Informative Speech On Gardasil
Title: Phasing into Gardasil.
Specific Purpose: To inform my audience of the phase III clinical trials and safety of Gardasil.
Central idea: In phase III clinical trials for Gardasil, efficacy and safety were the prime focuses addressed in the FUTURE I and FUTURE II trials.
Introduction:
Don’t you just hate it when the actual outcome is far from the desired result? Like in cooking or in sports. This can also be in drug development. As Mary Ann mentioned, Gardasil was not made in a day due to an extensive number of clinical trials to ensure that the vaccine does produce the desired result within safety measures. After my lengthy research on Gardasil, specifically in the phase III clinical trials that revolve around its safety and effectiveness, it gives me much hope and security as I myself have received this vaccine. I will be informing you today about two randomized, double …show more content…
FUTURE I was a study that began in 2001 to evaluate the efficacy and safety of the quadrivalent HPV for the use of reducing the incidence of HPV 6, 11, 16, 18 related external genital warts and prevention of cervical cancer in adolescent and young adult females.
A. Participants had to have had normal baseline pelvic examinations but were not prescreened for HPV prior to randomization.
B. Vaccine formulation or placebo was given intramuscularly at 0,2,and 6 months for the three-dose regimen.
C. Close safety monitoring was conducted:
1. A review of safety and complete physical examination and pap tests was completed 8 times during the study.
2. Serum for immunogenicity to determine if there is a capability of the production of an immune response was obtained on day 1 and 5 additional times.
D. The Gardasil group had 0 cases of cervical intraepithelial neoplasia grade 1 due to these HPV strains. However, of the placebo group there were 37 confirmed cases of CIN 1 recorded.
1. This allows us to conclude that Gardasil had a 100% observed efficacy in the FUTURE I study for CIN
Specific Purpose: To inform my audience of the phase III clinical trials and safety of Gardasil.
Central idea: In phase III clinical trials for Gardasil, efficacy and safety were the prime focuses addressed in the FUTURE I and FUTURE II trials.
Introduction:
Don’t you just hate it when the actual outcome is far from the desired result? Like in cooking or in sports. This can also be in drug development. As Mary Ann mentioned, Gardasil was not made in a day due to an extensive number of clinical trials to ensure that the vaccine does produce the desired result within safety measures. After my lengthy research on Gardasil, specifically in the phase III clinical trials that revolve around its safety and effectiveness, it gives me much hope and security as I myself have received this vaccine. I will be informing you today about two randomized, double …show more content…
FUTURE I was a study that began in 2001 to evaluate the efficacy and safety of the quadrivalent HPV for the use of reducing the incidence of HPV 6, 11, 16, 18 related external genital warts and prevention of cervical cancer in adolescent and young adult females.
A. Participants had to have had normal baseline pelvic examinations but were not prescreened for HPV prior to randomization.
B. Vaccine formulation or placebo was given intramuscularly at 0,2,and 6 months for the three-dose regimen.
C. Close safety monitoring was conducted:
1. A review of safety and complete physical examination and pap tests was completed 8 times during the study.
2. Serum for immunogenicity to determine if there is a capability of the production of an immune response was obtained on day 1 and 5 additional times.
D. The Gardasil group had 0 cases of cervical intraepithelial neoplasia grade 1 due to these HPV strains. However, of the placebo group there were 37 confirmed cases of CIN 1 recorded.
1. This allows us to conclude that Gardasil had a 100% observed efficacy in the FUTURE I study for CIN