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Table 1 Characteristics of randomised control trials included in the review

From: HPV catch-up vaccination of young women: a systematic review and meta-analysis

Trial [reference] FUTURE (protocol 5)[2023] FUTURE (protocol 7)[23][24][26][39] FUTURE I (protocol 13)[23][2528] FUTURE II (protocol 15)[23][2527] FUTURE II (protocol 19)[29][30] PATRICIA[3133][33][40] Harper[3438]
Phase IIa II III III   III III
Age range 16-25 years 16-23 years 16-24 years 15-26 years 24-45 years 15-25 years 15-25 years
Countries included USA 5 countries 16 countries 13 countries 38 international study sites 14 countries North America and Brazil
Period of enrollment October 1998 to November 1999 2002-2007 January 2002 – March 2003 June 2002 - May 2003 June 2004 - April 2005 May 2004 -June 2005 November 2003 – July 2004
Inclusion criteria Not pregnant, no prior Pap tests and with a lifetime history of 0-5 male sex partners Non pregnant, healthy women, no prior abnormal Pap smears, and with a lifetime history of 0-4 male sex partners. Among virgins, enrolment was limited to those 18 years and over of age and seeking contraception. Not pregnant, reporting no prior Pap tests and lifetime history of 0-4 sex partners. No history of genital warts Not pregnant, reporting no prior Pap tests and lifetime history of 0-4 sex partners. Healthy non pregnant women, agreed to contraception, intact cervix, with no history of coloscopy. Healthy non pregnant women, 0-6 sexual partners, agreed to contraception, intact cervix, with no history of coloscopy. Not breastfeeding and without chronic or autoimmune disease Healthy women with 0-6 sexual partners. No history of abnormal Pap test or ablative or extensional treatment for external condylomata; who were 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.
Intervention comparator
Vaccine HPV 16 vaccine (N = 768) HPV-6/11/16/18 (N = 276) HPV-6/11/16/18 (N = 2723) HPV-6/11/16/18 (N = 6087) HPV 6, 11, 16, 18 (N = 1911) HPV16/18 (N = 8093) HPV 16/18 (N = 560)
Comparator Placebo (N = 765) Placebo (N = 275) Placebo (N = 2732) Placebo (N = 6080) Placebo (N = 1908) Hepatitt A vaccine (N = 8069) Placebo (N = 553)
Administration schedule day 1, month 2 and month 6. day 1, month 2 and month 6. day 1, month 2 and month 6. day 1, month 2 and month 6. day 1, month 2 and month 6. 0,1 and 6 month 0,1 and 6 month
Length of follow up Up to 48 months 36 months and extension study of 2 years Up to 48 months Up to 48 months Median 4 years Up to 48 months incl 27 mths and 4,5 yrs; ≤ 8.4 yrs (Brazilian centers)
Study populations
Intention to treat (ITT) Subjects who received at least one vaccination, included all protocol violators and subjects who tested positive for HPV-16 infection at enrollment. Subjects who were naıve to the relevant HPV type(s) at enrolment and had received at least one vaccination Subjects who received at least 1 dose of vaccine or placebo and returned for follow-up. Subjects who received at least 1 dose of vaccine or placebo and returned for follow-up. Subjects who received X1 dose of vaccine or placebo and returned for follow-up. Total vacine cohort (TVC) included all who received at least one vaccine dose and were evaluable for efficacy, irrespctive of baseline HPV status, cytological status, and serostatus. Subjects who had received at least one dose of study vaccine or placebo in the initial efficacy study, and who had any data available for outcome measurement in the extended follow-up phase.
Per protocol population (PPP) Subjects who tested seronegative for HPV16 at the first study visit, tested negative for HPV16 DNA at all visits between day 1 and month 7 inclusive, and completed the entire three dose vaccine series. Subjects who were PCR and seronegative to HPV 6, 11, 16, or 18 at enrolment, remained PCR-negative to the same vaccine-HPVtype (s) (to which they were naı¨ve at enrolment) through 1 month postdose three, received three doses of vaccine or placebo within 1 year, and did not violate the protocol. Subjects who received all 3 doses of vaccine or placebo within 12 months. Were seronegative and HPV DNA negative on PCR analysis for HPV-6, HPV-11, HPV-16, or HPV-18. Subjects who received all 3 doses of vaccine or placebo within 12 months. Were seronegative and HPV DNA negative on PCR analysis for HPV-6, HPV-11, HPV-16, or HPV-18. Subjects who were seronegative at day 1 and PCR-negative (from day 1 through month 7 to the relevant vaccine HPV type(s) and did not violate the protocol. According to protocol for efficacy (ATP-E) included all participants that received three doses of vaccine or placebo with a negative HPV DNA test, seronegative for HPV16 and/or 18 and with normal or low-grade cytology on day 1. Subjects in the extended follow up phase who received three doses of HPV 16/18 vaccine or placebo, and who were negative for high-risk HPV DNA and seronegative for HPV 16 and 18 DNA
Safety population Included all randomized participants   Included all randomized participants with follow-up information Included all subjects who completed the vaccination report card from day 1 through day 15 after Included all randomized participants with follow-up information Included all randomized participants Included all assessible women who did not use any investigational or non-registered product or any HPV vaccine other than study vaccine during the study period.
Outcomes used in article HPV related CIN2+ HPV related CIN2+ VIN2+ /VaIN2+ HPV related Condyloma SAE CIN2+ HPV related CIN2+ VIN2+ /VaIN2+ related and not Condyloma SAE CIN2+ HPV related CIN2+ VIN2+ /VaIN2+ related and not Condyloma SAE CIN2 Condyloma VIN2+ VaIN2+ SAE CIN2+ HPV related CIN2+ SAE mortality CIN2+ SAE
Risk of bias None None None None None None None
Funding source Merck Research Laboratories Merck Research Laboratories Merck Research Laboratories Merck Research Laboratories Merck Research Laboratories GlaxoSmith Kline Biologicals GlaxoSmith Kline Biologicals