Trial Outcomes & Findings for GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose (NCT NCT03943875)
NCT ID: NCT03943875
Last Updated: 2026-02-17
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
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
767 participants
Primary outcome timeframe
Month 7
Results posted on
2026-02-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
221
|
217
|
165
|
164
|
|
Overall Study
COMPLETED
|
168
|
173
|
140
|
130
|
|
Overall Study
NOT COMPLETED
|
53
|
44
|
25
|
34
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
6
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
12
|
13
|
6
|
9
|
|
Overall Study
Pregnancy
|
9
|
6
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
4
|
10
|
11
|
|
Overall Study
Moved
|
15
|
15
|
3
|
11
|
Baseline Characteristics
Per-Protocol Population
Baseline characteristics by cohort
| Measure |
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.
|
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
|
|---|---|---|---|---|---|
|
Age, Continuous
|
21.0 Years
STANDARD_DEVIATION 3.41 • n=221 Participants
|
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
|
|
Sex: Female, Male
Female
|
221 Participants
n=221 Participants
|
217 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
438 Participants
n=767 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=221 Participants
|
0 Participants
n=217 Participants
|
165 Participants
n=165 Participants
|
164 Participants
n=164 Participants
|
329 Participants
n=767 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
66 Participants
n=221 Participants
|
69 Participants
n=217 Participants
|
46 Participants
n=165 Participants
|
42 Participants
n=164 Participants
|
223 Participants
n=767 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=221 Participants
|
148 Participants
n=217 Participants
|
119 Participants
n=165 Participants
|
122 Participants
n=164 Participants
|
544 Participants
n=767 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=221 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=767 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=221 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=767 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=221 Participants
|
17 Participants
n=217 Participants
|
13 Participants
n=165 Participants
|
28 Participants
n=164 Participants
|
76 Participants
n=767 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=221 Participants
|
0 Participants
n=217 Participants
|
1 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
1 Participants
n=767 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=221 Participants
|
42 Participants
n=217 Participants
|
17 Participants
n=165 Participants
|
21 Participants
n=164 Participants
|
118 Participants
n=767 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=221 Participants
|
158 Participants
n=217 Participants
|
134 Participants
n=165 Participants
|
115 Participants
n=164 Participants
|
572 Participants
n=767 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=221 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=767 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=221 Participants
|
0 Participants
n=217 Participants
|
0 Participants
n=165 Participants
|
0 Participants
n=164 Participants
|
0 Participants
n=767 Participants
|
|
Seropositivity at Baseline
HPV-6
|
45 Participants
n=178 Participants • Per-Protocol Population
|
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
|
|
Seropositivity at Baseline
HPV-11
|
44 Participants
n=178 Participants • Per-Protocol Population
|
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
|
|
Seropositivity at Baseline
HPV-16
|
60 Participants
n=178 Participants • Per-Protocol Population
|
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
|
|
Seropositivity at Baseline
HPV-18
|
38 Participants
n=178 Participants • Per-Protocol Population
|
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
|
|
Seropositivity at Baseline
HPV-31
|
37 Participants
n=178 Participants • Per-Protocol Population
|
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
|
|
Seropositivity at Baseline
HPV-33
|
24 Participants
n=178 Participants • Per-Protocol Population
|
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
|
|
Seropositivity at Baseline
HPV-45
|
22 Participants
n=178 Participants • Per-Protocol Population
|
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
|
|
Seropositivity at Baseline
HPV-52
|
49 Participants
n=178 Participants • Per-Protocol Population
|
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
|
|
Seropositivity at Baseline
HPV-58
|
33 Participants
n=178 Participants • Per-Protocol Population
|
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
|
PRIMARY outcome
Timeframe: Month 7Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
Short-term Human Papillomavirus (HPV) Type-specific Antibody Response for Type HPV-6
|
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
|
100.00 % of participants with seroconversion
