Trial Outcomes & Findings for Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India (NCT NCT00923702)
NCT ID: NCT00923702
Last Updated: 2023-09-28
Results Overview
Samples were treated with EDTA and analysed with Luminex (Austin, TX, USA) based multiplex serology to assess the concentration of binding antibodies against the major capsid protein L1 as mean median fluorescence intensity (MFI). MFI values as a measure of antibody concentration quantified by use of HPV multiplex serology are directly comparable with optical densities measured with ELISA.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE4
Target enrollment
22729 participants
Primary outcome timeframe
Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
3-dose
The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2-dose
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2 Doses by Default
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Single-dose
The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Unvaccinated
A cohort of unvaccinated women
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4348
|
4979
|
3452
|
4950
|
5000
|
|
Overall Study
COMPLETED
|
4348
|
4979
|
3452
|
4950
|
4646
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
354
|
Reasons for withdrawal
| Measure |
3-dose
The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2-dose
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2 Doses by Default
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Single-dose
The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Unvaccinated
A cohort of unvaccinated women
|
|---|---|---|---|---|---|
|
Overall Study
Ongoing enrollment
|
0
|
0
|
0
|
0
|
354
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
3-dose
n=4348 Participants
The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2-dose
n=4979 Participants
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2 Doses by Default
n=3452 Participants
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Single-dose
n=4950 Participants
The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Unvaccinated
n=4646 Participants
A cohort of unvaccinated women
|
Total
n=22375 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
13.5 years
STANDARD_DEVIATION 2.3 • n=4348 Participants
|
13.6 years
STANDARD_DEVIATION 2.3 • n=4979 Participants
|
13.7 years
STANDARD_DEVIATION 2.4 • n=3452 Participants
|
13.7 years
STANDARD_DEVIATION 2.4 • n=4950 Participants
|
24.1 years
STANDARD_DEVIATION 2.9 • n=4646 Participants
|
15.8 years
STANDARD_DEVIATION 4.9 • n=22375 Participants
|
|
Sex: Female, Male
Female
|
4348 Participants
n=4348 Participants
|
4979 Participants
n=4979 Participants
|
3452 Participants
n=3452 Participants
|
4950 Participants
n=4950 Participants
|
4646 Participants
n=4646 Participants
|
22375 Participants
n=22375 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4348 Participants
|
0 Participants
n=4979 Participants
|
0 Participants
n=3452 Participants
|
0 Participants
n=4950 Participants
|
0 Participants
n=4646 Participants
|
0 Participants
n=22375 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Enrolment
|
4348 Participants
n=4348 Participants
|
4979 Participants
n=4979 Participants
|
3452 Participants
n=3452 Participants
|
4950 Participants
n=4950 Participants
|
4646 Participants
n=4646 Participants
|
22375 Participants
n=22375 Participants
|
PRIMARY outcome
Timeframe: Month 7 (for 3-dose and 2-dose groups), 12 (for 2 doses by default and single-dose groups), 18, 36, 48Population: Data used for this outcome are from a subset of participants that had their immunogeneicity samples tested in the laboratory. We are indicating the total of HPV 16 L1 antibodies of the HPV 16 L1 antiboties at month 7 for the 3-dose and 2-dose groups and at month 12 for the 2 doses by default and single-dose groups. No immunogeneity data was collected from the unvaccinated cohort as it was recruited adhoc to assess the HPV infections and CIN endpoints.
Samples were treated with EDTA and analysed with Luminex (Austin, TX, USA) based multiplex serology to assess the concentration of binding antibodies against the major capsid protein L1 as mean median fluorescence intensity (MFI). MFI values as a measure of antibody concentration quantified by use of HPV multiplex serology are directly comparable with optical densities measured with ELISA.
Outcome measures
| Measure |
3-dose
n=308 Participants
The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2-dose
n=317 Participants
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2 Doses by Default
n=471 Participants
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Single-dose
n=528 Participants
The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Unvaccinated
A cohort of unvaccinated women
|
|---|---|---|---|---|---|
|
Median Florescent Intensities (MFI) of the Total Antibodies to Vaccine-included HPV Types (16/18/6/11) at Different Time Points
|
5460 median flow intensities
Interval 5195.0 to 5738.0
|
6125 median flow intensities
Interval 5785.0 to 6485.0
|
437 median flow intensities
Interval 398.0 to 480.0
|
106 median flow intensities
Interval 96.0 to 116.0
|
—
|
PRIMARY outcome
Timeframe: From date of marriage through to 7 years of follow-upPopulation: Participants with at least two cervical cell sample collections, that were collected at least 10 months apart.
