Description:

Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

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Versions (1) ▾
  1. 10/17/19
Copyright Holder:
GlaxoSmithKline
Uploaded on:

October 17, 2019

DOI:
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License:
Creative Commons BY-NC 3.0
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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)

Follow-up-studies; Study conclusion; Investigator signature; Tracking Document Safety Follow-Up; Serious Adverse Event Safety Follow-Up

Administration
Follow-up studies
Study conclusion
Investigator signature
Tracking Document Safety Follow-Up
Tracking Document Safety Follow-Up
Serious adverse event safety follow-up - Administrative
Serious adverse event safety follow-up
Serious adverse event safety follow-up - Study vaccine information
Serious adverse event safety follow-up - Concomitant medication/ Vaccination that could have contributed to this SAE
Serious adverse event safety follow-up - Relevant intercurrent illness & medical history that could have contributed to this SAE
Serious adverse event safety follow-up - Drug(s) used to treat this SAE
Serious adverse event safety follow-up - Surgical treatment for this SAE
Serious adverse event safety follow-up - Description
Serious adverse event safety follow-up - Comments
Serious adverse event safety follow-up - Investigator signature