Trial Outcomes & Findings for Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil (NCT NCT00524745)
NCT ID: NCT00524745
Last Updated: 2017-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
903 participants
Primary outcome timeframe
25 months
Results posted on
2017-04-14
Participant Flow
21 schools were (1) matched according to size, urban/rural location and ethnicity; (2) assigned to one of four groups; and (3) randomized to one of four schedules All girls 11-13 years of age in these schools were eligible to participate.
Participant milestones
| Measure |
0,3,9 Month Schedule
|
0,6,12 Month Schedule
|
0,12,24 Month Schedule
|
Standard (0,2,6 Month) Schedule
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
229
|
206
|
241
|
227
|
|
Overall Study
COMPLETED
|
195
|
193
|
212
|
205
|
|
Overall Study
NOT COMPLETED
|
34
|
13
|
29
|
22
|
Reasons for withdrawal
| Measure |
0,3,9 Month Schedule
|
0,6,12 Month Schedule
|
0,12,24 Month Schedule
|
Standard (0,2,6 Month) Schedule
|
|---|---|---|---|---|
|
Overall Study
subject withdrawal or lost to follow up
|
34
|
13
|
29
|
22
|
Baseline Characteristics
Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil
Baseline characteristics by cohort
| Measure |
0,3,9 Month Schedule
n=229 Participants
|
0,6,12 Month Schedule
n=206 Participants
|
0,12,24 Month Schedule
n=241 Participants
|
Standard (0,2,6 Month) Schedule
n=227 Participants
|
Total
n=903 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
229 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
903 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
903 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Vietnam
|
229 participants
n=5 Participants
|
206 participants
n=7 Participants
|
241 participants
n=5 Participants
|
227 participants
n=4 Participants
|
903 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 25 monthsOutcome measures
| Measure |
0,3,9 Month Schedule
n=194 Participants
|
0,6,12 Month Schedule
n=193 Participants
|
0,12,24 Month Schedule
n=212 Participants
|
Standard (0,2,6 Month) Schedule
n=205 Participants
|
|---|---|---|---|---|
|
Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
|
0.93 GMT ratio
Interval 0.71 to 1.21
|
0.99 GMT ratio
Interval 0.75 to 1.3
|
0.63 GMT ratio
Interval 0.48 to 0.83
|
1.0 GMT ratio
Standard schedule is the comparator for the GMT ratio outcome reported.
|
PRIMARY outcome
Timeframe: 25 monthsOutcome measures
| Measure |
0,3,9 Month Schedule
n=195 Participants
|
0,6,12 Month Schedule
n=193 Participants
|
0,12,24 Month Schedule
n=213 Participants
|
Standard (0,2,6 Month) Schedule
n=205 Participants
|
|---|---|---|---|---|
|
Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
|
0.88 GMT ratio
Interval 0.69 to 1.12
|
0.92 GMT ratio
Interval 0.71 to 1.18
|
0.77 GMT ratio
Interval 0.62 to 0.96
|
1.0 GMT ratio
Standard schedule is the comparator for the GMT ratio outcome reported.
|
SECONDARY outcome
Timeframe: 25 monthsOutcome measures
| Measure |
0,3,9 Month Schedule
n=191 Participants
|
0,6,12 Month Schedule
n=191 Participants
|
0,12,24 Month Schedule
n=207 Participants
|
Standard (0,2,6 Month) Schedule
n=203 Participants
|
|---|---|---|---|---|
|
Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
|
1.07 GMT ratio
Interval 0.8 to 1.44
|
1.14 GMT ratio
Interval 0.85 to 1.52
|
0.64 GMT ratio
Interval 0.46 to 0.9
|
1.0 GMT ratio
Standard schedule is the comparator for the GMT ratio outcome reported.
|
SECONDARY outcome
Timeframe: 25 monthsOutcome measures
| Measure |
0,3,9 Month Schedule
n=195 Participants
|
0,6,12 Month Schedule
n=193 Participants
|
0,12,24 Month Schedule
n=212 Participants
|
Standard (0,2,6 Month) Schedule
n=205 Participants
|
|---|---|---|---|---|
|
Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
|
0.86 GMT ratio
Interval 0.7 to 1.06
|
0.86 GMT ratio
Interval 0.69 to 1.06
|
0.96 GMT ratio
Interval 0.8 to 1.15
|
1.0 GMT ratio
Standard schedule is the comparator for the GMT ratio outcome reported.
|
Adverse Events
0,3,9 Month Schedule
Serious events: 0 serious events
Other events: 157 other events
Deaths: 0 deaths
0,6,12 Month Schedule
Serious events: 0 serious events
Other events: 133 other events
Deaths: 0 deaths
0,12,24 Month Schedule
Serious events: 0 serious events
Other events: 148 other events
Deaths: 0 deaths
Standard (0,2,6 Month) Schedule
Serious events: 0 serious events
Other events: 131 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0,3,9 Month Schedule
n=229 participants at risk
|
0,6,12 Month Schedule
n=206 participants at risk
|
0,12,24 Month Schedule
n=240 participants at risk；n=241 participants at risk
|
Standard (0,2,6 Month) Schedule
n=227 participants at risk
|
|---|---|---|---|---|
|
General disorders
Fever post dose 1
|
2.6%
6/229 • Solicited local reactions within 7 days post-vacciantion
|
1.9%
4/206 • Solicited local reactions within 7 days post-vacciantion
|
2.9%
7/240 • Solicited local reactions within 7 days post-vacciantion
|
2.2%
5/227 • Solicited local reactions within 7 days post-vacciantion
|
|
General disorders
Fever post dose 2
|
2.2%
5/229 • Solicited local reactions within 7 days post-vacciantion
|
0.97%
2/206 • Solicited local reactions within 7 days post-vacciantion
|
1.7%
4/240 • Solicited local reactions within 7 days post-vacciantion
|
2.6%
6/227 • Solicited local reactions within 7 days post-vacciantion
|
|
General disorders
Fever post-dose 3
|
3.9%
9/229 • Solicited local reactions within 7 days post-vacciantion
|
2.9%
6/206 • Solicited local reactions within 7 days post-vacciantion
|
5.0%
12/240 • Solicited local reactions within 7 days post-vacciantion
|
5.3%
12/227 • Solicited local reactions within 7 days post-vacciantion
|
|
General disorders
Pain at injection site post dose 1
|
58.1%
133/229 • Solicited local reactions within 7 days post-vacciantion
|
46.6%
96/206 • Solicited local reactions within 7 days post-vacciantion
|
47.5%
114/240 • Solicited local reactions within 7 days post-vacciantion
|
52.9%
120/227 • Solicited local reactions within 7 days post-vacciantion
|
|
General disorders
Pain at injection site post dose 2
|
54.1%
124/229 • Solicited local reactions within 7 days post-vacciantion
|
60.2%
124/206 • Solicited local reactions within 7 days post-vacciantion
|
55.8%
134/240 • Solicited local reactions within 7 days post-vacciantion
|
51.5%
117/227 • Solicited local reactions within 7 days post-vacciantion
|
|
General disorders
Pain at injection site post dose 3
|
65.1%
149/229 • Solicited local reactions within 7 days post-vacciantion
|
62.1%
128/206 • Solicited local reactions within 7 days post-vacciantion
|
57.9%
139/240 • Solicited local reactions within 7 days post-vacciantion
|
53.3%
121/227 • Solicited local reactions within 7 days post-vacciantion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place