NCT00980850 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Andrews NJ, Walker WT, Finn A, Heath PT, Collinson AC, Pollard AJ, Snape MD, Faust SN, Waight PA, Hoschler K, Sheasby L, Waddington C, Kerridge S, Chalk J, Reiner A, John T, Fletcher M, Allen R, Fineman N, Wilkins S, Casey M, Michaelis L, Oeser C, Okike I, Ladhani S, Miller E
Predictors of immune response and reactogenicity to AS03B-adjuvanted split virion and non-adjuvanted whole virion H1N1 (2009) pandemic influenza vaccines. Vaccine. 2011 Oct 19;29(45):7913-9. doi: 10.1016/j.vaccine.2011.08.076. Epub 2011 Aug 27.
Waddington C, Andrews N, Hoschler K, Walker W, Oeser C, Reiner A, John T, Wilkins S, Casey M, Eccleston P, Allen R, Okike I, Ladhani S, Sheasby E, Waight P, Collinson A, Heath P, Finn A, Faust S, Snape M, Miller E, Pollard A
Open-label, randomised, parallel-group, multicentre study to evaluate the safety, tolerability and immunogenicity of an AS03(B)/oil-in-water emulsion-adjuvanted (AS03(B)) split-virion versus non-adjuvanted whole-virion H1N1 influenza vaccine in UK children 6 months to 12 years of age. Health Technol Assess. 2010 Oct;14(46):1-130. doi: 10.3310/hta14460-01.
Waddington CS, Walker WT, Oeser C, Reiner A, John T, Wilkins S, Casey M, Eccleston PE, Allen RJ, Okike I, Ladhani S, Sheasby E, Hoschler K, Andrews N, Waight P, Collinson AC, Heath PT, Finn A, Faust SN, Snape MD, Miller E, Pollard AJ
Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre study. BMJ. 2010 May 27;340:c2649. doi: 10.1136/bmj.c2649.

Open Label, Randomized, Parallel-Group, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of Baxter H1N1 Vaccine and GlaxoSmithKline H1N1 Vaccine in Children 6 Months to 12 Years of Age

Details for clinical trial NCT00980850

Clinical trial NCT00980850 - References