Trial Outcomes & Findings for Gardasil Immunogenicity With Needle-Free Injection (NCT NCT01924754)
NCT ID: NCT01924754
Last Updated: 2021-10-13
Results Overview
Geometric mean antibody concentrations above the lower limit of assay detection at baseline were assessed by HPV type
Recruitment status
COMPLETED
Target enrollment
150 participants
Primary outcome timeframe
Baseline, up to 1 day
Results posted on
2021-10-13
Participant Flow
161 women visiting the Thai Red Cross Anonymous Clinic between February 2014 and April 2014 were invited to participate in the study and were screened after providing informed consent. Eleven women were determined to be ineligible
Participant milestones
| Measure |
Standard Intramuscular Injection (NS-IM)
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
Standard Intramuscular Injection (NS-IM)
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
2
|
Baseline Characteristics
Gardasil Immunogenicity With Needle-Free Injection
Baseline characteristics by cohort
| Measure |
Standard Intramuscular Injection (NS-IM)
n=50 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=50 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=50 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.3 years
n=5 Participants
|
23.4 years
n=7 Participants
|
24.5 years
n=5 Participants
|
23.7 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
150 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Thailand
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
50 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Positive cervical HPV DNA at Baseline
HPV-6
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Positive cervical HPV DNA at Baseline
HPV-11
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Positive cervical HPV DNA at Baseline
HPV-16
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Positive cervical HPV DNA at Baseline
HPV-18
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Number of HPV genotypes detected at Baseline
1 type
|
18 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Number of HPV genotypes detected at Baseline
2 types
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Number of HPV genotypes detected at Baseline
>= 3 types
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 1 dayGeometric mean antibody concentrations above the lower limit of assay detection at baseline were assessed by HPV type
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=50 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=50 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=50 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type
HPV-6
|
15 Participants
|
12 Participants
|
8 Participants
|
|
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type
HPV-11
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type
HPV-16
|
14 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With Geometric Mean Antibody Concentrations by HPV Type
HPV-18
|
6 Participants
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 7 monthsThe percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 6 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=32 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=36 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=38 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Percentage of Participants With a Demonstrated Seroconversion for HPV 6
|
100 percentage of participants
|
97.2 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 7 monthsThe percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 11 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=45 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=45 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=43 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Percentage of Participants With a Demonstrated Seroconversion for HPV 11
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 7 monthsThe percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 16 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=31 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=39 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=39 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Percentage of Participants With a Demonstrated Seroconversion for HPV 16
|
100 percentage of participants
|
97.4 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 7 monthsThe percentage of participants with demonstrated seroconversion generated following a 3-dose series of vaccine for antibodies to HPV 18 at month 7 for the per-protocol efficacy population. The per-protocol efficacy population is defined as as those with month 7 result available, geometric mean antibody concentration below the cutoff level for positivity and undetectable baseline cervical HPV DNA.
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=42 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=42 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=42 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Percentage of Participants With a Demonstrated Seroconversion for HPV 18
|
100 percentage of participants
|
97.6 percentage of participants
|
97.6 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 7 monthsThe median (mMU/mL) for HPV 6 at month 7 for the intent to treat population was calculated
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=50 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=50 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=50 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Median Concentration for HPV 6 Over Time
Baseline
|
11 mMU/mL
Interval 11.0 to 15.0
|
11 mMU/mL
Interval 11.0 to 11.0
|
11 mMU/mL
Interval 11.0 to 11.0
|
|
Median Concentration for HPV 6 Over Time
Month 7
|
449.5 mMU/mL
Interval 271.0 to 750.0
|
311 mMU/mL
Interval 247.0 to 665.0
|
259.5 mMU/mL
Interval 146.0 to 395.0
|
PRIMARY outcome
Timeframe: Up to 7 monthsThe median concentration (mMU/mL) for HPV 11 at month 7 for the intent to treat population was calculated
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=50 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=50 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=50 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Median Concentration for HPV 11 Over Time
Baseline
|
8 mMU/mL
Interval 8.0 to 8.0
|
8 mMU/mL
Interval 8.0 to 8.0
|
8 mMU/mL
Interval 8.0 to 8.0
|
|
Median Concentration for HPV 11 Over Time
Month 7
|
517.5 mMU/mL
Interval 334.0 to 769.0
|
484 mMU/mL
Interval 249.0 to 772.0
|
387 mMU/mL
Interval 197.0 to 518.0
|
PRIMARY outcome
Timeframe: Up to 7 monthsThe median concentration (mMU/mL) for HPV 16 at month 7 for the intent to treat population was calculated
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=50 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=50 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=50 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Median Concentration for HPV 16 Over Time
