Trial Outcomes & Findings for GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose (NCT NCT03943875)
NCT ID: NCT03943875
Last Updated: 2026-04-16
Results Overview
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as % of participants who seroconvert
COMPLETED
PHASE4
767 participants
Month 7
2026-04-16
Participant Flow
Participant milestones
| Measure |
Males, 2 Dose With Delayed 3rd Dose
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Overall Study
COMPLETED
|
130
|
168
|
173
|
140
|
|
Overall Study
NOT COMPLETED
|
34
|
53
|
44
|
25
|
|
Overall Study
STARTED
|
164
|
221
|
217
|
165
|
Reasons for withdrawal
| Measure |
Males, 2 Dose With Delayed 3rd Dose
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
14
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
9
|
12
|
13
|
6
|
|
Overall Study
Pregnancy
|
0
|
9
|
6
|
0
|
|
Overall Study
Protocol Violation
|
11
|
3
|
4
|
10
|
|
Overall Study
Moved
|
11
|
15
|
15
|
3
|
Baseline Characteristics
Per-Protocol Population
Baseline characteristics by cohort
| Measure |
Females, 2 Dose With Delayed 3rd Dose
n=217 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=165 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Males, 2 Dose With Delayed 3rd Dose
n=164 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Total
n=767 Participants
Total of all reporting groups
|
Females, 3 Dose Standard
n=221 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
21.3 Years
STANDARD_DEVIATION 3.53 • n=217 Participants
|
20.82 Years
STANDARD_DEVIATION 3.78 • n=165 Participants
|
20.63 Years
STANDARD_DEVIATION 3.85 • n=164 Participants
|
20.96 Years
STANDARD_DEVIATION 3.62 • n=767 Participants
|
21.0 Years
STANDARD_DEVIATION 3.41 • n=221 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
438 Participants
n=767 Participants
|
221 Participants
n=221 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=217 Participants
|
165 Participants
n=165 Participants
|
164 Participants
n=164 Participants
|
329 Participants
n=767 Participants
|
0 Participants
n=221 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
69 Participants
n=217 Participants
|
46 Participants
n=165 Participants
|
42 Participants
n=164 Participants
|
223 Participants
n=767 Participants
|
66 Participants
n=221 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
148 Participants
n=217 Participants
|
119 Participants
n=165 Participants
|
122 Participants
n=164 Participants
|
544 Participants
n=767 Participants
|
155 Participants
n=221 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=767 Participants
|
0 Participants
n=221 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=767 Participants
|
0 Participants
n=221 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=217 Participants
|
13 Participants
n=165 Participants
|
28 Participants
n=164 Participants
|
76 Participants
n=767 Participants
|
18 Participants
n=221 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=217 Participants
|
1 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
1 Participants
n=767 Participants
|
0 Participants
n=221 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=217 Participants
|
17 Participants
n=165 Participants
|
21 Participants
n=164 Participants
|
118 Participants
n=767 Participants
|
38 Participants
n=221 Participants
|
|
Race (NIH/OMB)
White
|
158 Participants
n=217 Participants
|
134 Participants
n=165 Participants
|
115 Participants
n=164 Participants
|
572 Participants
n=767 Participants
|
165 Participants
n=221 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=767 Participants
|
0 Participants
n=221 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=767 Participants
|
0 Participants
n=221 Participants
|
|
Seropositivity at Baseline
HPV-6
|
50 Participants
n=183 Participants • Per-Protocol Population
|
22 Participants
