Evidence for co-administration with other vaccines | ||||||
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STUDY DETAILS | SUMMARY | |||||
Study | Vaccine | Study Design | Participants | Summary of Key Findings | Level of Evidence | Quality |
HPV018 | Cervarix™ | Randomized, open, multicentre study To compare vaccine co-administered with Boostrix® vaccine (Tdap) and/or Menactra™ vaccine (MCV4) to administration of these vaccines alone |
Females 11 to 18 years =1283 |
Criteria for non-inferiority were met for all of the co-primary immunogenicity variables assessing co-administration of Tdap with HPV vaccine and MCV4 with HPV vaccine one month post-vaccination During the 30-day follow-up period after vaccination, unsolicited adverse events were reported by 118 (54.9%) subjects in the HPV Group, 108 (50.9%) in the HPV + Tdap/ MCV4 Group, 121 (56.5%) in the HPV + MCV4/ Tdap Group, 119 (55.6%) in the HPV + MCV4+ Tdap, 122 (57.0%) in the Tdap /HPV Group and 127 (59.3%) in the MCV4/HPV Group. |
Level I | Assessment pending peer-reviewed publication |
HPV026 (Leroux-Roels et al., 2011) | Cervarix™ | Randomized, controlled, open-label study To assess immunogenicity and safety of the hepatitis B vaccine given in an accelerated schedule co-administered with Cervarix™ |
Females 20 to 25 years n=152 |
One month after the third dose of hepatitis B vaccine, hepatitis B seroprotection rates (titer of >10 mIU/ml) were 96.4% (CI, 87.5 to 99.6) and 96.9% (CI, 89.2 to 99.6) in the HepB_HPV and HepB groups, respectively, in women initially seronegative for anti-hepatitis B surface antigen (HBs) and anti-hepatitis B core antigen (HBc). Corresponding GMTs of anti-HBs antibodies were 60.2 mIU/ml (CI, 40.0 to 90.5) and 71.3 mIU/ml (CI, 53.9 to 94.3). Anti-HBs antibody titers rose substantially after the fourth dose of hepatitis B vaccine. All women initially seronegative for anti-HPV-16 and anti-HPV-18 antibodies seroconverted after the second HPV-16/18 vaccine dose and remained seropositive up to 1 month after the third dose. Both vaccines were generally well tolerated, with no difference in reactogenicity between groups. |
Level I | Good |