The first cervical cell samples were collected from women 18 months after married or 6 months after the first delivery. After that, 3 extra annual collections were obtained. The HPV genotyping method involved HPV-type-specific E7 PCR bead-based multiplex genotyping. The multiplex HPV-type-specific E7 PCR uses HPV type-specific primers targeting the E7 region for the detection of 19 high-risk or probable high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68a, 68b, 70, 73, and 82), and two low-risk HPV types (6 and 11), with detection limits ranging from ten to 1000 copies of the viral genome.
Outcome measures
| Measure |
3-dose
n=1460 Participants
The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2-dose
n=1452 Participants
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2 Doses by Default
n=1626 Participants
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Single-dose
n=2135 Participants
The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Unvaccinated
n=1265 Participants
A cohort of unvaccinated women
|
|---|---|---|---|---|---|
|
Frequency of Persistent HPV 16/18/6/11 Infection.
|
1 Infections
|
1 Infections
|
4 Infections
|
1 Infections
|
32 Infections
|
PRIMARY outcome
Timeframe: Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screenPathology Panel diagnosis of: CIN 2, CIN 3 (including squamous carcinoma in situ), adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix and detection of HPV 16 and/or HPV 18 by PCR in the same biopsy tissue sample.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cervical samples for HPV testing collected from married participants at the age of 25 and at 5 years after the first screenThe HPV genotyping method involved HPV-type-specific E7 PCR bead-based multiplex genotyping. The multiplex HPV-type-specific E7 PCR uses HPV type-specific primers targeting the E7 region for the detection of 19 high-risk or probable high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68a, 68b, 70, 73, and 82), and two low-risk HPV types (6 and 11), with detection limits ranging from ten to 1000 copies of the viral genome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 15 years from the base-line datePathology Panel diagnosis of: CIN 2, CIN 3 (including squamous carcinoma in situ), adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix and detection of other non vaccine included HPV types by PCR in the same biopsy tissue sample.
Outcome measures
Outcome data not reported
Adverse Events
3-dose
Serious events: 125 serious events
Other events: 637 other events
Deaths: 30 deaths
2-dose
Serious events: 135 serious events
Other events: 614 other events
Deaths: 22 deaths
2 Doses by Default
Serious events: 292 serious events
Other events: 614 other events
Deaths: 38 deaths
Single-dose
Serious events: 356 serious events
Other events: 296 other events
Deaths: 45 deaths
Unvaccinated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
3-dose
n=4348 participants at risk
The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2-dose
n=4979 participants at risk
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2 Doses by Default
n=3452 participants at risk
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Single-dose
n=4950 participants at risk
The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Unvaccinated
n=4646 participants at risk
A cohort of unvaccinated women
|
|---|---|---|---|---|---|
|
Investigations
Hospitalization
|
0.32%
14/4348 • Number of events 14 • 7 years
|
0.52%
26/4979 • Number of events 26 • 7 years
|
0.58%
20/3452 • Number of events 20 • 7 years
|
0.53%
26/4950 • Number of events 26 • 7 years
|
0.00%
0/4646 • 7 years
|
|
Pregnancy, puerperium and perinatal conditions
Abortion/Gynecological conditions
|
2.2%
94/4348 • Number of events 94 • 7 years
|
1.8%
92/4979 • Number of events 92 • 7 years
|
6.2%
214/3452 • Number of events 214 • 7 years
|
4.8%
239/4950 • Number of events 239 • 7 years
|
0.00%
0/4646 • 7 years
|
|
Pregnancy, puerperium and perinatal conditions
Preterm delivery
|
0.28%
12/4348 • Number of events 12 • 7 years
|
0.22%
11/4979 • Number of events 11 • 7 years
|
0.81%
28/3452 • Number of events 28 • 7 years
|
0.81%
40/4950 • Number of events 40 • 7 years
|
0.00%
0/4646 • 7 years
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal death
|
0.11%
5/4348 • Number of events 5 • 7 years
|
0.12%
6/4979 • Number of events 6 • 7 years
|
0.87%
30/3452 • Number of events 30 • 7 years
|
1.0%
51/4950 • Number of events 51 • 7 years
|
0.00%
0/4646 • 7 years
|
Other adverse events
| Measure |
3-dose
n=4348 participants at risk
The participants received three doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1, 60 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2-dose
n=4979 participants at risk
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 180+.
