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Article ; Online: Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16.

Bricout, Hélène / Chabanon, Anne Laure / Souverain, Audrey / Sadorge, Christine / Vesikari, Timo / Caroe, Timothy David

Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin

2017 Volume 22, Issue 18

Abstract: Enhanced safety surveillance (ESS) was conducted in the United Kingdom and Finland for Vaxigrip and Intanza 15 µg to comply with the European Medicines Agency interim guidance aimed to detect any potential increase in reactogenicity in near real time ... ...

Abstract	Enhanced safety surveillance (ESS) was conducted in the United Kingdom and Finland for Vaxigrip and Intanza 15 µg to comply with the European Medicines Agency interim guidance aimed to detect any potential increase in reactogenicity in near real time following the annual update of the influenza vaccine strain composition. This pilot passive ESS was established to strengthen safety monitoring by facilitating spontaneous vaccinee reports and estimating near real-time vaccinee exposure. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days post vaccination during the northern hemisphere 2015/16 influenza season. Among the Vaxigrip vaccinees (n = 1,012), 32 (3.2%) reported a total of 122 suspected ARs, including 110 suspected ARs that occurred within 7 days post vaccination. Among the Intanza 15 µg vaccinees (n = 1,017), 31 (3.0%) reported a total of 114 suspected ARs, including 99 that occurred within 7 days post-vaccination. These results were consistent with the known safety profile of the two vaccines and did not show any change in reactogenicity or safety concerns. This passive ESS showed improved data reporting and demonstrated its suitability to health authorities' requirements; further fine tuning of the methodology is under discussion between all stakeholders.
Language	English
Publishing date	2017-05-04
Publishing country	Sweden
Document type	Journal Article
ZDB-ID	1338803-4
ISSN	1560-7917 ; 1025-496X
ISSN (online)	1560-7917
ISSN	1025-496X
DOI	10.2807/1560-7917.ES.2017.22.18.30527
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Article ; Online: Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib).

Martinón-Torres, Federico / Boisnard, Florence / Thomas, Stéphane / Sadorge, Christine / Borrow, Ray

Vaccine

2017 Volume 35, Issue 30, Page(s) 3764–3772

Abstract: DTaP5-IPV-HB-Hib vaccine is a fully-liquid, combination hexavalent vaccine. This phase III, open-label, multicentre study conducted in Spain, evaluated the immune response to all DTaP5-IPV-HB-Hib antigens when the vaccine was used in a mixed hexa/penta/ ... ...

Abstract	DTaP5-IPV-HB-Hib vaccine is a fully-liquid, combination hexavalent vaccine. This phase III, open-label, multicentre study conducted in Spain, evaluated the immune response to all DTaP5-IPV-HB-Hib antigens when the vaccine was used in a mixed hexa/penta/hexa primary series. Infants (who had received one dose of hepatitis B vaccine at birth) received a mixed schedule including DTaP5-IPV-HB-Hib (PRP-OMP conjugate) at 2 and 6months of age, DTaP5-IPV-Hib at 4months, meningococcal serogroup C conjugate (MCC) vaccine at 2 and 4months, and routine rotavirus and pneumococcal vaccination. One month post-dose 3 of the mixed schedule, response rates were considered acceptable if the lower bound of the two-sided 95% confidence interval around the post-vaccination response rate was >90% for hepatitis B and >80% for Haemophilus influenzae type b (Hib). Secondary immunogenicity objectives included description of the antibody response to all hexavalent antigens one month after completion of the mixed schedule, and to MCC antigen one month after the second MCC dose. The safety profile after each dose of study vaccine was described. Of 385 healthy infants enrolled, 384 completed the study. The primary objective was achieved for both hepatitis B and Hib; the lower bound of the 2-sided 95% CI of the response rates (97.2% and 99.0%, respectively) were greater than the pre-specified acceptability thresholds. One month post-dose 3 of the mixed schedule, all participants were seroprotected against diphtheria, tetanus and polio. The mixed schedule induced a robust immune response to all hexavalent antigens. The co-administration of the hexavalent vaccine in a mixed schedule with MCC vaccine did not reduce the immune response to vaccine antigens. Vaccines were well tolerated. In conclusion, the acceptability of response rates against Hib and hepatitis B were demonstrated one month post-dose 3 of the mixed schedule; robust immune responses against all other hexavalent antigens were observed. clinicaltrial.gov: NCT01839188; EudraCT: 2012-004221-25.
Language	English
Publishing date	2017-06-27
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2017.05.043
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Article ; Online: Diphtheria, tetanus and poliovirus antibody persistence 5 years after vaccination of pre-schoolers with two different diphtheria, tetanus and inactivated poliomyelitis vaccines (Td-IPV or DT-IPV) and immune responses to a booster dose of DTaP-IPV.

