Figure 1.
Study profile. *By mistake, one participant in the vaccine group was given the control vaccine (the commercialized recombinant hepatitis E vaccine containing 30 μg of recombinant hepatitis E virus capsid protein absorbed to aluminum adjuvant) for dose 1, and two participants in the control group were given the test vaccine for dose 3. According to the protocol, these participants were retained in the randomly assigned group for efficacy analysis but were classified into the vaccine group for safety analysis. †Susceptible to infection by a relevant type of human papillomavirus (HPV) is defined as negative for the corresponding type of neutralizing antibody on day 0 and negative for the corresponding type of HPV DNA from day 0 through month 7. PPS-E = per-protocol set for the pathological endpoint; PPS-I = per-protocol set for the immune endpoint; PPS-P = per-protocol set for the immune persistence endpoint; PPS-PI = per-protocol set for the persistent infection endpoint.

Study profile. *By mistake, one participant in the vaccine group was given the control vaccine (the commercialized recombinant hepatitis E vaccine containing 30 μg of recombinant hepatitis E virus capsid protein absorbed to aluminum adjuvant) for dose 1, and two participants in the control group were given the test vaccine for dose 3. According to the protocol, these participants were retained in the randomly assigned group for efficacy analysis but were classified into the vaccine group for safety analysis. Susceptible to infection by a relevant type of human papillomavirus (HPV) is defined as negative for the corresponding type of neutralizing antibody on day 0 and negative for the corresponding type of HPV DNA from day 0 through month 7. PPS-E = per-protocol set for the pathological endpoint; PPS-I = per-protocol set for the immune endpoint; PPS-P = per-protocol set for the immune persistence endpoint; PPS-PI = per-protocol set for the persistent infection endpoint.

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