Table 1.
Study design features of safety of HPV vaccines.
| Author, year | Local | Follow-up | Inclusion criteria | Vaccine type | Control | Age interval | n |
|---|---|---|---|---|---|---|---|
| Harper, 2004 | Multicenter | 27 months | No more than six sexual partners; no history of an abnormal Pap test or ablative or excisional treatment of the cervix; no ongoing treatment for external condylomata; cytologically negative, seronegative for HPV-16 and HPV-18 antibodies by ELISA, and HPV-DNA-negative by PCR for 14 high-risk HPV types no more than 90 days before study entry. | 16/18 | Aluminum hydroxide. | 15–25 | 1113 |
| Bhatla, 2010 | India | 7 months | Nonpregnant or planning to become pregnant; not taking any other investigational products or steroids. | 16/18 | Aluminum hydroxide. | 18–35 | 354 |
| Kim, 2010 | Korea | 7 months | Nonpregnant or planning to become pregnant; not taking any other investigational products or immune-modifying drugs and not breastfeeding during the study. | 16/18 | Aluminum hydroxide. | 10–14 | 321 |
| Medina, 2010 | Multicenter | 14 months | Healthy girls. | 16/18 | Hepatitis A virus vaccine | 12+- | 2067 |
| Ngan, 2010 | Hong Kong | 7 months | Healthy women aged 18–35 years. | 16/18 | Aluminum hydroxide. | 18–35 | 294 |
| Kim, 2011 | Korea | 7 months | Nonpregnant and agreed to use adequate contraceptive precautions over the vaccination period. | 16/18 | Aluminum hydroxide. | 15–25 | 225 |
| Szarewski, 2011 | Multicenter | 4 years | Nonpregnant; no more than six lifetime sexual partners before enrolment; agreed to use adequate contraception over the vaccination period and had an intact cervix. | 16/18 | Hepatitis A virus vaccine. | 15–25 | 18,644 |
| Khatun, 2012 | Bangladesh | 16 months | Unmarried and sexually unexposed. | 16/18 | No vaccine. | 9–13 | 67 |
| Reisinger, 2007 | Multicenter | 18 months | Nonpregnant; must not have had a febrile illness (fever more than 37.8 °C [100 °F]) at vaccination. | 6/11/16/18 | Aluminum hydroxide. | 9–15 | 1781 |
| Kang, 2008 | Korea | 7 months | Nonpregnant; must not have had a febrile illness (fever more than 37.8 °C [100 °F]) at vaccination; subjects aged 9–15 years: no sexual experience before and no plan to have sexual experience during the study period; subjects aged 16–23: less than four male and/or female sexual partners at enrollment and were required to use effective contraception during the study period. Exclusion criteria: enrollment in studies of other investigational agents; any HPV vaccination, history of allergy to vaccine compound; thrombocytopenia; history of vaccination within 14 days from enrollment; receipt of blood or blood-derived products within the 6 months preceding injection, and immunosuppression. Subjects aged 16–23 years of age: have not had a prior Pap test showing a squamous intraepithelial lesion or worse and/or a biopsy indicating CIN or worse. | 6/11/16/18 | Same adjuvant. | 9–23 | 176 |
| Lazcano-Ponce, 2009 | Mexico | 48 months | Nonpregnant; four or less sexual partners during their lifetime. | 6/11/16/18 | Aluminum hydroxide. | 18–23 | 679 |
| Muñoz, 2009 | Multicenter | 48 months | Nonpregnant; no history of genital warts or present or past; not immunocompromised (HIV or other), not undergone hysterectomy; required to use effective contraception until month 7 of the study. Women with any previous cervical surgical procedure and those having undergone a cervical biopsy within the past 5 years were excluded. | 6/11/16/18 | Aluminum hydroxide. | 24–45 | 3819 |