Gajdos, Vincent / Vidor, Emmanuel / Richard, Patrick / Tran, Clément / Sadorge, Christine

Vaccine

2015 Volume 33, Issue 32, Page(s) 3988–3996

Abstract: Introduction: This follow-up study assessed the 5-year persistence of vaccine-induced antibodies (Td-IPV or DT-IPV) and the immune response to a booster dose of DTaP-IPV.: Methods: This was an open-label, parallel-group (two arms), multicentre trial ... ...

Abstract	Introduction: This follow-up study assessed the 5-year persistence of vaccine-induced antibodies (Td-IPV or DT-IPV) and the immune response to a booster dose of DTaP-IPV. Methods: This was an open-label, parallel-group (two arms), multicentre trial performed at 44 study sites in France. Children aged 11-13 years, of either sex, who received Td-IPV (Revaxis(®)) and DT-IPV (DT Polio(®)) vaccines at 6 years of age in one previous open-label trial with no further vaccination against diphtheria, tetanus, pertussis or poliomyelitis, were enrolled. All participants received a single intramuscular booster dose (0.5mL) of DTaP-IPV vaccine (Tetravac-Acellulaire(®)). Study endpoints were based on antibody persistence and post-booster immune responses. Safety was monitored throughout the study. Descriptive statistics were used for all analyses. Results: Of the 758 children included in the previous study, 274 were included in this follow-up study; 129 had previously been vaccinated with Td-IPV, and 145 had previously received DT-IPV. At least 96.5% of participants in both groups presented an anti-diphtheria and anti-tetanus concentration ≥0.01IU/mL, and anti-poliovirus types 1-3 titres≥8 (1/dilution). Following vaccination with DTaP-IPV, anti-diphtheria and anti-tetanus antibody concentrations ≥0.1IU/mL and anti-poliovirus types 1-3 antibody titres ≥8 (1/dilution) were achieved in all participants. DTaP-IPV was well tolerated in this study. There were no serious adverse events during the study, and no participant withdrew because of adverse events. Discussion: The present study confirmed the long-term immunity conferred by Td-IPV when given as a booster dose, and supports the use of Td-IPV as a second booster at 6 years of age in children previously vaccinated against diphtheria, tetanus and poliomyelitis types 1-3.
MeSH term(s)	Adolescent ; Antibodies, Bacterial/blood ; Antibodies, Viral/blood ; Child ; Child, Preschool ; Diphtheria-Tetanus Vaccine/administration & dosage ; Diphtheria-Tetanus Vaccine/adverse effects ; Diphtheria-Tetanus Vaccine/immunology ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Female ; Follow-Up Studies ; France ; Humans ; Immunization, Secondary ; Injections, Intramuscular ; Male ; Poliovirus Vaccine, Inactivated/administration & dosage ; Poliovirus Vaccine, Inactivated/adverse effects ; Poliovirus Vaccine, Inactivated/immunology ; Treatment Outcome
Chemical Substances	Antibodies, Bacterial ; Antibodies, Viral ; Diphtheria-Tetanus Vaccine ; Poliovirus Vaccine, Inactivated
Language	English
Publishing date	2015-07-31
Publishing country	Netherlands
Document type	Clinical Study ; Comparative Study ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2015.06.036
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Article: Randomized clinical trial of DTaP5-HB-IPV-Hib vaccine administered concomitantly with meningococcal serogroup C conjugate vaccines during the primary infant series

