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:
No DOI assigned. To request one pleaselog in.
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
Would the subject be willing to participate in a follow-up study?
If subject would not be willing to participate in a follow-up study, specify the reason
Study conclusion
Has the code been broken?
Did any elimination criteria become applicable during the study?
Has the subject dropped out of the study?
If subject dropped out, please mark the one most appropriate category for drop out
Was the subject in good condition at date of last contact?
Investigator signature
Tracking Document Safety Follow-Up
Follow-up
Tracking Document Safety Follow-Up
Did the subject experience any SAE(s) since the last contact?
Serious adverse event safety follow-up - Administrative
Serious adverse event safety follow-up
Serious adverse event
Subject Demography - Gende
SAE - Intensity
In your opinion, did the vaccine possibly contribute to the SAE
SAE - Other possible contributors
SAE - Outcome
SAE - Action taken with respect to Study Vaccine
SAE - Events after further vaccination
Specify criteria for considering this as a Serious Adverse Event
If SAE resulted in death, was autopsy performed?
Other events (not SAE) to be reported in the same way
Was subject withdrawn due to this specific SAE?
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
Condition still present?
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