. 2019 Jul 4;12:1951–1967. doi: 10.2147/IDR.S178381

Table 2.

Studies reporting efficacy of 9vHPV against HPV infection and associated diseases

Type of study	Primary endpoint	Number of participants and age	Study findings	References
Subgroup analyses of two Phase III RCTs	Efficacy, immunogenicity, and safety in Asian participants	Study 001: N=1717 (women, 16–26 years) Study 002: N=608 (boys and girls)	Per-protocol 9vHPV efficacy against HPV31, 33, 45, 52, and 58: Any grade cervical, vulva, and vaginal diseases: 100% (95% CI, 40.0–100) ≥6 months persistent infection: 95.8% (95% CI, 87.8–98.9) ≥12 months persistent infection: 93.9% (95% CI, 81.4–98.4)	44
Subgroup analyses of two Phase III RCTs	Efficacy, immunogenicity, and safety in Latin American participants	Study 001: N=4744 (women, 16–26 years) Study 002: N=568 (boys and girls)	Per-protocol 9vHPV efficacy against HPV31, 33, 45, 52, and 58 (Study 001): Any grade cervical, vulva, and vaginal diseases: 96.9% (95% CI, 89.2–99.5) ≥6 months persistent infection: 95.2% (95% CI, 92.7–97.0)	45
Phase III double-blind RCT	Vaccine efficacy against incidence of high-grade CIN, AIS, ICC, VIN, VaIN, and vaginal/vulva cancer related to HPV31, 33, 45, 52, and 58	N=14,215 (16–26 years) Follow up to 42 months for both groups, N=13,587; up to 60 months for 9vHPV group	Per-protocol 9vHPV efficacy against HPV31, 33, 45, 52, and 58: Any high-grade diseases: 96.7% (95% CI, 80.9–99.8) CIN and AIS: 96.3% (95% CI, 79.5–99.8) ≥6 months persistent infection: 96.0% (95% CI, 94.4–97.2) Per-protocol 9vHPV efficacy against HPV31, 33, 45, 52, and 58, 6 years post dose one: Any high-grade diseases: 97.4% (95% CI, 85.0–99.9) CIN and AIS: 98.2% (95% CI, 93.7–99.7) 12 months persistent infection: 96.7% (95% CI, 95.1–97.9) Similar incidence of CIN, VIN, ValN, and persistent infection related to HPV6, 11, 16, and 18 between 4vHPV and 9vHPV	42, 43

Type of study

Primary endpoint

Number of participants and age

Study findings

References

Subgroup analyses of two Phase III RCTs

Efficacy, immunogenicity, and safety in Asian participants

Study 001:
N=1717 (women, 16–26 years)
Study 002:
N=608 (boys and girls)

Per-protocol 9vHPV efficacy against HPV31, 33, 45, 52, and 58:

Any grade cervical, vulva, and vaginal diseases: 100% (95% CI, 40.0–100)
≥6 months persistent infection: 95.8% (95% CI, 87.8–98.9)
≥12 months persistent infection: 93.9% (95% CI, 81.4–98.4)

Subgroup analyses of two Phase III RCTs

Efficacy, immunogenicity, and safety in Latin American participants

Study 001:
N=4744 (women, 16–26 years)
Study 002:
N=568 (boys and girls)

Per-protocol 9vHPV efficacy against HPV31, 33, 45, 52, and 58 (Study 001):

Any grade cervical, vulva, and vaginal diseases: 96.9% (95% CI, 89.2–99.5)
≥6 months persistent infection: 95.2% (95% CI, 92.7–97.0)

Phase III
double-blind RCT

Vaccine efficacy against incidence of high-grade CIN, AIS, ICC, VIN, VaIN, and vaginal/vulva cancer related to HPV31, 33, 45, 52, and 58

N=14,215 (16–26 years)
Follow up to
42 months for both groups, N=13,587; up to
60 months
for 9vHPV group

Per-protocol 9vHPV efficacy against HPV31, 33, 45, 52, and 58:

Any high-grade diseases: 96.7% (95% CI, 80.9–99.8)
CIN and AIS: 96.3% (95% CI, 79.5–99.8)
≥6 months persistent infection: 96.0% (95% CI, 94.4–97.2)

Per-protocol 9vHPV efficacy against HPV31, 33, 45, 52, and 58, 6 years post dose one:

Any high-grade diseases: 97.4% (95% CI, 85.0–99.9)
CIN and AIS: 98.2% (95% CI, 93.7–99.7)
12 months persistent infection: 96.7% (95% CI, 95.1–97.9)

Similar incidence of CIN, VIN, ValN, and persistent infection related to HPV6, 11, 16, and 18 between 4vHPV and 9vHPV

42, 43

Abbreviations: 4vHPV, quadrivalent HPV vaccine; 9vHPV, nonavalent HPV vaccine; AIS, adenocarcinoma in situ; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; ICC, invasive cervical carcinoma; RCT, randomized controlled trial; VaIN, vaginal intraepithelial neoplasia; VIN, vulvar intraepithelial neoplasia.