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
2 Doses by Default
n=3452 participants at risk
The participants received two doses of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) at days 1 and 60 by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Single-dose
n=4950 participants at risk
The participants received one dose of the Prophylactic quadrivalent HPV vaccine Merck (Gardasil®) by default (incomplete doses)
Prophylactic quadrivalent HPV vaccine Merck (Gardasil®): The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
|
Unvaccinated
n=4646 participants at risk
A cohort of unvaccinated women
|
|---|---|---|---|---|---|
|
General disorders
Mild: Abdominal cramps
|
0.11%
5/4348 • Number of events 5 • 7 years
|
0.10%
5/4979 • Number of events 5 • 7 years
|
0.06%
2/3452 • Number of events 2 • 7 years
|
0.06%
3/4950 • Number of events 3 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Diarrhea
|
0.11%
5/4348 • Number of events 5 • 7 years
|
0.18%
9/4979 • Number of events 9 • 7 years
|
0.09%
3/3452 • Number of events 3 • 7 years
|
0.04%
2/4950 • Number of events 2 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Discomfort
|
0.07%
3/4348 • Number of events 3 • 7 years
|
0.02%
1/4979 • Number of events 1 • 7 years
|
0.06%
2/3452 • Number of events 2 • 7 years
|
0.02%
1/4950 • Number of events 1 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Dizziness
|
0.41%
18/4348 • Number of events 18 • 7 years
|
0.42%
21/4979 • Number of events 21 • 7 years
|
0.64%
22/3452 • Number of events 22 • 7 years
|
0.20%
10/4950 • Number of events 10 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Fainting (vaso vagal reaction) within 15 to 20 minutes of vaccine receipt
|
0.09%
4/4348 • Number of events 4 • 7 years
|
0.12%
6/4979 • Number of events 6 • 7 years
|
0.00%
0/3452 • 7 years
|
0.04%
2/4950 • Number of events 2 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Fatigue
|
0.02%
1/4348 • Number of events 1 • 7 years
|
0.02%
1/4979 • Number of events 1 • 7 years
|
0.00%
0/3452 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Injection site pain
|
7.9%
344/4348 • Number of events 344 • 7 years
|
6.8%
341/4979 • Number of events 341 • 7 years
|
10.2%
352/3452 • Number of events 352 • 7 years
|
2.8%
137/4950 • Number of events 137 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Joint stiffness
|
0.00%
0/4348 • 7 years
|
0.02%
1/4979 • Number of events 1 • 7 years
|
0.03%
1/3452 • Number of events 1 • 7 years
|
0.02%
1/4950 • Number of events 1 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Low-grade fever (< 39°C sublingual) measurement)
|
2.0%
88/4348 • Number of events 88 • 7 years
|
1.6%
80/4979 • Number of events 80 • 7 years
|
2.8%
96/3452 • Number of events 96 • 7 years
|
1.5%
76/4950 • Number of events 76 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Malaise
|
0.00%
0/4348 • 7 years
|
0.00%
0/4979 • 7 years
|
0.03%
1/3452 • Number of events 1 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: headaches
|
0.62%
27/4348 • Number of events 27 • 7 years
|
0.36%
18/4979 • Number of events 18 • 7 years
|
0.52%
18/3452 • Number of events 18 • 7 years
|
0.16%
8/4950 • Number of events 8 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: injection site swelling
|
0.94%
41/4348 • Number of events 41 • 7 years
|
0.52%
26/4979 • Number of events 26 • 7 years
|
1.7%
58/3452 • Number of events 58 • 7 years
|
0.44%
22/4950 • Number of events 22 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: irritability
|
0.00%
0/4348 • 7 years
|
0.00%
0/4979 • 7 years
|
0.06%
2/3452 • Number of events 2 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: muscle pain
|
0.00%
0/4348 • 7 years
|
0.02%
1/4979 • Number of events 1 • 7 years
|
0.03%
1/3452 • Number of events 1 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Muscle spasms
|
0.00%
0/4348 • 7 years
|
0.00%
0/4979 • 7 years
|
0.00%
0/3452 • 7 years
|
0.02%
1/4950 • Number of events 1 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Nausea
|
0.34%
15/4348 • Number of events 15 • 7 years
|
0.18%
9/4979 • Number of events 9 • 7 years
|
0.17%
6/3452 • Number of events 6 • 7 years
|
0.06%
3/4950 • Number of events 3 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Neck pain
|
0.00%
0/4348 • 7 years
|
0.04%
2/4979 • Number of events 2 • 7 years
|
0.00%
0/3452 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Pain in extremity
|
0.05%
2/4348 • Number of events 2 • 7 years
|
0.10%
5/4979 • Number of events 5 • 7 years
|
0.00%
0/3452 • 7 years
|
0.12%
6/4950 • Number of events 6 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Rash
|
0.00%
0/4348 • 7 years
|
0.06%
3/4979 • Number of events 3 • 7 years
|
0.23%
8/3452 • Number of events 8 • 7 years
|
0.08%
4/4950 • Number of events 4 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Redness, mild tenderness or bruising around the injection site
|
0.02%
1/4348 • Number of events 1 • 7 years
|
0.06%
3/4979 • Number of events 3 • 7 years
|
0.00%
0/3452 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Sensation of heaviness
|
0.02%
1/4348 • Number of events 1 • 7 years
|
0.02%
1/4979 • Number of events 1 • 7 years
|
0.00%
0/3452 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Shoulder pain
|
0.02%
1/4348 • Number of events 1 • 7 years
|
0.02%
1/4979 • Number of events 1 • 7 years
|
0.00%
0/3452 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Skin irritation
|
0.05%
2/4348 • Number of events 2 • 7 years
|
0.08%
4/4979 • Number of events 4 • 7 years
|
0.09%
3/3452 • Number of events 3 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Mild: Other specify
|
1.2%
52/4348 • Number of events 52 • 7 years
|
1.1%
53/4979 • Number of events 53 • 7 years
|
0.55%
19/3452 • Number of events 19 • 7 years
|
0.20%
10/4950 • Number of events 10 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Moderate: Allergic reaction [Characterized by one or more of the following: (1) skin manifestations
|
0.05%
2/4348 • Number of events 2 • 7 years
|
0.00%
0/4979 • 7 years
|
0.00%
0/3452 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Moderate: Allergic skin reactions
|
0.02%
1/4348 • Number of events 1 • 7 years
|
0.00%
0/4979 • 7 years
|
0.03%
1/3452 • Number of events 1 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Moderate: Facial edema
|
0.00%
0/4348 • 7 years
|
0.00%
0/4979 • 7 years
|
0.03%
1/3452 • Number of events 1 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Moderate: High fevers sometimes associated with seizures (> 39° C)
|
0.07%
3/4348 • Number of events 3 • 7 years
|
0.10%
5/4979 • Number of events 5 • 7 years
|
0.26%
9/3452 • Number of events 9 • 7 years
|
0.06%
3/4950 • Number of events 3 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Moderate: Larger reactions (> 2 cm) around the injection site
|
0.00%
0/4348 • 7 years
|
0.02%
1/4979 • Number of events 1 • 7 years
|
0.03%
1/3452 • Number of events 1 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Moderate: Temporary joint pain or swelling
|
0.00%
0/4348 • 7 years
|
0.00%
0/4979 • 7 years
|
0.03%
1/3452 • Number of events 1 • 7 years
|
0.00%
0/4950 • 7 years
|
0.00%
0/4646 • 7 years
|
|
General disorders
Moderate: Other specify
|
0.48%
21/4348 • Number of events 21 • 7 years
|
0.34%
17/4979 • Number of events 17 • 7 years
|
0.20%
7/3452 • Number of events 7 • 7 years
|
0.14%
7/4950 • Number of events 7 • 7 years
|
0.00%
0/4646 • 7 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place