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

scientific article

Template protocol for clinical trials investigating vaccines--focus on safety elements is …
instance of (P31):
scholarly articleQ13442814

External links are
P356DOI10.1016/J.VACCINE.2013.02.041
P932PMC publication ID4586124
P698PubMed publication ID23499603
P5875ResearchGate publication ID236054003

P50authorVasee MoorthyQ28955405
Johan VekemansQ28955487
David R. NalinQ5237914
Ranjan RamasamyQ7293102
Egeruan B ImoukhuedeQ37382456
Sonali KochharQ55473907
Jan BonhoefferQ56394692
Robert T. ChenQ86371125
Mamodikoe MakheneQ98710769
Ulrich HeiningerQ102068710
Ali KhamesipourQ114412337
Rebecca PrevotsQ114412338
P2093author name stringVirginia Wong
Khalequz Zaman
Soju Chang
Grace Aldrovandi
James D Heffelfinger
Rohini Fernandopulle
Elissa Malkin
Sarah Sellers
Novilia S Bachtiar
Karen L Goldenthal
Shah Hossain
Pam Wilson
Eng-Soon Chan
Brighton Collaboration Clinical Trial Protocol Working Group
Indira Jevaji
Kenneth B Walker
P2860cites workGuillain–Barré syndrome and Fisher syndrome: Case definitions and guidelines for collection, analysis, and presentation of immunization safety dataQ22251433
Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentationQ30540815
Persistent crying in infants and children as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentationQ30540817
Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentationQ30890095
Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentationQ30890102
Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentationQ30890134
Fatigue: case definition and guidelines for collection, analysis, and presentation of immunization safety dataQ31107779
Rash including mucosal involvement: case definition and guidelines for collection, analysis, and presentation of immunization safety dataQ31107914
Unexplained sudden death, including sudden infant death syndrome (SIDS), in the first and second years of life: case definition and guidelines for collection, analysis, and presentation of immunization safety dataQ31108130
Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety dataQ31109981
Thrombocytopenia: case definition and guidelines for collection, analysis, and presentation of immunization safety dataQ31112245
Robust take following exposure to vaccinia virus: case definition and guidelines of data collection, analysis, and presentation of immunization safety dataQ31114155
Generalized vaccinia as an adverse event following exposure to vaccinia virus: case definition and guidelines for data collection, analysis, and presentation of immunization safety dataQ31114158
Inadvertent inoculation as an adverse event following exposure to vaccinia virus: case definition and guidelines for data collection, analysis, and presentation of immunization safety dataQ31114161
Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization in early childhood: case definition and guidelines for data collection, analysis, and presentationQ31114165
Abscess at injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety dataQ31114324
Swelling at or near injection site: case definition and guidelines for collection, analysis and presentation of immunization safety dataQ31114573
Cellulitis at injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety dataQ31114574
Induration at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety dataQ31114967
Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): case definitions and guidelines for collection, analysis, and presentation of immunization safety dataQ31115845
Aseptic meningitis: case definition and guidelines for collection, analysis and presentation of immunization safety dataQ31116047
Immunological outcomes of new tuberculosis vaccine trials: WHO panel recommendationsQ33348739
A local reaction at or near injection site: case definition and guidelines for collection, analysis, and presentation of immunization safety dataQ33379317
Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studiesQ33389704
Diarrhea: case definition and guidelines for collection, analysis, and presentation of immunization safety dataQ33763060
MALVAC 2008: Measures of efficacy of malaria vaccines in phase 2b and phase 3 trials--scientific, regulatory and public health perspectivesQ42605516
Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultationQ47836020
The development of standardized case definitions and guidelines for adverse events following immunizationQ80074697
P433issue47
P407language of work or nameEnglishQ1860
P304page(s)5602-5620
P577publication date2013-03-13
P1433published inVaccineQ7907941
P1476titleTemplate protocol for clinical trials investigating vaccines--focus on safety elements
P478volume31

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cites work (P2860)
Q90249371Effect of alcohol skin cleansing on vaccination-associated infections and local skin reactions: a randomized controlled trial
Q26782451Enhancing vaccine safety capacity globally: A lifecycle perspective
Q37477687Guidance for the collection of case report form variables to assess safety in clinical trials of vaccines in pregnancy
Q26250281Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women
Q38867783Incidence and types of adverse events during mass vaccination campaign with the meningococcal a conjugate vaccine (MENAFRIVAC™) in Cameroon.
Q40827238Mutagenic Potential ofBos taurus Papillomavirus Type 1 E6 Recombinant Protein: First Description.
Q89595553PRIMVAC vaccine adjuvanted with Alhydrogel or GLA-SE to prevent placental malaria: a first-in-human, randomised, double-blind, placebo-controlled study
Q57472233Standardized guinea pig model for Q fever vaccine reactogenicity
Q42372774TBVAC2020: Advancing Tuberculosis Vaccines from Discovery to Clinical Development
Q36057541The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG).