,Céard B,Vacher H,Bougis PE,Martin-Eauclaire MF

    更新日期：2001-12-12 00:00:00