n=145 Participants • Per-Protocol Population
|
26 Participants
n=137 Participants • Per-Protocol Population
|
143 Participants
n=643 Participants • Per-Protocol Population
|
45 Participants
n=178 Participants • Per-Protocol Population
|
|
Seropositivity at Baseline
HPV-11
|
47 Participants
n=183 Participants • Per-Protocol Population
|
21 Participants
n=145 Participants • Per-Protocol Population
|
26 Participants
n=137 Participants • Per-Protocol Population
|
138 Participants
n=643 Participants • Per-Protocol Population
|
44 Participants
n=178 Participants • Per-Protocol Population
|
|
Seropositivity at Baseline
HPV-16
|
62 Participants
n=183 Participants • Per-Protocol Population
|
33 Participants
n=145 Participants • Per-Protocol Population
|
34 Participants
n=137 Participants • Per-Protocol Population
|
189 Participants
n=643 Participants • Per-Protocol Population
|
60 Participants
n=178 Participants • Per-Protocol Population
|
|
Seropositivity at Baseline
HPV-18
|
50 Participants
n=183 Participants • Per-Protocol Population
|
23 Participants
n=145 Participants • Per-Protocol Population
|
22 Participants
n=137 Participants • Per-Protocol Population
|
133 Participants
n=643 Participants • Per-Protocol Population
|
38 Participants
n=178 Participants • Per-Protocol Population
|
|
Seropositivity at Baseline
HPV-31
|
46 Participants
n=183 Participants • Per-Protocol Population
|
20 Participants
n=145 Participants • Per-Protocol Population
|
17 Participants
n=137 Participants • Per-Protocol Population
|
120 Participants
n=643 Participants • Per-Protocol Population
|
37 Participants
n=178 Participants • Per-Protocol Population
|
|
Seropositivity at Baseline
HPV-33
|
31 Participants
n=183 Participants • Per-Protocol Population
|
15 Participants
n=145 Participants • Per-Protocol Population
|
12 Participants
n=137 Participants • Per-Protocol Population
|
82 Participants
n=643 Participants • Per-Protocol Population
|
24 Participants
n=178 Participants • Per-Protocol Population
|
|
Seropositivity at Baseline
HPV-45
|
30 Participants
n=183 Participants • Per-Protocol Population
|
18 Participants
n=145 Participants • Per-Protocol Population
|
12 Participants
n=137 Participants • Per-Protocol Population
|
82 Participants
n=643 Participants • Per-Protocol Population
|
22 Participants
n=178 Participants • Per-Protocol Population
|
|
Seropositivity at Baseline
HPV-52
|
53 Participants
n=183 Participants • Per-Protocol Population
|
33 Participants
n=145 Participants • Per-Protocol Population
|
30 Participants
n=137 Participants • Per-Protocol Population
|
165 Participants
n=643 Participants • Per-Protocol Population
|
49 Participants
n=178 Participants • Per-Protocol Population
|
|
Seropositivity at Baseline
HPV-58
|
43 Participants
n=183 Participants • Per-Protocol Population
|
19 Participants
n=145 Participants • Per-Protocol Population
|
16 Participants
n=137 Participants • Per-Protocol Population
|
111 Participants
n=643 Participants • Per-Protocol Population
|
33 Participants
n=178 Participants • Per-Protocol Population
|
PRIMARY outcome
Timeframe: Month 7Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=111 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=133 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=133 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=123 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Short-term Human Papillomavirus (HPV) Type-specific Antibody Response for Type HPV-6
|
100.00 % of participants with seroconversion
Interval 96.73 to 100.0
|
99.25 % of participants with seroconversion
Interval 95.88 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.26 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.05 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 11, measured as measured as % of participants who seroconvert.
