ID

41672

Description

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Contraindications to subsequent vaccination) should be filled out whenever a vaccination is due. Indications for deferral of vaccination: The following AEs constitute contraindications to administration of RTS,S/AS02D or RTS,S/AS01E at that point in time; if any one of these AEs occur at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. Absolute contraindications to further vaccination: The following AEs constitute absolute contraindications to further administration of RTS,S/AS02D or RTS,S/AS01E; if any of these AEs occur during the study, the subject must not receive additional doses of vaccine, but may continue other study procedures at the discretion of the investigator.

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Keywords

Versions (1)

1. 12/9/20 12/9/20 -

Copyright Holder

GlaxoSmithKline

Uploaded on

December 9, 2020

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