Trial Outcomes & Findings for Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls (NCT NCT04508309)
NCT ID: NCT04508309
Last Updated: 2025-01-30
Results Overview
Anti-HPV-16 IgG antibodies were measured using HPV-16 virus-like particle (VLP) enzyme-linked immunosorbent assay (ELISA) one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 international units (IU)/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1025 participants
Primary outcome timeframe
One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Results posted on
2025-01-30
Participant Flow
The study was conducted in one clinical site in Bangladesh and one clinical site in Ghana.
Participants were randomized approximately equally within site into one of five treatment groups.
Participant milestones
| Measure |
1. Cecolin at Month 0 and 6
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
205
|
206
|
204
|
205
|
205
|
|
Overall Study
Received First Vaccination
|
205
|
206
|
204
|
205
|
205
|
|
Overall Study
Received Second Vaccination
|
205
|
204
|
199
|
205
|
201
|
|
Overall Study
COMPLETED
|
205
|
206
|
203
|
204
|
203
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
1. Cecolin at Month 0 and 6
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls
Baseline characteristics by cohort
| Measure |
1. Cecolin at Month 0 and 6
n=205 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=206 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=204 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=205 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=205 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
Total
n=1025 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 1.46 • n=5 Participants
|
11.4 years
STANDARD_DEVIATION 1.37 • n=7 Participants
|
11.4 years
STANDARD_DEVIATION 1.47 • n=5 Participants
|
11.3 years
STANDARD_DEVIATION 1.39 • n=4 Participants
|
11.3 years
STANDARD_DEVIATION 1.49 • n=21 Participants
|
11.3 years
STANDARD_DEVIATION 1.44 • n=8 Participants
|
|
Sex: Female, Male
Female
|
205 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
205 Participants
n=4 Participants
|
205 Participants
n=21 Participants
|
1025 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
135 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
135 Participants
n=21 Participants
|
675 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
350 Participants
n=8 Participants
|
|
Region of Enrollment
Ghana
|
70 participants
n=5 Participants
|
70 participants
n=7 Participants
|
70 participants
n=5 Participants
|
70 participants
n=4 Participants
|
70 participants
n=21 Participants
|
350 participants
n=8 Participants
|
|
Region of Enrollment
Bangladesh
|
135 participants
n=5 Participants
|
136 participants
n=7 Participants
|
134 participants
n=5 Participants
|
135 participants
n=4 Participants
|
135 participants
n=21 Participants
|
675 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).Population: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-16 antibody negative at baseline, and had a valid serology result one month after second dose.
Anti-HPV-16 IgG antibodies were measured using HPV-16 virus-like particle (VLP) enzyme-linked immunosorbent assay (ELISA) one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 international units (IU)/mL.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=198 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=189 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=190 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=194 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=193 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose
|
1507.4 IU/mL
Interval 1329.0 to 1709.7
|
2408.7 IU/mL
Interval 2116.0 to 2741.8
|
3326.1 IU/mL
Interval 2960.6 to 3736.7
|
1352.4 IU/mL
Interval 1199.1 to 1525.3
|
2387.3 IU/mL
Interval 2091.4 to 2725.1
|
PRIMARY outcome
Timeframe: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).Population: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-18 antibody negative at baseline, and had a valid serology result one month after second dose.
Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.05 IU/mL.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=200 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=198 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=191 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=197 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=192 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Geometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose
|
382.7 IU/mL
Interval 337.8 to 433.6
|
534.7 IU/mL
Interval 469.4 to 609.1
|
535.2 IU/mL
Interval 474.9 to 603.3
|
306.1 IU/mL
Interval 269.3 to 347.9
|
379.0 IU/mL
Interval 327.7 to 438.3
|
SECONDARY outcome
Timeframe: Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 onlyPopulation: Per Protocol Population, PBNA Subset
Anti-HPV 16 serum neutralizing antibodies were measured in a subset of participants by pseudovirion-based neutralization assay (PBNA) at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 PBNA was a titer of \< 21. Samples were collected prior to the second dose and 1 month after the second dose for all treatment groups, and 18 months after the second dose for participants in Groups 1 and 4.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=40 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=41 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=41 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=40 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=40 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies
Prior to Second Dose
|
104.0 titer
Interval 78.6 to 137.7
|
95.1 titer
Interval 73.3 to 123.4
|
125.7 titer
Interval 95.3 to 165.6
|
71.6 titer
Interval 53.5 to 95.9
|
125.4 titer
Interval 85.2 to 184.5
|
|
Geometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies
One Month after Second Dose
|
16790.9 titer
Interval 11641.2 to 24218.6
|
32019.5 titer
Interval 25010.5 to 40992.7
|
48615.4 titer
Interval 36061.1 to 65540.5
|
14281.3 titer
Interval 10531.8 to 19365.7
|
31459.0 titer
Interval 24294.7 to 40736.0
|
|
Geometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies
18-Months after Second Dose
|
1541.9 titer
Interval 1076.9 to 2207.5
|
—
|
—
|
1368.1 titer
Interval 998.8 to 1874.0
|
—
|
SECONDARY outcome
Timeframe: Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 onlyPopulation: Per Protocol Population, PBNA Subset
Anti-HPV 18 serum neutralizing antibodies were measured in a subset of participants by pseudovirion-based neutralization assay (PBNA) at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 PBNA was a titer of \< 16. Samples were collected prior to the second dose and 1 month after the second dose for all treatment groups, and 18 months after the second dose for participants in Groups 1 and 4.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=40 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=41 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=40 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=41 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=41 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies
Prior to Second Dose
|
65.9 titer
Interval 42.1 to 103.2
|
51.1 titer
Interval 40.7 to 64.2
|
77.9 titer
Interval 58.1 to 104.5
|
47.6 titer
Interval 38.9 to 58.2
|
55.8 titer
Interval 36.3 to 85.6
|
|
Geometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies
One Month after Second Dose
|
6081.5 titer
Interval 3547.7 to 10425.1
|
9303.8 titer
Interval 7111.0 to 12172.7
|
11205.3 titer
Interval 8351.2 to 15034.8
|
6774.4 titer
Interval 5044.5 to 9097.6
|
7548.9 titer
Interval 5473.5 to 10411.2
|
|
Geometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies
18-Months after Second Dose
|
441.7 titer
Interval 301.8 to 646.5
|
—
|
—
|
423.4 titer
Interval 289.8 to 618.5
|
—
|
SECONDARY outcome
Timeframe: Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).Population: Per Protocol Population
Seroconversion rate is defined as the percentage of participants with a 4-fold rise in anti-HPV 16 IgG antibodies as measured by ELISA from baseline one month following the second dose.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=198 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=189 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=190 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=194 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=193 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Seroconversion Rate For HPV-16 One Month After the Second Dose
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).Population: Per Protocol Population
Seroconversion rate is defined as the percentage of participants with a 4-fold rise from baseline in anti HPV-18 IgG antibodies as measured by ELISA one month following the second dose.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=200 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=198 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=191 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=197 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=192 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Seroconversion Rate For HPV-18 One Month After the Second Dose
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).Population: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-16 antibody negative at baseline, and had a valid serology result one month after second dose.
Anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 IU/mL. Anti-HPV-16 IgG GMCs measured 1 month after the second dose were compared between the Gardasil at Month 0 and Cecolin at 24 months two-dose regimen (Group 5) and the Gardasil at Month 0 and 6 two-dose regimen (Group 4).
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=194 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=193 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
GMC of Anti-HPV-16 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen
|
1352.4 IU/mL
Interval 1199.1 to 1525.3
|
2387.3 IU/mL
Interval 2091.4 to 2725.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).Population: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-16 antibody negative at baseline, and had a valid serology result one month after second dose.
Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.405 IU/mL. Anti-HPV-18 IgG GMCs measured 1 month after the second dose were compared between the Gardasil at Month 0 and Cecolin at 24 Months two-dose regimen (Group 5) and the Gardasil at Month 0 and 6 two-dose regimen (Group 4).
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=197 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=192 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
GMC of Anti-HPV-18 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen
|
306.1 IU/mL
Interval 269.3 to 347.9
|
379.0 IU/mL
Interval 327.7 to 438.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 months after the second dose (Month 24)Population: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-16 antibody negative at baseline, and had a valid serology result 18-months after the second dose. Only participants who received the 6 month dose regimens were assessed for this endpoint.
Anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA 18 months after the second dose for participants who received a 6-month dosing regimen (Groups 1 and 4) only.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=198 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=195 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
GMC of Anti-HPV-16 IgG Antibodies 18-Months After Second Dose
|
138.5 IU/mL
Interval 120.8 to 158.7
|
119.1 IU/mL
Interval 104.1 to 136.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 months after the second dose (Month 24)Population: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-18 antibody negative at baseline, and had a valid serology result 18 months after the second dose. Only participants who received the 6-month dosing regimens were assessed for this endpoint.
Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA 18 months after the second dose for participants who received a 6-month dosing regimen (Groups 1 and 4) only.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=200 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=198 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
GMC of Anti-HPV-18 IgG Antibodies 18-Months After Second Dose
|
30.2 IU/mL
Interval 25.9 to 35.2
|
23.2 IU/mL
Interval 19.8 to 27.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For 30 minutes after each vaccination and for up to 7 days after each vaccinationPopulation: Total Vaccinated Population includes all randomized participants who received at least one dose of study vaccination.
Solicited adverse events (AEs) were assessed by study staff 30 minutes after each vaccination and then daily for seven days after each vaccination by the participants using a memory aid. The following specific solicited AEs were monitored for this trial: * Local Reactions: * Pain, erythema/redness, swelling, induration, pruritus, abscess. * General/Systemic Reactions: * Fever (oral or axillary temperature ≥ 38.0°C), headache, vomiting, nausea, fatigue, chills, muscle pain, cough, diarrhea, dizziness, allergic dermatitis, rash, syncope, and anorexia.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=205 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=206 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=204 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=205 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=205 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events
Within 30 Minutes of Vaccination: Any Local Reactions
|
4 Participants
|
15 Participants
|
2 Participants
|
12 Participants
|
5 Participants
|
|
Number of Participants With Solicited Adverse Events
Within 30 Minutes of Vaccination: Any Systemic Reactions
|
12 Participants
|
3 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants With Solicited Adverse Events
Within 7 Days of Vaccination: Any Local Reactions
|
131 Participants
|
113 Participants
|
106 Participants
|
138 Participants
|
120 Participants
|
|
Number of Participants With Solicited Adverse Events
Within 7 Days of Vaccination: Any Systemic Reactions
|
72 Participants
|
59 Participants
|
48 Participants
|
76 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: For 30 days after each dose (Month 0 (all groups), Month 6 (Groups 1 and 4), Month 12 (Group 2), and Month 24 (Groups 3 and 5)Population: Total Vaccinated Population includes all randomized participants who received at least one dose of study vaccination.
Unsolicited AEs were any AEs reported spontaneously by the participant, identified during interview at study visits, observed by the study personnel during study visits or those identified during review of medical records or source documents. Unsolicited AEs were events occurring from the time of each study injection through approximately 30 days after each vaccination. Solicited AEs with onset after the solicitation period and through Day 30 post-vaccination were captured as unsolicited AEs.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=205 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=206 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=204 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=205 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=205 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
43 Participants
|
41 Participants
|
46 Participants
|
52 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: From first dose through the end of study (up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5)Population: Total Vaccinated Population includes all randomized participants who received at least one dose of study vaccination.
An SAE was any AE that resulted in any of the following outcomes: 1. Death 2. Was life-threatening 3. Required inpatient hospitalization or prolongation of existing hospitalization. 4. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital abnormality or birth defect. 6. Important medical event that may not have resulted in one of the above outcomes but may have jeopardized the health of the study participant or (and) required medical or surgical intervention to prevent one of the outcomes listed in the above definition of SAEs. SAEs were collected from the time of first vaccination through the end of the study for each participant.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=205 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=206 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=204 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=205 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=205 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
4 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Prior to the second dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5).Population: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-16 antibody negative at baseline, and had a valid serology result prior to receiving the second dose.
To evaluate the persistence of antibody responses to HPV after a single dose of vaccine, anti-HPV-16 IgG antibodies were measured using HPV-16 VLP ELISA immediately prior to the second dose.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=198 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=191 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=193 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=196 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=197 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
GMC of Anti-HPV-16 IgG Antibodies Prior to the Second Dose
|
17.5 IU/mL
Interval 15.6 to 19.7
|
12.6 IU/mL
Interval 11.0 to 14.6
|
12.0 IU/mL
Interval 10.3 to 13.9
|
11.1 IU/mL
Interval 9.9 to 12.3
|
10.5 IU/mL
Interval 9.0 to 12.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Prior to the second dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5).Population: The Per Protocol Population includes participants who had no major protocol deviations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine, were HPV-18 antibody negative at baseline, and had a valid serology result prior to receiving the second dose.
To evaluate the persistence of antibody responses to HPV after a single dose of vaccine, anti-HPV-18 IgG antibodies were measured using HPV-16 VLP ELISA immediately prior to the second dose.
Outcome measures
| Measure |
1. Cecolin at Month 0 and 6
n=200 Participants
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=200 Participants
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=195 Participants
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=199 Participants
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=196 Participants
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
GMC of Anti-HPV-18 IgG Antibodies Prior to the Second Dose
|
6.5 IU/mL
Interval 5.9 to 7.3
|
4.3 IU/mL
Interval 3.8 to 4.9
|
4.4 IU/mL
Interval 3.8 to 5.1
|
4.1 IU/mL
Interval 3.6 to 4.6
|
3.2 IU/mL
Interval 2.7 to 3.8
|
Adverse Events
1. Cecolin at Month 0 and 6
Serious events: 4 serious events
Other events: 155 other events
Deaths: 0 deaths
2. Cecolin at Month 0 and 12
Serious events: 0 serious events
Other events: 145 other events
Deaths: 0 deaths
3. Cecolin at Month 0 and 24
Serious events: 5 serious events
Other events: 130 other events
Deaths: 0 deaths
4. Gardasil at Month 0 and 6
Serious events: 4 serious events
Other events: 165 other events
Deaths: 0 deaths
5. Gardasil at Month 0 and Cecolin at Month 24
Serious events: 3 serious events
Other events: 145 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
1. Cecolin at Month 0 and 6
n=205 participants at risk
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=206 participants at risk
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=204 participants at risk
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=205 participants at risk
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=205 participants at risk
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
General disorders
Pyrexia
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Abscess
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Typhoid fever
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
Other adverse events
| Measure |
1. Cecolin at Month 0 and 6
n=205 participants at risk
Participants received two doses of Cecolin 6 months apart (at Month 0 and Month 6).
|
2. Cecolin at Month 0 and 12
n=206 participants at risk
Participants received two doses of Cecolin 12 months apart (at Month 0 and Month 12).
|
3. Cecolin at Month 0 and 24
n=204 participants at risk
Participants received two doses of Cecolin 24 months apart (at Month 0 and Month 24).
|
4. Gardasil at Month 0 and 6
n=205 participants at risk
Participants received two doses of Gardasil 6 months apart (at Month 0 and Month 6)
|
5. Gardasil at Month 0 and Cecolin at Month 24
n=205 participants at risk
Participants received one dose of Gardasil at Month 0 and one dose of Cecolin at Month 24.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.9%
8/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.9%
6/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.4%
7/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.9%
6/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.4%
5/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
6/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.97%
2/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.5%
5/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
4.9%
10/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.98%
2/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
5/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.4%
5/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.0%
4/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.4%
7/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.98%
2/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
5/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
1.9%
4/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
1.5%
3/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.98%
2/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.98%
2/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.97%
2/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.5%
5/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.4%
7/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
General disorders
Vaccination site pain
|
64.9%
133/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
57.8%
119/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
52.0%
106/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
68.8%
141/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
59.0%
121/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
General disorders
Fatigue
|
2.4%
5/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.97%
2/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
4.9%
10/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.4%
5/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.9%
6/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
General disorders
Pyrexia
|
2.4%
5/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
1.5%
3/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.0%
4/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
4.4%
9/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.0%
4/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
General disorders
Chills
|
2.9%
6/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
1.5%
3/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.98%
2/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
4.4%
9/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.98%
2/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
10/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
4.9%
10/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
4.9%
10/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
4.9%
10/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
5.4%
11/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Malaria
|
4.4%
9/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.4%
7/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
5.4%
11/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
4.4%
9/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.9%
6/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
6/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.9%
8/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.5%
5/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.4%
5/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.49%
1/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.98%
2/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
0.00%
0/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.9%
6/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.0%
4/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.0%
4/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
11/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.9%
6/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.4%
7/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
10.7%
22/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
4.9%
10/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.98%
2/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.4%
5/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
1.5%
3/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
1.5%
3/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
1.5%
3/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Nervous system disorders
Headache
|
19.5%
40/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
17.5%
36/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
16.2%
33/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
24.4%
50/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
15.1%
31/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Nervous system disorders
Dizziness
|
5.4%
11/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.9%
8/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.9%
8/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.9%
8/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.9%
6/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
17/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
6.8%
14/206 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
2.5%
5/204 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
6.8%
14/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
3.4%
7/205 • Adverse events were collected through the end of study; up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER