Table 5.
Immunogenicity bridging studies.
Study | Vaccine | Study Groups/Age years (N) | Serologic Assay | % Sero-conversiona | Major Conclusions* |
---|---|---|---|---|---|
Reisinger KS et al. 2007 [12] | Gardasil® | Boys: 9-16 (567) | cLIA | ≥99.5 for all types | GMTs for boys non-inferior to those in girls |
Girls: 9-15 (617) | ≥99.6 for all types | Boys GMT 1.1-1.5 fold higher than girls | |||
Block SL et al. 2006 [26] | Gardasil® | Boys: 10-15 (510) | cLIA | ≥99.7 for all types | GMTs for boys and girls non-inferior to those in women |
Girls: 10-15 (506) | 100 for all types | Boys GMT 1.8-2.7 fold higher than women’s | |||
Women: 16-23 (513) | ≥99.1 for all types | Girls GMT 1.7-2.0 fold higher than women’s | |||
Pedersen C et al. 2007 [27] | Cervarix® | Girls: 10-14 (158) | ELISA | 100 for both types | GMTs for girls non-inferior to those in women |
Women: 15-25 (458) | 100 for both types | Girl’s GMT 2.1-2 fold higher than women’s |