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=111 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=134 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=136 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=124 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-11
|
100.00 % of participants with seroconversion
Interval 96.73 to 100.0
|
99.25 % of participants with seroconversion
Interval 95.91 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.32 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.07 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 16, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=103 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=118 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=121 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=112 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-16
|
100.00 % of participants with seroconversion
Interval 96.48 to 100.0
|
99.15 % of participants with seroconversion
Interval 95.37 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.0 to 100.0
|
100.00 % of participants with seroconversion
Interval 96.76 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 18, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=115 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=140 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=133 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=122 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-18
|
100.00 % of participants with seroconversion
Interval 96.84 to 100.0
|
99.29 % of participants with seroconversion
Interval 96.08 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.26 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.02 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 31, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=120 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=141 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=137 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=125 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-31
|
100.00 % of participants with seroconversion
Interval 96.97 to 100.0
|
99.29 % of participants with seroconversion
Interval 96.11 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.34 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.09 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 33, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=125 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=154 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=152 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=130 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-33
|
100.00 % of participants with seroconversion
Interval 97.09 to 100.0
|
99.35 % of participants with seroconversion
Interval 96.44 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.6 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.2 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 45, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=125 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=156 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=153 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=127 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-45
|
100.00 % of participants with seroconversion
Interval 97.09 to 100.0
|
99.36 % of participants with seroconversion
Interval 96.48 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.62 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.14 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 52, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=107 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=129 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=130 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=112 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-52
|
100.00 % of participants with seroconversion
Interval 96.61 to 100.0
|
99.22 % of participants with seroconversion
Interval 95.76 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.2 to 100.0
|
100.00 % of participants with seroconversion
Interval 96.76 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 58, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=121 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=145 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=140 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=126 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-58
|
100.00 % of participants with seroconversion
Interval 97.0 to 100.0
|
99.31 % of participants with seroconversion
Interval 96.22 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.4 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.11 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=106 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=126 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=127 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=119 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-6
|
99.06 % of participants with seroconversion
Interval 94.86 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.11 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.14 to 100.0
|
100.00 % of participants with seroconversion
Interval 96.95 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 11, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=106 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=127 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=130 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=120 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-11
|
100.00 % of participants with seroconversion
Interval 96.58 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.14 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.2 to 100.0
|
100.00 % of participants with seroconversion
Interval 96.97 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 16, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=98 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=114 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=115 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=109 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-16
|
100.00 % of participants with seroconversion
Interval 96.31 to 100.0
|
100.00 % of participants with seroconversion
Interval 96.82 to 100.0
|
100.00 % of participants with seroconversion
Interval 96.84 to 100.0
|
100.00 % of participants with seroconversion
Interval 96.67 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 18, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=110 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=132 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=127 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=118 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-18
|
99.09 % of participants with seroconversion
Interval 94.34 to 99.99
|
99.24 % of participants with seroconversion
Interval 95.85 to 99.98
|
98.43 % of participants with seroconversion
Interval 94.43 to 99.81
|
100.00 % of participants with seroconversion
Interval 96.35 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 31, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=115 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=133 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=130 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=121 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-31
|
99.13 % of participants with seroconversion
Interval 95.25 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.26 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.2 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.0 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 33, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=120 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=144 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=143 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=126 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-33
|
99.17 % of participants with seroconversion
Interval 95.44 to 99.98
|
99.31 % of participants with seroconversion
Interval 96.19 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.45 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.11 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 45, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=120 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=149 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=144 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=122 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-45
|
95.00 % of participants with seroconversion
Interval 89.43 to 98.14
|
98.66 % of participants with seroconversion
Interval 95.24 to 99.84
|
97.92 % of participants with seroconversion
Interval 94.03 to 99.57
|
99.18 % of participants with seroconversion
Interval 95.52 to 99.98
|
PRIMARY outcome
Timeframe: Month 12Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 52, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=103 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=122 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=124 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=108 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-52
|
100.00 % of participants with seroconversion
Interval 96.48 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.02 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.07 to 100.0
|
100.00 % of participants with seroconversion
Interval 96.64 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Population: The per-protocol population only includes participants meeting the following criteria: the participant received all vaccine injections within the predetermined time ranges, adequate serum samples were collected at the appropriate time intervals, and the participant was seronegative at baseline for the HPV type being analyzed. Therefore, the number of participants analyzed will vary for each HPV type being analyzed.
Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 58, measured as % of participants who seroconvert
Outcome measures
| Measure |
Males, 2 Dose With Delayed 3rd Dose
n=116 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Females, 3 Dose Standard
n=137 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
Females, 2 Dose With Delayed 3rd Dose
n=131 Participants
Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.
9-valent HPV vaccine, 2 dose efficacy: Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.
|
Males, 3 Dose Standard
n=122 Participants
Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.
9-valent HPV vaccine, 3 doses standard timing: Will be comparison group for 2 dose efficacy group.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-58
|
99.14 % of participants with seroconversion
Interval 95.29 to 99.98
|
99.27 % of participants with seroconversion
Interval 96.0 to 99.98
|
100.00 % of participants with seroconversion
Interval 97.22 to 100.0
|
100.00 % of participants with seroconversion
Interval 97.02 to 100.0
|
Adverse Events
Females, 2 Dose With Delayed 3rd Dose
Males, 3 Dose Standard
Males, 2 Dose With Delayed 3rd Dose
Females, 3 Dose Standard
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place