. Author manuscript; available in PMC: 2009 Aug 19.

Published in final edited form as: Vaccine. 2008 Aug 19;26(Suppl 10):K53–K61. doi: 10.1016/j.vaccine.2008.06.002

Table 3.

Inclusion criteria for according to protocol (ATP) and modified intention to treat (MITT) or intention to treat (ITT) analyses.

Study	ATP	MITT/ITT
GSK 001/007^a	Seronegative for HPV-16 and 18; negative for high-risk HPV DNA at enrollment. HPV-16/18 DNA negative at month 6. Received all 3 doses. No protocol violations. Start case counting at dose 3 (month 6).	MITT: Seronegative for HPV-16 and 18; negative for high-risk HPV DNA at enrollment‥ Received at least 1 dose. Start case counting at 1^st dose.
Merck 007	-6/11/16/18 DNA- and seronegative at enrollment. Remained DNA-negative to same vaccine HPV type(s) (to which they were negative at enrollment) through 1 month post dose 3. Received all 3 doses within 1 year. No protocol violations. Start case counting 1 month post dose 3.	MITT: -6/11/16/18 DNA- and seronegative at enrollment. Received at least 1 dose. Start case counting at month 1.
PATRICIA	Not reported in interim analysis.	MITT: -16/18 DNA- and sero-negative at enrollment. Received at least 1 dose. Start case counting at 1^st dose.
FUTURE I/II	-6/11/16/18 DNA- and seronegative at enrollment. Remained DNA-negative to the same vaccine HPV type(s) (to which they were negative at enrollment) through 1 month post dose 3. Received all 3 doses within one year. No protocol violations. Start case counting 1 month post dose 3.	MITT: -6/11/16/18 DNA- and seronegative at enrollment. Received at least 1 dose. Start case counting at month 1. ITT: All randomized participants regardless of HPV DNA or cervical disease status at entry. Start case counting at 1^st dose.

For the analyses reported in [8].

ATP: According to protocol; FUTURE: Females united to unilaterally reduce endo/ectocervical disease; GSK: GlaxoSmithKline; ITT: Intention to treat; MITT: Modified intention to treat; PATRICIA: Papilloma trial against cancer in young adults.