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Safety profile of t...
Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials
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- López-Fauqued, M. (author)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium
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- Campora, L. (author)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium
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- Delannois, F. (author)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium
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show more...
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- El Idrissi, M. (author)
- GSK, Rixensart, BEL,GSK, Rixensart, Belgium
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- Oostvogels, L. (author)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium;CureVac AG, Tubingen, Germany
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- De Looze, F. J. (author)
- University of Queensland, AUS,AusTrials Pty Ltd, Sherwood, Qld, Australia;Univ Queensland, Sch Med, Brisbane, Qld, Australia
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- Diez-Domingo, J. (author)
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica, ESP,Fdn Fomento Invest Sanitaria & Biomed, Vaccine Res Unit, Valencia, Spain
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- Heineman, T. C. (author)
- GSK, King Of Prussia, PA USA;Halozyme Therapeut, San Diego, CA USA,Hosp Clin San Carlos, Madrid, Spain
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- Lal, H. (author)
- GSK, King Of Prussia, PA USA;Pfizer Vaccine Inc, Collegeville, PA USA
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- McElhaney, J. E. (author)
- ealth Sciences North Research Institute, CAN,Hlth Sci North Res Inst, Sudbury, ON, Canada,GSK, Brussels, Belgium
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- McNeil, S. A. (author)
- Dalhousie University, CAN,Dalhousie Univ, Canadian Ctr Vaccinol, Halifax, NS, Canada;Dalhousie Univ, IWK Hlth Ctr, Halifax, NS, Canada;Dalhousie Univ, Nova Scotia Hlth Author, Halifax, NS, Canada,Univ Tampere, Jarvenpaa Vaccine Clin, Tampere, Finland,University of Tampere, FIN
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- Yeo, W. (author)
- University of Wollongong, AUS,Univ Wollongong, Sch Med, Wollongong, NSW, Australia
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- Tavares-Da-Silva, F. (author)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium
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- Ahonen, A. (author)
- University of Tampere, FIN
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- Avelino-Silva, T. J. (author)
- University of São Paulo, BRA,Univ Sao Paulo, Sch Med, Sao Paulo, Brazil
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- Barba-Gomez, J. F. (author)
- Instituto Dermatológico de Jalisco, MEX,Inst Dermatol Jalisco, Guadalajara, Jalisco, Mexico
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- Sanmartin Berglund, Johan, Professor (author)
- Blekinge Tekniska Högskola,Institutionen för hälsa,Blekinge Inst Technol, Karlskrona, Sweden
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- Brotons Cuixart, Carlos (author)
- EAP Sardenya, Barcelona, Spain
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- Chlibek, Roman (author)
- Univ Def, Fac Mil Hlth Sci, Brno, Czech Republic
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- Choi, Won Suk (author)
- Korea Univ, Coll Med, Seoul, South Korea
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- Cunningham, Anthony L. (author)
- Univ Sydney, Westmead Inst Med Res, Sydney, NSW, Australia
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- Desole, Maria Guiseppina (author)
- Serv Igiene Pubbl, Sassari, Italy
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- Eizenberg, Peter (author)
- Doctors Ivanhoe, Ivanhoe, Australia
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- Esen, Meral (author)
- Univ Clin Tubingen, Inst Tropenmed, Tubingen, Germany
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- Gervais, Pierre (author)
- Q&T Res Sherbrooke, Sherbrooke, PQ, Canada
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- Ghesquiere, Wayne (author)
- Univ British Columbia, Vancouver, BC, Canada
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- Godeaux, Olivier (author)
- GSK, Brussels, Belgium
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- Gorfinkel, Iris (author)
- York Univ, N York, ON, Canada
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- Hui, David Shu Cheong (author)
- Prince Wales Hosp, Hong Kong, Peoples R China
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- Hwang, Shinn-Jang (author)
- Taipei Vet Gen Hosp, Taipei, Taiwan;Natl Yang Ming Univ, Sch Med, Taipei, Taiwan
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- Korhonen, Tiina (author)
- Univ Tampere, Sch Med, Vaccine Res Ctr, Tampere, Finland
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- Kovac, Martina (author)
- GSK, New York, NY USA
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- Ledent, Edouard (author)
- GSK, Rixensart, Belgium
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- Leung, Edward (author)
- Hong Kong Assoc Gerontol, Hong Kong, Peoples R China
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- Levin, Myron J. (author)
- Univ Colorado, Anschutz Med Campus, Aurora, CO USA
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- Narejos Perez, Silvia (author)
- CAP Centelles, Centelles, Spain
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- Neto, Jose Luiz (author)
- Inst AZ Pesquisa & Ensino, Curitiba, Parana, Brazil
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- Pauksen, Karlis (author)
- Uppsala universitet,Infektionssjukdomar
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- Poder, Airi (author)
- Kliiniliste Uuringute Keskus, Tartu, Estonia
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- Rodriguez de la Pinta, Maria Luisa (author)
- Hosp Puerta de Hierro, Madrid, Spain
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- Rombo, Lars (author)
- Uppsala universitet,Centrum för klinisk forskning i Sörmland (CKFD)
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- Schwarz, Tino F. (author)
- Standort Juliusspital, Wurzburg, Germany
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- Smetana, Jan (author)
- Univ Def, Fac Mil Hlth Sci, Brno, Czech Republic
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- Staniscia, Tommaso (author)
- Univ G dAnnunzio, Chieti, Italy
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- Tinoco, Juan Carlos (author)
- Hosp Gen Durango, Durango, Mexico
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- Toma, Azhar (author)
- Manna Res, Toronto, ON, Canada
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- Vastiau, Ilse (author)
- GSK, Ave Fleming 20, B-1300 Wavre, Belgium
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- Vesikari, Timo (author)
- Univ Tampere, Tampere, Finland
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- Volpi, Antonio (author)
- AO Univ Policlin Tor Vergata, Rome, Italy
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- Watanabe, Daisuke (author)
- Kobe Univ, Grad Sch Med, Kobe, Hyogo, Japan
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- Weckx, Lily Yin (author)
- Univ Fed Sao Paulo, Sao Paulo, Brazil
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- Zahaf, Toufik (author)
- GSK, Brussels, Belgium
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(creator_code:org_t)
- Elsevier Ltd, 2019
- 2019
- English.
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In: Vaccine. - : Elsevier Ltd. - 0264-410X .- 1873-2518. ; 37:18, s. 2482-2493
- Related links:
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https://doi.org/10.1...
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https://bth.diva-por... (primary) (Raw object)
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV. © 2019 GlaxoSmithKline Biologicals SA
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Allmänmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- General Practice (hsv//eng)
Keyword
- Reactogenicity
- Safety
- Vaccine
- Varicella-zoster virus
- placebo
- varicella zoster vaccine
- acute kidney failure
- adult
- age distribution
- aged
- alopecia areata
- aortic stenosis
- arthralgia
- Article
- atrial fibrillation
- autoimmune pancreatitis
- autoimmune thyroiditis
- backache
- brain infarction
- cardiogenic shock
- cardiopulmonary insufficiency
- celiac disease
- cerebrovascular accident
- chill
- chronic gastritis
- chronic obstructive lung disease
- clinical evaluation
- cohort analysis
- controlled study
- coughing
- Crohn disease
- disease course
- dizziness
- drug efficacy
- drug safety
- erythema nodosum
- facial nerve paralysis
- fatigue
- female
- fever
- fibrosing alveolitis
- follow up
- glomerulonephritis
- Graves disease
- Guillain Barre syndrome
- headache
- heart atrium flutter
- heart failure
- heart infarction
- herpes zoster
- human
- idiopathic thrombocytopenic purpura
- immunoglobulin A nephropathy
- information processing
- injection site erythema
- injection site pain
- injection site pruritus
- injection site swelling
- injection site warmth
- insulin dependent diabetes mellitus
- lichen planus
- lung fibrosis
- lung tumor
- major clinical study
- malaise
- male
- mixed connective tissue disease
- multiple organ failure
- multiple sclerosis
- myalgia
- neuritis
- oropharynx pain
- pancreas carcinoma
- paraneoplastic neuropathy
- pemphigus
- phase 3 clinical trial
- pneumonia
- polyradiculoneuropathy
- population research
- priority journal
- psoriasis
- psoriatic arthritis
- race
- radiculitis
- randomized controlled trial
- Raynaud phenomenon
- respiratory failure
- retina detachment
- rheumatic polymyalgia
- rheumatoid arthritis
- rhinopharyngitis
- sepsis
- septic shock
- sex ratio
- single blind procedure
- spondyloarthropathy
- supraventricular tachycardia
- syndrome CREST
- systemic juvenile idiopathic arthritis
- systemic lupus erythematosus
- tachycardia
- temporal arteritis
- trigeminal nerve disease
- trigeminus neuralgia
- ulcerative colitis
- upper respiratory tract infection
- uveitis
- vaccination
- vitiligo
Publication and Content Type
- ref (subject category)
- art (subject category)
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Vaccine
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To the university's database
- By the author/editor
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López-Fauqued, M ...
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Campora, L.
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Delannois, F.
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El Idrissi, M.
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Oostvogels, L.
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De Looze, F. J.
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show more...
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Diez-Domingo, J.
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Heineman, T. C.
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Lal, H.
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McElhaney, J. E.
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McNeil, S. A.
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Yeo, W.
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Tavares-Da-Silva ...
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Ahonen, A.
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Avelino-Silva, T ...
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Barba-Gomez, J. ...
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Sanmartin Berglu ...
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Brotons Cuixart, ...
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Chlibek, Roman
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Choi, Won Suk
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Cunningham, Anth ...
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Desole, Maria Gu ...
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Eizenberg, Peter
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Esen, Meral
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Gervais, Pierre
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Ghesquiere, Wayn ...
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Godeaux, Olivier
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Gorfinkel, Iris
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Hui, David Shu C ...
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Hwang, Shinn-Jan ...
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Korhonen, Tiina
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Kovac, Martina
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Ledent, Edouard
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Leung, Edward
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Levin, Myron J.
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Narejos Perez, S ...
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Neto, Jose Luiz
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Pauksen, Karlis
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Poder, Airi
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Rodriguez de la ...
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Rombo, Lars
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Schwarz, Tino F.
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Smetana, Jan
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Staniscia, Tomma ...
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Tinoco, Juan Car ...
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Toma, Azhar
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Vastiau, Ilse
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Vesikari, Timo
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Volpi, Antonio
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Watanabe, Daisuk ...
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Weckx, Lily Yin
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Zahaf, Toufik
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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and Public Health Gl ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and General Practice
- Articles in the publication
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Vaccine
- By the university
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Blekinge Institute of Technology
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Uppsala University