Baseline
|
11 mMU/mL
Interval 11.0 to 26.0
|
11 mMU/mL
Interval 11.0 to 11.0
|
11 mMU/mL
Interval 11.0 to 11.0
|
|
Median Concentration for HPV 16 Over Time
Month 7
|
2243.5 mMU/mL
Interval 1669.0 to 4227.0
|
2054.5 mMU/mL
Interval 1297.0 to 3332.0
|
1482 mMU/mL
Interval 730.0 to 2584.0
|
PRIMARY outcome
Timeframe: Up to 7 monthsThe median concentration (mMU/mL) for HPV 18 at month 7 for the intent to treat population was calculated
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=50 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=50 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=50 Participants
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Median Concentration for HPV 18 Over Time
Baseline
|
10 mMU/mL
Interval 10.0 to 10.0
|
10 mMU/mL
Interval 10.0 to 10.0
|
10 mMU/mL
Interval 10.0 to 10.0
|
|
Median Concentration for HPV 18 Over Time
Month 7
|
412.5 mMU/mL
Interval 193.0 to 768.0
|
414.5 mMU/mL
Interval 166.0 to 610.0
|
372.5 mMU/mL
Interval 142.0 to 578.0
|
PRIMARY outcome
Timeframe: Up to 7 monthsThe Geometric Mean Concentration Ratio (GMCR) and 95% confidence interval for both NS-IM versus JI-IM and NS-IM versus JI-ID was computed for the intent to treat population. Non-inferiority for arms JI-IM and JI-ID was defined as geometric mean concentration ratio (GMCR) \<1.5 of NS-IM at month 7
Outcome measures
| Measure |
Standard Intramuscular Injection (NS-IM)
n=50 Participants
Human papillomavirus (HPV) vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=50 Participants
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type
HPV-6
|
1.37 ratio
Interval 0.9 to 2.08
|
1.84 ratio
Interval 1.3 to 2.61
|
—
|
|
Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type
HPV-11
|
1.36 ratio
Interval 0.94 to 1.96
|
1.61 ratio
Interval 1.19 to 2.17
|
—
|
|
Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type
HPV-16
|
1.47 ratio
Interval 0.97 to 2.24
|
1.97 ratio
Interval 1.34 to 2.9
|
—
|
|
Geometric Mean Concentration Ratio of NS-IM Versus the PharmaJet Groups by HPV Type
HPV-18
|
1.23 ratio
Interval 0.79 to 1.91
|
1.52 ratio
Interval 0.99 to 2.33
|
—
|
Adverse Events
Standard Intramuscular Injection (NS-IM)
Serious events: 2 serious events
Other events: 45 other events
Deaths: 0 deaths
PharmaJet Needle-free Stratis Device (JI-IM)
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
PharmaJet Needle-free Tropis Device (JI-ID)
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Intramuscular Injection (NS-IM)
n=50 participants at risk
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=50 participants at risk
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=50 participants at risk
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
2.0%
1/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
4.0%
2/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
2.0%
1/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
2.0%
1/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
2.0%
1/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
Other adverse events
| Measure |
Standard Intramuscular Injection (NS-IM)
n=50 participants at risk
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by standard intramuscular (IM) injection using a needle and syringe
|
PharmaJet Needle-free Stratis Device (JI-IM)
n=50 participants at risk
HPV vaccination regimen: Standard 3 dose (0.5mL) delivered by IM injection using the PharmaJet needle-free Stratis device
|
PharmaJet Needle-free Tropis Device (JI-ID)
n=50 participants at risk
HPV vaccination regimen: Reduced-dose (0.1 mL) delivered by intradermal injection using the PharmaJet needle-free Tropis device
|
|---|---|---|---|
|
Investigations
Injection site pain
|
88.0%
44/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
88.0%
44/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
46.0%
23/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Investigations
Swelling
|
42.0%
21/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
64.0%
32/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
42.0%
21/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Arm movement limitation
|
70.0%
35/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
66.0%
33/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
18.0%
9/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Investigations
Erythema
|
28.0%
14/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
46.0%
23/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
54.0%
27/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Itching
|
12.0%
6/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
28.0%
14/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
30.0%
15/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Investigations
Induration
|
14.0%
7/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
40.0%
20/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
54.0%
27/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
18.0%
9/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
18.0%
9/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
14.0%
7/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Nervous system disorders
Headache
|
30.0%
15/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
22.0%
11/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
8.0%
4/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
General disorders
Chills
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
6.0%
3/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
0.00%
0/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Nervous system disorders
Dizziness
|
24.0%
12/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
28.0%
14/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
12.0%
6/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
General disorders
Fatigue
|
52.0%
26/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
40.0%
20/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
18.0%
9/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Gastrointestinal disorders
Nausea
|
12.0%
6/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
8.0%
4/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
2.0%
1/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
56.0%
28/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
62.0%
31/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
12.0%
6/50 • Up to 7 months
Immediate complaints (noted within 30 minutes after vaccination), solicited adverse events (local and systemic) from the first day after vaccination until 7 days after the vaccination as reported on diary cards, and unsolicited reported adverse events during the study
|
Additional Information
Dr. Joel Palefsky, MD
University of California, San Francisco
Phone: (415) 476-8885
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place