Oliver, Jennifer L / Sadorge, Christine / Boisnard, Florence / Snape, Matthew D / Tomlinson, Richard / Mann, Rebecca / Rudd, Peter / Bhakthavalsala, Shyam / Faust, Saul N / Heath, Paul T / Hughes, Stephen M / Borrow, Ray / Thomas, Stéphane / Finn, Adam

Vaccine. 2020 July 31, v. 38, no. 35

2020

Abstract: Concomitant administration of vaccines simplifies delivery. DTaP5-HB-IPV-Hib is a fully liquid, combination vaccine against 6 diseases. This study evaluated the compatibility of DTaP5-HB-IPV-Hib with 2 different meningococcus group C conjugate (MCC) ... ...

Abstract	Concomitant administration of vaccines simplifies delivery. DTaP5-HB-IPV-Hib is a fully liquid, combination vaccine against 6 diseases. This study evaluated the compatibility of DTaP5-HB-IPV-Hib with 2 different meningococcus group C conjugate (MCC) vaccines in infants.In a phase 3, open-label study, 284 healthy infants from 11 UK centres received DTaP5-HB-IPV-Hib at age 2, 3, and 4 months; 13-valent pneumococcal conjugate vaccine (PCV13) at 2 and 4 months; a Haemophilus influenzae type b (Hib)-MCC vaccine and a measles/mumps/rubella vaccine at 12 months. Participants were randomised 1:1 to receive either an MCC-detoxified tetanus toxin vaccine (MCC-TT; n = 141) or an MCC-Corynebacterium diphtheriae CRM₁₉₇ protein vaccine (MCC-CRM; n = 143) at 3 and 4 months. The primary outcome was seroprotection rate (SPR) to MCC (percent with rabbit complement serum bactericidal antibody titer ≥8).Per protocol analysis, MCC SPRs were 100 and 96.4 one month after the first dose, 100 and 99.1 after the second dose, and 100 and 97.3 after the third (booster) dose of MCC in the MCC-TT and MCC-CRM groups, respectively. One month after all 3 doses of DTaP5-HB-IPV-Hib, immunoglobulin G anti-polyribosylribitol phosphate SPRs (% ≥0.15 µg/mL) were 97.8 in the MCC-TT group and 100 in the MCC-CRM group; anti-hepatitis B antigen SPRs (% ≥10 mIU/mL) were 96.8 and 96.3 in the MCC-TT and MCC-CRM groups, respectively. All participants were seroprotected against diphtheria and tetanus (≥0.01 IU/mL) and poliovirus types 1, 2, and 3 (≥8 dilution), and seroresponse rates to all pertussis antigens were ≥90.4%. Two vaccine-related serious adverse events (transient severe abdominal pain and crying) occurred concomitantly in 1 participant in the MCC-CRM group. Adverse event rates were similar to other studies of DTaP5-HB-IPV-Hib, with pyrexia ≥38 °C in 10.9% of participants following any dose.DTaP5-HB-IPV-Hib can be effectively used in a 2-, 3-, and 4-month infant priming schedule when given with 2 doses of MCC.
Keywords	Haemophilus influenzae ; Streptococcus pneumoniae ; antibodies ; antigens ; blood serum ; complement ; diphtheria ; fever ; immunoglobulin G ; liquids ; measles ; pain ; phosphates ; rabbits ; randomized clinical trials ; serotypes ; tetanus ; toxins ; vaccines
Language	English
Dates of publication	2020-0731
Size	p. 5718-5725.
Publishing place	Elsevier Ltd
Document type	Article
Note	NAL-AP-2-clean
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2020.06.015
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Article ; Online: Immunogenicity and safety of ZOSTAVAX(®) approaching expiry potency in individuals aged ≥50 years.

Arnou, Robert / Fiquet, Anne / Thomas, Stéphane / Sadorge, Christine

Human vaccines

2011 Volume 7, Issue 10, Page(s) 1060–1065

Abstract: Background: Age is a major risk factor for herpes zoster (HZ) and its potential long-term complication post-herpetic neuralgia (PHN). Due to the significant burden of HZ and PHN on patients' quality of life, it is vital that effective and well-tolerated ...

Abstract	Background: Age is a major risk factor for herpes zoster (HZ) and its potential long-term complication post-herpetic neuralgia (PHN). Due to the significant burden of HZ and PHN on patients' quality of life, it is vital that effective and well-tolerated vaccines are available to prevent HZ in older adults. ZOSTAVAX(®) vaccine was developed to prevent HZ and PHN in individuals ≥50 years (y) of age, and its clinical efficacy and safety have been demonstrated. Aims and methods: This phase 4, open-label, multicenter study was undertaken to assess the immunogenicity and safety of a single dose of ZOSTAVAX (refrigerator-stable formulation) given within 6 mo of its expiry date in individuals ≥50 y of age. The geometric mean fold rise (GMFR) from pre-vaccination to 4 weeks post-vaccination in varicella zoster virus (VZV) antibody titers was calculated. An acceptable antibody response was defined as a lower 95% confidence interval (CI) of GMFR > 1.4. Solicited and unsolicited injection-site reactions and systemic adverse events were recorded. Results: The GMFR in VZV antibody titers was 3.1 (95% CI: 2.6, 3.8), satisfying the criterion for an acceptable VZV antibody response to ZOSTAVAX (minimum requirement: 1.4 GMFR). An acceptable rise in VZV antibody titers was observed in individuals of 50-59 y of age (GMFR 3.9; 95% CI: 2.9, 5.1) and in those ≥60 y of age (GMFR 2.5; 95% CI: 1.9, 3.2). ZOSTAVAX was well tolerated; no serious adverse events were reported. Conclusion: ZOSTAVAX elicits an acceptable immune response in immunocompetent individuals ≥50 y of age when stored as directed and administered during the 6 mo prior to expiration.
MeSH term(s)	Aged ; Aged, 80 and over ; Antibodies, Viral/blood ; Double-Blind Method ; Female ; Herpes Zoster/prevention & control ; Herpes Zoster Vaccine/administration & dosage ; Herpes Zoster Vaccine/adverse effects ; Herpes Zoster Vaccine/immunology ; Humans ; Male ; Middle Aged ; Neuralgia, Postherpetic/prevention & control
Chemical Substances	Antibodies, Viral ; Herpes Zoster Vaccine
Language	English
Publishing date	2011-10-01
Publishing country	United States
Document type	Clinical Trial, Phase IV ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	1554-8619
ISSN (online)	1554-8619
DOI	10.4161/hv.7.10.16480
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Article ; Online: Randomized clinical trial of DTaP5-HB-IPV-Hib vaccine administered concomitantly with meningococcal serogroup C conjugate vaccines during the primary infant series.

Vaccine

2020 Volume 38, Issue 35, Page(s) 5718–5725

Abstract: Background: Concomitant administration of vaccines simplifies delivery. DTaP5-HB-IPV-Hib is a fully liquid, combination vaccine against 6 diseases. This study evaluated the compatibility of DTaP5-HB-IPV-Hib with 2 different meningococcus group C ... ...

Abstract	Background: Concomitant administration of vaccines simplifies delivery. DTaP5-HB-IPV-Hib is a fully liquid, combination vaccine against 6 diseases. This study evaluated the compatibility of DTaP5-HB-IPV-Hib with 2 different meningococcus group C conjugate (MCC) vaccines in infants. Methods: In a phase 3, open-label study, 284 healthy infants from 11 UK centres received DTaP5-HB-IPV-Hib at age 2, 3, and 4 months; 13-valent pneumococcal conjugate vaccine (PCV13) at 2 and 4 months; a Haemophilus influenzae type b (Hib)-MCC vaccine and a measles/mumps/rubella vaccine at 12 months. Participants were randomised 1:1 to receive either an MCC-detoxified tetanus toxin vaccine (MCC-TT; n = 141) or an MCC-Corynebacterium diphtheriae CRM Results: Per protocol analysis, MCC SPRs were 100 and 96.4 one month after the first dose, 100 and 99.1 after the second dose, and 100 and 97.3 after the third (booster) dose of MCC in the MCC-TT and MCC-CRM groups, respectively. One month after all 3 doses of DTaP5-HB-IPV-Hib, immunoglobulin G anti-polyribosylribitol phosphate SPRs (% ≥0.15 µg/mL) were 97.8 in the MCC-TT group and 100 in the MCC-CRM group; anti-hepatitis B antigen SPRs (% ≥10 mIU/mL) were 96.8 and 96.3 in the MCC-TT and MCC-CRM groups, respectively. All participants were seroprotected against diphtheria and tetanus (≥0.01 IU/mL) and poliovirus types 1, 2, and 3 (≥8 dilution), and seroresponse rates to all pertussis antigens were ≥90.4%. Two vaccine-related serious adverse events (transient severe abdominal pain and crying) occurred concomitantly in 1 participant in the MCC-CRM group. Adverse event rates were similar to other studies of DTaP5-HB-IPV-Hib, with pyrexia ≥38 °C in 10.9% of participants following any dose. Conclusions: DTaP5-HB-IPV-Hib can be effectively used in a 2-, 3-, and 4-month infant priming schedule when given with 2 doses of MCC.
MeSH term(s)	Animals ; Antibodies, Bacterial ; Diphtheria-Tetanus-Pertussis Vaccine ; Haemophilus Vaccines ; Haemophilus influenzae type b ; Humans ; Infant ; Meningococcal Vaccines ; Poliovirus Vaccine, Inactivated ; Rabbits ; Serogroup ; Vaccines, Combined ; Vaccines, Conjugate
Chemical Substances	Antibodies, Bacterial ; Diphtheria-Tetanus-Pertussis Vaccine ; Haemophilus Vaccines ; Meningococcal Vaccines ; Poliovirus Vaccine, Inactivated ; Vaccines, Combined ; Vaccines, Conjugate
Language	English
Publishing date	2020-07-10
Publishing country	Netherlands
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2020.06.015
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Article ; Online: The predicted persistence and kinetics of antibody decline 9years after pre-school booster vaccination in UK children.

Voysey, Merryn / Kandasamy, Rama / Yu, Ly-Mee / Baudin, Martine / Sadorge, Christine / Thomas, Stéphane / John, Tessa / Pollard, Andrew J

Vaccine

2016 Volume 34, Issue 35, Page(s) 4221–4228

Abstract: Background: Long term follow-up of vaccine trials is essential to establish the duration of protection. In the context of worldwide concern about rising pertussis incidence, estimates of antibody persistence after vaccination, which do not account for ... ...

