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Appendix C Suggested Design of Trials for Testing Malaria Vaccines in Nonimmune Adults Visiting Endemic Areas
Pages 96-98

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From page 96...
... Appendix C Suggested Design of Trials for Testing Malaria Vaccines in Nonimmune Adults Visiting Endemic Areas A total of three critical phase 3 trials of efficacy is envisioned. All three trials would be randomized (at the level of the individual subject)
From page 97...
... TRIALS IN THE PRESENCE OF CHEMOPROPHYLAXIS If the corroborating phase 3 trial not under chemoprophylaxis also yields positive results, it would be appropriate for the Military Infectious Diseases Research Program (MIDRP) Malaria Vaccine Program to undertake a much larger phase 3 trial with 10 times as many subjects in the
From page 98...
... 98 APPENDIX C vaccine and control groups, all of whom would be issued standard military chemoprophylaxis. Although subjects would be recommended to take chemoprophylaxis, there would be no systematic direct supervision of subjects taking their daily medication.


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