Template protocol for clinical trials investigating vaccines-Focus on safety elements

Vaccine

Volumn 31, Issue 47, 2013, Pages 5602-5620

  Bonhoeffer, Jan ^a   Imoukhuede, Egeruan B ^b   Aldrovandi, Grace ^c   Bachtiar, Novilia S ^d   Chan, Eng Soon ^d   Chang, Soju ^e   Chen, Robert T ^f   Fernandopulle, Rohini ^g   Goldenthal, Karen L ^h   Heffelfinger, James D ^f   Hossain, Shah ⁱ   Jevaji, Indira ^e   Khamesipour, Ali ^j   Kochhar, Sonali ^k   Makhene, Mamodikoe ^e   Malkin, Elissa ^l   Nalin, David ^m   Prevots, Rebecca ^d   Ramasamy, Ranjan ⁿ   Sellers, Sarah ^o   Vekemans, Johan ^p   Walker, Kenneth B ^q   Wilson, Pam ^r   Wong, Virginia ^s   Zaman, Khalequz ^t   Heininger, Ulrich ^a   more..

^a UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^b European Vaccine Initiative   (Germany)

^c CHILDREN S HOSPITAL LOS ANGELES   (United States)

^d Bio Farma ^*

^e NATIONAL INSTITUTES OF HEALTH   (United States)

^f CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^g UNIVERSITY OF COLOMBO   (Sri Lanka)

^h Independent Consultant   (United States)

ⁱ NATIONAL INSTITUTE OF COMMUNICABLE DISEASES   (India)

^j TEHRAN UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^k INTERNATIONAL AIDS VACCINE INITIATIVE   (United States)

^l MEDIMMUNE   (United States)

^m Consultant in vaccinology ^*  (United States)

ⁿ UNIVERSITI BRUNEI DARUSSALAM   (Brunei Darussalam)

^o Q Vigilance   (United States)

^p GSK   (Belgium)

^q PUBLIC HEALTH ENGLAND   (United Kingdom)

^r HARVARD CLINICAL RESEARCH INSTITUTE   (United States)

^s UNIVERSITY OF HONG KONG   (Hong Kong)

^t INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH   (Bangladesh)

more..

Author keywords

Clinical trial; Immunization; Protocol; Safety; Vaccine

Indexed keywords

VACCINE;

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); DECISION MAKING; DRUG ADMINISTRATION ROUTE; DRUG SAFETY; HUMAN; IMMUNIZATION; IMMUNOGENICITY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; STUDY DESIGN;

ADVERSE EVENT FOLLOWING IMMUNIZATION; AEFI; CASE REPORT FORM; CENTRAL SAFETY PHYSICIAN; CIOMS; CLINICAL TRIAL; COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES; CRF; CSP; DATA AND SAFETY MONITORING BOARD; DSMB; FDA; GCP; GOOD CLINICAL PRACTICE; ICF; ICH; IDMC; IEC; IMMUNIZATION; INDEPENDENT ETHICS COMMITTEE; INFORMED CONSENT FORM; INSTITUTIONAL REVIEW BOARD; INTERNATIONAL CONFERENCE ON HARMONIZATION; IRB; LMIC; LOCAL SAFETY MONITOR; LOW AND MIDDLE INCOME COUNTRY; LSM; NIH; PROTOCOL; SAE; SAFETY; SERIOUS ADVERSE EVENT; SOP; STANDARD OPERATION PROCEDURE; THE INDEPENDENT DATA MONITORING COMMITTEE; UNITED STATES FOOD AND DRUG ADMINISTRATION; UNITED STATES NATIONAL INSTITUTES OF HEALTH; VACCINE; WHO; WORLD HEALTH ORGANIZATION;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; HUMANS; VACCINES;

EID: 84886784476     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2013.02.041     Document Type: Article

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