Abstract	Background: Long term follow-up of vaccine trials is essential to establish the duration of protection. In the context of worldwide concern about rising pertussis incidence, estimates of antibody persistence after vaccination, which do not account for the rise in antibody due to natural boosting or infection, may overestimate the degree of protection afforded by pertussis vaccines. Methods: This was a 5year follow up study of a randomised controlled trial of diphtheria, tetanus, pertussis and polio booster vaccines in UK children aged 3.5-5years. Antibody persistence was measured at 1month, 1, 3, and 5years after vaccination and the kinetics of antibody decline were modelled longitudinally. Estimates of predicted antibody persistence 9years after the pre-school booster were derived from model parameters. Results: Antibody levels 9years after vaccination were predicted to be above accepted thresholds for protection for diphtheria, tetanus and polio. Antibody responses to pertussis toxoid were undetectable in 49% of children at the 5year follow up visit, and responses were predicted to be undetectable in 69% (95% CI 45-88%) of children by the time of their teenage booster at 13-14years of age. Conclusions: There is no defined correlate of protection for pertussis. However, the large proportion of participants in this study with undetectable pertussis antibody levels at both measured and predicted timepoints suggests sub-optimal immunity in adolescence. Adding pertussis to the teenage booster for UK children as is done in other countries, would enhance immunity in adolescence.
MeSH term(s)	Adolescent ; Antibodies, Bacterial/blood ; Antibodies, Viral/blood ; Antibody Formation ; Child ; Child, Preschool ; Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage ; Diphtheria-Tetanus-Pertussis Vaccine/therapeutic use ; Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage ; Diphtheria-Tetanus-acellular Pertussis Vaccines/therapeutic use ; Female ; Follow-Up Studies ; Humans ; Immunization, Secondary ; Kinetics ; Male ; Poliovirus Vaccine, Inactivated/administration & dosage ; Poliovirus Vaccine, Inactivated/therapeutic use ; Poliovirus Vaccine, Oral/administration & dosage ; Poliovirus Vaccine, Oral/therapeutic use ; Toxoids/immunology ; United Kingdom ; Vaccines, Combined/administration & dosage ; Vaccines, Combined/therapeutic use
Chemical Substances	Antibodies, Bacterial ; Antibodies, Viral ; DTPP vaccine ; Diphtheria-Tetanus-Pertussis Vaccine ; Diphtheria-Tetanus-acellular Pertussis Vaccines ; Poliovirus Vaccine, Inactivated ; Poliovirus Vaccine, Oral ; Toxoids ; Vaccines, Combined ; adacel ; pertussis toxoid
Language	English
Publishing date	2016-07-29
Publishing country	Netherlands
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2016.06.051
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Article ; Online: Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged ≥50 years: a randomised non-inferiority clinical trial.

Diez-Domingo, Javier / Weinke, Thomas / Garcia de Lomas, Juan / Meyer, Claudius U / Bertrand, Isabelle / Eymin, Cécile / Thomas, Stéphane / Sadorge, Christine

Vaccine

2015 Volume 33, Issue 6, Page(s) 789–795

Abstract: Zostavax(®) is a live, attenuated varicella zoster virus (VZV) vaccine developed specifically for the prevention of HZ and PHN in individuals aged ≥50 years. During the clinical development of Zostavax, which was mainly in the US, the vaccine was ... ...

Abstract	Zostavax(®) is a live, attenuated varicella zoster virus (VZV) vaccine developed specifically for the prevention of HZ and PHN in individuals aged ≥50 years. During the clinical development of Zostavax, which was mainly in the US, the vaccine was administrated by the subcutaneous (SC) route. In Europe, many healthcare professionals prefer administering vaccines by the intramuscular (IM) route. This was an open-label, randomised trial conducted in 354 subjects aged ≥50 years. The primary objectives were to demonstrate that IM administration is both non-inferior to SC administration in terms of 4-week post-vaccination geometric mean titres (GMTs), and elicits an acceptable geometric mean fold-rise (GMFR) of antibody titres measured by glycoprotein enzyme-linked immunosorbent assay. Pre-specified non-inferiority was set as the lower bound of the 95% confidence interval (CI) of the GMT ratio (IM/SC) being >0.67. An acceptable GMFR for the IM route was pre-specified as the lower bound of its 95% CI being >1.4. Description of the VZV immune response using the interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay and of the safety were secondary objectives. Participants were randomised to IM or SC administration (1:1). The baseline demographics were comparable between groups; mean age: 62.6 years (range: 50.0-90.5). The primary immunogenicity objectives were met (per protocol analysis): GMT ratio (IM/SC): 1.05 (95% CI: 0.93-1.18); GMFR: 2.7 (2.4-3.0). VZV immune response using IFN-γ ELISPOT were comparable between groups. Frequencies of systemic adverse events were comparable between groups. Injection-site reactions were less frequent with IM than SC route: erythema (15.9% versus 52.5%), pain (25.6% versus 39.5%) and swelling (13.6% versus 37.3%), respectively. In adults aged ≥50 years, IM administration of Zostavax elicited similar immune responses to SC administration and was well tolerated, with fewer injection-site reactions than with SC administration.
MeSH term(s)	Aged ; Aged, 80 and over ; Antibodies, Viral/blood ; Edema/etiology ; Edema/physiopathology ; Enzyme-Linked Immunospot Assay ; Erythema/etiology ; Erythema/physiopathology ; Female ; Herpes Zoster/blood ; Herpes Zoster/immunology ; Herpes Zoster/prevention & control ; Herpes Zoster Vaccine/administration & dosage ; Herpes Zoster Vaccine/adverse effects ; Herpes Zoster Vaccine/immunology ; Herpesvirus 3, Human/immunology ; Humans ; Injections, Intramuscular ; Injections, Subcutaneous ; Interferon-gamma/blood ; Male ; Middle Aged ; Pain/etiology ; Pain/physiopathology ; Vaccination ; Vaccines, Attenuated
Chemical Substances	Antibodies, Viral ; Herpes Zoster Vaccine ; Vaccines, Attenuated ; Interferon-gamma (82115-62-6)
Language	English
Publishing date	2015-02-04
Publishing country	Netherlands
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2014.12.024
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Article ; Online: Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS (®)) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio (®)) given as a booster dose at 6 years of age.

Gajdos, Vincent / Soubeyrand, Benoit / Vidor, Emmanuel / Richard, Patrick / Boyer, Julie / Sadorge, Christine / Fiquet, Anne

Human vaccines

2011 Volume 7, Issue 5, Page(s) 549–556

Abstract: This randomized, comparative, phase-IIIb study conducted in France aimed to demonstrate whether seroprotection against diphtheria, tetanus and poliomyelitis 1 month after a single dose of REVAXIS (low-dose diphtheria) is non-inferior to seroprotection 1 ... ...

Abstract	This randomized, comparative, phase-IIIb study conducted in France aimed to demonstrate whether seroprotection against diphtheria, tetanus and poliomyelitis 1 month after a single dose of REVAXIS (low-dose diphtheria) is non-inferior to seroprotection 1 month after a single dose of DT Polio (standard-dose diphtheria), both vaccines being given as a second booster to healthy children at 6 years of age. Children were randomly assigned to receive a single intramuscular dose of REVAXIS or DT Polio. Primary endpoints were the 1-month post-booster seroprotection rates for diphtheria, tetanus and poliovirus type-1, -2 and -3 antigens. Secondary endpoints were immunogenicity and safety observations. Of 788 children screened, 760 were randomized: REVAXIS group, 384 children; DT Polio group, 376 children. No relevant difference in demographic characteristics at baseline was observed between REVAXIS and DT Polio groups. Non-inferiority of REVAXIS compared with DT Polio for seroprotection was demonstrated against diphtheria (respectively 98.6% and 99.3%), tetanus (respectively 99.6% and 100%), and poliovirus antigens (100% for each types in both groups). No allergic reactions to REVAXIS were reported. A benefit/risk ratio in favor of REVAXIS was suggested by the trend towards a better tolerability of REVAXIS compared with DT Polio regarding the rate of severe solicited injection-site reactions. The results support the use of REVAXIS as a booster at 6 years of age in infants who previously received a three-dose primary series within the first 6 months of life and a first booster including diphtheria, tetanus and poliovirus vaccine(s) given before 2 years of age.
MeSH term(s)	Child ; Diphtheria/prevention & control ; Diphtheria Toxoid/administration & dosage ; Diphtheria Toxoid/adverse effects ; Diphtheria Toxoid/immunology ; Female ; France ; Humans ; Hypersensitivity ; Immunization, Secondary/adverse effects ; Immunization, Secondary/methods ; Incidence ; Injections, Intramuscular ; Male ; Poliomyelitis/prevention & control ; Poliovirus Vaccines/administration & dosage ; Poliovirus Vaccines/adverse effects ; Poliovirus Vaccines/immunology ; Skin Diseases/chemically induced ; Tetanus/prevention & control ; Tetanus Toxoid/administration & dosage ; Tetanus Toxoid/adverse effects ; Tetanus Toxoid/immunology ; Vaccines, Combined/administration & dosage ; Vaccines, Combined/adverse effects ; Vaccines, Combined/immunology
Chemical Substances	DTPolio vaccine ; Diphtheria Toxoid ; Poliovirus Vaccines ; Tetanus Toxoid ; Vaccines, Combined
Language	English
Publishing date	2011-05-01
Publishing country	United States
Document type	Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	1554-8619
ISSN (online)	1554-8619
DOI	10.4161/hv.7.5.14982
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Immunogenicity and safety of a live attenuated shingles (herpes zoster) vaccine (Zostavax®) in individuals aged ≥ 70 years: a randomized study of a single dose vs. two different two-dose schedules.

Vesikari, Timo / Hardt, Roland / Rümke, Hans C / Icardi, Giancarlo / Montero, Jordi / Thomas, Stéphane / Sadorge, Christine / Fiquet, Anne

Human vaccines & immunotherapeutics

2013 Volume 9, Issue 4, Page(s) 858–864

Abstract: Disease protection provided by herpes zoster (HZ) vaccination tends to reduce as age increases. This study was designed to ascertain whether a second dose of the HZ vaccine, Zostavax(®), would increase varicella zoster virus (VZV)-specific immune ... ...

Abstract	Disease protection provided by herpes zoster (HZ) vaccination tends to reduce as age increases. This study was designed to ascertain whether a second dose of the HZ vaccine, Zostavax(®), would increase varicella zoster virus (VZV)-specific immune response among individuals aged ≥ 70 y. Individuals aged ≥ 70 y were randomized to receive HZ vaccine in one of three schedules: a single dose (0.65 mL), two doses at 0 and 1 mo, or two doses at 0 and 3 mo. VZV antibody titers were measured at baseline, 4 weeks after each vaccine dose, and 12 mo after the last dose. In total, 759 participants (mean age 76.1 y) were randomized to receive vaccination. Antibody responses were similar after a single dose or two doses of HZ vaccine [post-dose 2/post-dose 1 geometric mean titer (GMT) ratios for the 1-mo or 3-mo schedules were 1.11, 95% confidence interval (CI) 1.02-1.22 and 0.78, 95% CI 0.73-0.85], respectively). The 12-mo post-dose 2/12-mo post-dose 1 GMT ratio was similar for the 1-mo schedule and for the 3-mo schedule (1.06, 95% CI 0.96-1.17 and 1.08, 95% CI 0.98-1.19, respectively). Similar immune responses were observed in participants aged 70-79 y and those aged ≥ 80 y. HZ vaccine was generally well tolerated, with no evidence of increased adverse event incidence after the second dose with either schedule. Compared with a single-dose regimen, two-dose vaccination did not increase VZV antibody responses among individuals aged ≥ 70 y. Antibody persistence after 12 mo was similar with all three schedules.
MeSH term(s)	Aged ; Aged, 80 and over ; Antibodies, Viral/blood ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/pathology ; Female ; Herpes Zoster/prevention & control ; Herpes Zoster Vaccine/administration & dosage ; Herpes Zoster Vaccine/adverse effects ; Herpes Zoster Vaccine/immunology ; Humans ; Longitudinal Studies ; Male ; Vaccination/adverse effects ; Vaccination/methods
Chemical Substances	Antibodies, Viral ; Herpes Zoster Vaccine
Language	English
Publishing date	2013-01-14
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2664176-8
ISSN	2164-554X ; 2164-5515
ISSN (online)	2164-554X
ISSN	2164-5515
DOI	10.4161/hv.23412
Database	MEDical Literature Analysis and Retrieval System OnLINE

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