Trial Outcomes & Findings for Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) (NCT NCT00851643)
NCT ID: NCT00851643
Last Updated: 2016-02-03
Results Overview
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
158 participants
Primary outcome timeframe
4 weeks postdose 3 (Phase A)
Results posted on
2016-02-03
Participant Flow
158 participants were enrolled. Of the enrolled 158 participants, 8 were screening failures. 150 participants were randomized to the base study (up to 12 months), conducted in 2 phases, Phase A and Phase B. Some participants continued in a voluntary, long-term extension of the study (up to 36 months).
In Phase A, participants were randomized to quadrivalent Human Papillomavirus (qHPV), Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS), or Octavalent HPV with 30 mcg IMX/AAHS. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.
Participant milestones
| Measure |
qHPV (GARDASIL™) - Phase A Control
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 15 mcg IMX / AAHS
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 30 mcg IMX / AAHS
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
qHPV (GARDASIL™) - Phase B Control
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 60 mcg IMX / AAHS
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 120 mcg IMX / AAHS
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
|---|---|---|---|---|---|---|
|
Base Study (Up to 12 Months)
STARTED
|
15
|
30
|
30
|
15
|
30
|
30
|
|
Base Study (Up to 12 Months)
COMPLETED
|
14
|
30
|
30
|
15
|
30
|
29
|
|
Base Study (Up to 12 Months)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Extension Study (Up to 36 Months)
STARTED
|
10
|
19
|
19
|
7
|
21
|
15
|
|
Extension Study (Up to 36 Months)
COMPLETED
|
6
|
15
|
14
|
5
|
19
|
14
|
|
Extension Study (Up to 36 Months)
NOT COMPLETED
|
4
|
4
|
5
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
qHPV (GARDASIL™) - Phase A Control
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 15 mcg IMX / AAHS
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 30 mcg IMX / AAHS
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
qHPV (GARDASIL™) - Phase B Control
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 60 mcg IMX / AAHS
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 120 mcg IMX / AAHS
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
|---|---|---|---|---|---|---|
|
Base Study (Up to 12 Months)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Base Study (Up to 12 Months)
Other
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Extension Study (Up to 36 Months)
Lost to Follow-up
|
4
|
2
|
4
|
1
|
2
|
0
|
|
Extension Study (Up to 36 Months)
Moved
|
0
|
2
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
Baseline characteristics by cohort
| Measure |
qHPV (GARDASIL™) - Phase A Control
n=15 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 15 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 30 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
qHPV (GARDASIL™) - Phase B Control
n=15 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 60 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Octavalent HPV With 120 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
20.3 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
20.8 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
20.2 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
19.9 years
STANDARD_DEVIATION 1.6 • n=4 Participants
|
20.5 years
STANDARD_DEVIATION 1.8 • n=21 Participants
|
20.8 years
STANDARD_DEVIATION 2.0 • n=10 Participants
|
20.5 years
STANDARD_DEVIATION 1.7 • n=115 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
150 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
Australia
|
15 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
15 participants
n=4 Participants
|
30 participants
n=21 Participants
|
30 participants
n=10 Participants
|
150 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 4 weeks postdose 3 (Phase A)Population: Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Outcome measures
| Measure |
qHPV (GARDASIL™) - Phase A Control
n=15 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
|
Octavalent HPV With 15 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
|
Octavalent HPV With 30 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Anti-HPV 16 (N=11, N=23, N=24)
|
2381.9 mMU/mL
Interval 1558.5 to 3640.4
|
3961.8 mMU/mL
Interval 2982.6 to 5262.4
|
7484.4 mMU/mL
Interval 5493.9 to 10196.1
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Anti-HPV 18 (N=11, N=24, N=24)
|
568.7 mMU/mL
Interval 284.8 to 1135.7
|
1375.7 mMU/mL
Interval 966.4 to 1958.2
|
2315.3 mMU/mL
Interval 1453.4 to 3688.3
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Anti-HPV 45 (N=11, N=26, N=25)
|
10.8 mMU/mL
Interval to 52.7
The lower bound of the 95% confidence interval is below the level of detectability (\<4).
|
1042.8 mMU/mL
Interval 760.8 to 1429.1
|
2116.5 mMU/mL
Interval 1329.7 to 3368.8
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Anti-HPV 52 (N=9, N=23, N=25)
|
NA mMU/mL
The lower and upper bounds of the 95% confidence interval are below the level of detectability (\<16 to \<16).
|
2531.1 mMU/mL
Interval 1798.6 to 3561.9
|
4292.0 mMU/mL
Interval 2997.7 to 6145.2
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Anti-HPV 58 (N=10, N=24, N=22)
|
17.7 mMU/mL
Interval to 86.1
The lower bound of the 95% confidence interval is below the level of detectability (\<6).
|
1759.2 mMU/mL
Interval 1276.5 to 2424.4
|
3146.4 mMU/mL
Interval 2335.4 to 4428.8
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Anti-HPV 6 (N=11, N=21, N=22)
|
1273.3 mMU/mL
Interval 704.9 to 2300.1
|
2203.0 mMU/mL
Interval 1658.9 to 2925.6
|
4784.7 mMU/mL
Interval 3741.5 to 6118.8
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Anti-HPV 11 (N=11, N=21, N=22)
|
1991.6 mMU/mL
Interval 1096.3 to 3618.2
|
2564.3 mMU/mL
Interval 1940.8 to 3388.3
|
3921.6 mMU/mL
Interval 2964.4 to 5188.0
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
Anti-HPV 31(N=11, N=24, N=23)
|
24.3 mMU/mL
Interval to 79.1
The lower bound of the 95% confidence interval is below the level of detectability (\<8).
|
2037.5 mMU/mL
Interval 1502.4 to 2763.0
|
4782.3 mMU/mL
Interval 3282.4 to 6967.5
|
PRIMARY outcome
Timeframe: 4 weeks postdose 3 (Phase B)Population: PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Outcome measures
| Measure |
qHPV (GARDASIL™) - Phase A Control
n=15 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
|
Octavalent HPV With 15 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
|
Octavalent HPV With 30 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
Anti-HPV Type 6 (N=10, N=19, N=23)
|
2350.9 mMU/mL
Interval 1581.6 to 3494.2
|
6006.0 mMU/mL
Interval 3991.6 to 9037.0
|
4484.8 mMU/mL
Interval 2791.7 to 7204.7
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
Anti-HPV Type 11 (N=10, N=19, N=23)
|
3762.2 mMU/mL
Interval 2422.0 to 5844.1
|
6514.2 mMU/mL
Interval 4520.8 to 9386.8
|
6609.3 mMU/mL
Interval 5028.2 to 8687.5
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
Anti-HPV Type 16 (N=7, N=19, N=20)
|
2783.6 mMU/mL
Interval 973.2 to 7961.8
|
12947.5 mMU/mL
Interval 8856.5 to 18928.3
|
10105.9 mMU/mL
Interval 6570.9 to 15542.6
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
Anti-HPV Type 18 (N=10, N=19, N=25)
|
948.2 mMU/mL
Interval 403.7 to 2227.1
|
5090.0 mMU/mL
Interval 3467.5 to 7471.7
|
4070.9 mMU/mL
Interval 3135.2 to 5285.9
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
Anti-HPV Type 45 (N=11, N=20, N=24)
|
4.7 mMU/mL
Interval to 10.9
The lower bound of the 95% confidence interval is below the level of detectability (\<4).
|
3974.8 mMU/mL
Interval 2680.5 to 5894.0
|
4696.4 mMU/mL
Interval 3499.6 to 6302.5
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
Anti-HPV Type 31 (N=11, N=22, N=24)
|
36.9 mMU/mL
Interval 15.5 to 88.2
|
7779.0 mMU/mL
Interval 4876.7 to 12408.5
|
5487.3 mMU/mL
Interval 3683.0 to 8175.6
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
Anti-HPV Type 52 (N=10, N=20, N=23)
|
NA mMU/mL
The GMT is \<16, and the lower and upper bounds of the 95% confidence interval are below the level of detectability (\<16 to \<16).
|
5714.9 mMU/mL
Interval 3962.4 to 8242.6
|
6624.6 mMU/mL
Interval 4919.9 to 8919.9
|
|
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
Anti-HPV Type 58 (N=9, N=21, N=24)
|
9.6 mMU/mL
Interval to 28.1
The lower bound of the 95% confidence interval is below the level of detectability (\<6).
