CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01001169
NCT01001169Phase 2Completed
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Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Japanese Children Aged 6 Months to 17 Years

GlaxoSmithKline·interventional·Posted Oct 23, 2009·Updated Aug 17, 2018

In Brief

A Phase 2 clinical trial evaluating GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A) for Influenza. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, using the same dosage as has been used in the H5N1 development program in Japanese children aged 10-17 years and an alternative dose in children aged 6 months to 9 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 23, 2009
Enrollment StartOct 1, 2009
Primary CompletionMay 17, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.7 years ago

Interventions

GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)biological

Two intramuscular injections