Interval 96.73 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-11
|
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
|
100.00 % of participants with seroconversion
Interval 96.73 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-16
|
99.15 % Seroconversion
Interval 95.37 to 99.98
|
100.00 % Seroconversion
Interval 97.0 to 100.0
|
100.00 % Seroconversion
Interval 96.76 to 100.0
|
100.00 % Seroconversion
Interval 96.48 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-18
|
99.29 % Seroconversion
Interval 96.08 to 99.98
|
100.00 % Seroconversion
Interval 97.26 to 100.0
|
100.00 % Seroconversion
Interval 97.02 to 100.0
|
100.00 % Seroconversion
Interval 96.84 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-31
|
99.29 % Seroconversion
Interval 96.11 to 99.98
|
100.00 % Seroconversion
Interval 97.34 to 100.0
|
100.00 % Seroconversion
Interval 97.09 to 100.0
|
100.00 % Seroconversion
Interval 96.97 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-33
|
99.35 % Seroconversion
Interval 96.44 to 99.98
|
100.00 % Seroconversion
Interval 97.6 to 100.0
|
100.00 % Seroconversion
Interval 97.2 to 100.0
|
100.00 % Seroconversion
Interval 97.09 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-45
|
99.36 % Seroconversion
Interval 96.48 to 99.98
|
100.00 % Seroconversion
Interval 97.62 to 100.0
|
100.00 % Seroconversion
Interval 97.14 to 100.0
|
100.00 % Seroconversion
Interval 97.09 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-52
|
99.22 % Seroconversion
Interval 95.76 to 99.98
|
100.00 % Seroconversion
Interval 97.2 to 100.0
|
100.00 % Seroconversion
Interval 96.76 to 100.0
|
100.00 % Seroconversion
Interval 96.61 to 100.0
|
PRIMARY outcome
Timeframe: Month 7Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
Short-term HPV Type-specific Antibody Response for Type HPV-58
|
99.31 % Seroconversion
Interval 96.22 to 99.98
|
100.00 % Seroconversion
Interval 97.4 to 100.0
|
100.00 % Seroconversion
Interval 97.11 to 100.0
|
100.00 % Seroconversion
Interval 97.0 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-6
|
100.00 % Seroconversion
Interval 97.11 to 100.0
|
100.00 % Seroconversion
Interval 97.14 to 100.0
|
100.00 % Seroconversion
Interval 96.95 to 100.0
|
99.06 % Seroconversion
Interval 94.86 to 99.98
|
PRIMARY outcome
Timeframe: Month 12Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-11
|
100.00 % Seroconversion
Interval 97.14 to 100.0
|
100.00 % Seroconversion
Interval 97.2 to 100.0
|
100.00 % Seroconversion
Interval 96.97 to 100.0
|
100.00 % Seroconversion
Interval 96.58 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-16
|
100.00 % Seroconversion
Interval 96.82 to 100.0
|
100.00 % Seroconversion
Interval 96.84 to 100.0
|
100.00 % Seroconversion
Interval 96.67 to 100.0
|
100.00 % Seroconversion
Interval 96.31 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-18
|
99.24 % Seroconversion
Interval 95.85 to 99.98
|
98.43 % Seroconversion
Interval 94.43 to 99.81
|
100.00 % Seroconversion
Interval 96.35 to 100.0
|
99.09 % Seroconversion
Interval 94.34 to 99.99
|
PRIMARY outcome
Timeframe: Month 12Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-31
|
100.00 % Seroconversion
Interval 97.26 to 100.0
|
100.00 % Seroconversion
Interval 97.2 to 100.0
|
100.00 % Seroconversion
Interval 97.0 to 100.0
|
99.13 % Seroconversion
Interval 95.25 to 99.98
|
PRIMARY outcome
Timeframe: Month 12Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-33
|
99.31 % Seroconversion
Interval 96.19 to 99.98
|
100.00 % Seroconversion
Interval 97.45 to 100.0
|
100.00 % Seroconversion
Interval 97.11 to 100.0
|
99.17 % Seroconversion
Interval 95.44 to 99.98
|
PRIMARY outcome
Timeframe: Month 12Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-45
|
98.66 % Seroconversion
Interval 95.24 to 99.84
|
97.92 % Seroconversion
Interval 94.03 to 99.57
|
99.18 % Seroconversion
Interval 95.52 to 99.98
|
95.00 % Seroconversion
Interval 89.43 to 98.14
|
PRIMARY outcome
Timeframe: Month 12Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-52
|
100.00 % Seroconversion
Interval 97.02 to 100.0
|
100.00 % Seroconversion
Interval 97.07 to 100.0
|
100.00 % Seroconversion
Interval 96.64 to 100.0
|
100.00 % Seroconversion
Interval 96.48 to 100.0
|
PRIMARY outcome
Timeframe: Month 12Yes/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 |
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.
|
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.
|
|---|---|---|---|---|
|
HPV Type-specific Antibody Response for Type HPV-58
|
99.27 % Seroconversion
Interval 96.0 to 99.98
|
100.00 % Seroconversion
Interval 97.22 to 100.0
|
100.00 % Seroconversion
Interval 97.02 to 100.0
|
99.14 % Seroconversion
Interval 95.29 to 99.98
|
Adverse Events
Females, 3 Dose Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Females, 2 Dose With Delayed 3rd Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Males, 3 Dose Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Males, 2 Dose With Delayed 3rd Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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