|
4961.8 mMU/mL
Interval 3170.1 to 7766.1
|
5191.2 mMU/mL
Interval 4036.3 to 6676.5
|
PRIMARY outcome
Timeframe: 4 weeks postdose 3 (Phase A)Population: PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
Outcome measures
| Measure |
qHPV (GARDASIL™) - Phase A Control
n=15 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
|
Octavalent HPV With 15 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
|
Octavalent HPV With 30 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
|
|---|---|---|---|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
Anti-HPV 6 (N=11, N=21, N=22)
|
11 Participants
|
21 Participants
|
22 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
Anti-HPV 11 (N=11, N=21, N=22)
|
11 Participants
|
21 Participants
|
22 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
Anti-HPV 16 (N=11, N=23, N=24)
|
11 Participants
|
23 Participants
|
24 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
Anti-HPV 18 (N=11, N=24, N=24)
|
11 Participants
|
24 Participants
|
24 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
Anti-HPV 31 (N=11, N=24, N=23)
|
6 Participants
|
24 Participants
|
23 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
Anti-HPV 45 (N=11, N=26, N=25)
|
4 Participants
|
26 Participants
|
25 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
Anti-HPV 52 (N=9, N=23, N=25)
|
0 Participants
|
23 Participants
|
25 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
Anti-HPV 58 (N=10, N=24, N=22)
|
3 Participants
|
24 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 4 weeks postdose 3 (Phase B)Population: PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
Outcome measures
| Measure |
qHPV (GARDASIL™) - Phase A Control
n=15 Participants
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
|
Octavalent HPV With 15 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
|
Octavalent HPV With 30 mcg IMX / AAHS
n=30 Participants
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
|
|---|---|---|---|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
Anti-HPV 18 (N=10, N=19, N=25)
|
10 Participants
|
19 Participants
|
25 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
Anti-HPV 6 (N=10, N=19, N=23)
|
10 Participants
|
19 Participants
|
23 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
Anti-HPV 11 (N=10, N=19, N=23)
|
10 Participants
|
19 Participants
|
23 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
Anti-HPV 16 (N=7, N=19, N=20)
|
7 Participants
|
19 Participants
|
20 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
Anti-HPV 31 (N=11, N=22, N=24)
|
9 Participants
|
22 Participants
|
24 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
Anti-HPV 45 (N=11, N=20, N=24)
|
2 Participants
|
20 Participants
|
24 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
Anti-HPV 52 (N=10, N=20, N=23)
|
0 Participants
|
20 Participants
|
23 Participants
|
|
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
Anti-HPV 58 (N=9, N=21, N=24)
|
2 Participants
|
21 Participants
|
24 Participants
|
Adverse Events
qHPV (GARDASIL™) - Phase A and Phase B Controls
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Octavalent HPV With 15 mcg IMX / AAHS
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Octavalent HPV With 30 mcg IMX / AAHS
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Octavalent HPV With 60 mcg IMX / AAHS
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Octavalent With 120 mcg IMX / AAHS
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
qHPV (GARDASIL™) - Phase A and Phase B Controls
n=30 participants at risk
Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) combined from Phase A and Phase B.
|
Octavalent HPV With 15 mcg IMX / AAHS
n=30 participants at risk
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 15 mcg IMX.
|
Octavalent HPV With 30 mcg IMX / AAHS
n=30 participants at risk
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 30 mcg IMX.
|
Octavalent HPV With 60 mcg IMX / AAHS
n=30 participants at risk
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 60 mcg IMX.
|
Octavalent With 120 mcg IMX / AAHS
n=30 participants at risk
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 120 mcg IMX.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
16.7%
5/30 • Number of events 6 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
6/30 • Number of events 7 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
20.0%
6/30 • Number of events 11 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
20.0%
6/30 • Number of events 6 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
30.0%
9/30 • Number of events 10 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Axillary pain
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 5 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Chills
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Fatigue
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Injection site erythema
|
40.0%
12/30 • Number of events 21 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
50.0%
15/30 • Number of events 18 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
53.3%
16/30 • Number of events 27 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
70.0%
21/30 • Number of events 36 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
66.7%
20/30 • Number of events 38 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Injection site haematoma
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
23.3%
7/30 • Number of events 7 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 5 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Injection site induration
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 6 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
16.7%
5/30 • Number of events 8 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
16.7%
5/30 • Number of events 10 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
16.7%
5/30 • Number of events 6 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Injection site mass
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 5 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Injection site pain
|
90.0%
27/30 • Number of events 62 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
96.7%
29/30 • Number of events 94 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
100.0%
30/30 • Number of events 101 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
100.0%
30/30 • Number of events 95 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
100.0%
30/30 • Number of events 89 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Injection site pruritus
|
10.0%
3/30 • Number of events 5 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 6 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
16.7%
5/30 • Number of events 7 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
16.7%
5/30 • Number of events 7 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Injection site swelling
|
23.3%
7/30 • Number of events 14 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
50.0%
15/30 • Number of events 22 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
73.3%
22/30 • Number of events 37 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
80.0%
24/30 • Number of events 48 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
73.3%
22/30 • Number of events 43 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Injection site warmth
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Pain
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
General disorders
Pyrexia
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
16.7%
5/30 • Number of events 5 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
40.0%
12/30 • Number of events 15 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
3/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
16.7%
5/30 • Number of events 5 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Infections and infestations
Viral infection
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 7 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 5 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Nervous system disorders
Dizziness
|
13.3%
4/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 5 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Nervous system disorders
Headache
|
40.0%
12/30 • Number of events 22 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
33.3%
10/30 • Number of events 16 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
53.3%
16/30 • Number of events 29 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
50.0%
15/30 • Number of events 30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
63.3%
19/30 • Number of events 46 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
0.00%
0/30 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
6/30 • Number of events 7 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
23.3%
7/30 • Number of events 7 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
10.0%
3/30 • Number of events 3 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
13.3%
4/30 • Number of events 4 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
6.7%
2/30 • Number of events 2 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
3.3%
1/30 • Number of events 1 • All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
|
Additional Information
Senior Vice President,Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee As this study is part of a multicenter trial, the SPONSOR does not recommend separate publication of individual study site results due to scientific concerns. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER