Trial Outcomes & Findings for Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors (NCT NCT01492582)
NCT ID: NCT01492582
Last Updated: 2021-10-27
Results Overview
The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1499 participants
Primary outcome timeframe
At baseline
Results posted on
2021-10-27
Participant Flow
Participant milestones
| Measure |
Prevention (Vaccine Therapy)
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
laboratory biomarker analysis: Correlative studies
survey administration: Ancillary studies
medical chart review: Ancillary studies
|
Survey Arm
Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.
|
|---|---|---|
|
Overall Study
STARTED
|
453
|
1046
|
|
Overall Study
Received First Quadrivalent Vaccine Dose
|
254
|
0
|
|
Overall Study
Received First Nonavalent Vaccine Dose
|
182
|
0
|
|
Overall Study
COMPLETED
|
384
|
982
|
|
Overall Study
NOT COMPLETED
|
69
|
64
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Baseline characteristics by cohort
| Measure |
Prevention (Vaccine Therapy)
n=453 Participants
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Survey
n=1046 Participants
Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.
|
Total
n=1499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
9-15 years
|
249 Participants
n=5 Participants
|
508 Participants
n=7 Participants
|
757 Participants
n=5 Participants
|
|
Age, Customized
16-26 years
|
204 Participants
n=5 Participants
|
538 Participants
n=7 Participants
|
742 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
195 Participants
n=5 Participants
|
473 Participants
n=7 Participants
|
668 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
258 Participants
n=5 Participants
|
573 Participants
n=7 Participants
|
831 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
400 Participants
n=5 Participants
|
900 Participants
n=7 Participants
|
1300 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
96 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
338 Participants
n=5 Participants
|
796 Participants
n=7 Participants
|
1134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
453 participants
n=5 Participants
|
1046 participants
n=7 Participants
|
1499 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baselinePopulation: Participants who returned an evaluable survey
The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
Outcome measures
| Measure |
Survey Participants
n=982 Participants
Participants who consented to the survey aim of the study.
|
Quadrivalent Anti-HPV 16, Female, Age 9-15 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 16, Male, Age 16-26 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 16, Female, Age 16-26 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Male, Age 9-15 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Female, Age 9-15 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Male, Age 16-26 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Female, Age 16-26 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Male, Age 9-15 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Female, Age 9-15 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Male, Age 16-26 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Female, Age 16-26 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Male, Age 9-15 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Female, Age 9-15 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Male, Age 16-26 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Female, Age 16-26 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])
|
179 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month following vaccination dose #3To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.
Outcome measures
| Measure |
Survey Participants
n=65 Participants
Participants who consented to the survey aim of the study.
|
Quadrivalent Anti-HPV 16, Female, Age 9-15 Years
n=51 Participants
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 16, Male, Age 16-26 Years
n=65 Participants
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 16, Female, Age 16-26 Years
n=28 Participants
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Male, Age 9-15 Years
n=53 Participants
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Female, Age 9-15 Years
n=41 Participants
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Male, Age 16-26 Years
n=32 Participants
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Female, Age 16-26 Years
n=23 Participants
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Male, Age 9-15 Years
n=66 Participants
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Female, Age 9-15 Years
n=54 Participants
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Male, Age 16-26 Years
n=68 Participants
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Female, Age 16-26 Years
n=30 Participants
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Male, Age 9-15 Years
n=50 Participants
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Female, Age 9-15 Years
n=41 Participants
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Male, Age 16-26 Years
n=32 Participants
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Female, Age 16-26 Years
n=28 Participants
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])
|
16134.57 mMu/mL
Standard Deviation 14722.06
|
15209.73 mMu/mL
Standard Deviation 15638.30
|
8740.02 mMu/mL
Standard Deviation 9625.61
|
6107.32 mMu/mL
Standard Deviation 6609.07
|
16419.64 mMu/mL
Standard Deviation 14756.37
|
11763.60 mMu/mL
Standard Deviation 8082.14
|
10770.38 mMu/mL
Standard Deviation 11166.73
|
11522.87 mMu/mL
Standard Deviation 10443.38
|
3472.21 mMu/mL
Standard Deviation 3769.68
|
2638.33 mMu/mL
Standard Deviation 2695.70
|
1920.01 mMu/mL
Standard Deviation 2553.81
|
1009.90 mMu/mL
Standard Deviation 990.48
|
5599.80 mMu/mL
Standard Deviation 4522.19
|
3457.20 mMu/mL
Standard Deviation 2510.32
|
3013.39 mMu/mL
Standard Deviation 3194.84
|
3483.29 mMu/mL
Standard Deviation 6869.27
|
PRIMARY outcome
Timeframe: Dose 1 through Month 7Population: Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population.
Outcome measures
| Measure |
Survey Participants
n=253 Participants
Participants who consented to the survey aim of the study.
|
Quadrivalent Anti-HPV 16, Female, Age 9-15 Years
n=182 Participants
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 16, Male, Age 16-26 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 16, Female, Age 16-26 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Male, Age 9-15 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Female, Age 9-15 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Male, Age 16-26 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 16, Female, Age 16-26 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Male, Age 9-15 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Female, Age 9-15 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Male, Age 16-26 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Quadrivalent Anti-HPV 18, Female, Age 16-26 Years
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Male, Age 9-15 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Female, Age 9-15 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Male, Age 16-26 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Nonavalent Anti-HPV 18, Female, Age 16-26 Years
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Injection site - Pain, any
|
90 participants
|
84 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Injection site - Swelling, any
|
15 participants
|
15 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Injection site - Erythema, any
|
15 participants
|
17 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Systemic - Headache
|
51 participants
|
33 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Systemic - Fever
|
17 participants
|
15 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Systemic - Nausea
|
29 participants
|
41 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Systemic - Dizziness
|
5 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Systemic - Fatigue
|
47 participants
|
24 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Prevention (Vaccine Therapy)- Quadrivalent
Serious events: 11 serious events
Other events: 129 other events
Deaths: 0 deaths
Prevention (Vaccine Therapy)- Nonavalent Vaccine
Serious events: 7 serious events
Other events: 108 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prevention (Vaccine Therapy)- Quadrivalent
n=253 participants at risk
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Prevention (Vaccine Therapy)- Nonavalent Vaccine
n=182 participants at risk
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.79%
2/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
0.55%
1/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse of primary cancer
|
1.2%
3/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
0.55%
1/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Subsequent malignant neoplasm
|
0.00%
0/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
0.55%
1/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
0.55%
1/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for musculoskeletal issue
|
1.6%
4/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
0.00%
0/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
Endocrine disorders
Hospitalization for endocrine disorder
|
0.79%
2/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
0.00%
0/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
Metabolism and nutrition disorders
Hospitalization for fluid-electrolyte disorder
|
0.00%
0/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
0.55%
1/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
Nervous system disorders
Hospitalization for neurologic disorder
|
0.00%
0/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
0.55%
1/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
Psychiatric disorders
Hospitalization for psychiatric disorder
|
0.00%
0/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
0.55%
1/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
Other adverse events
| Measure |
Prevention (Vaccine Therapy)- Quadrivalent
n=253 participants at risk
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
Prevention (Vaccine Therapy)- Nonavalent Vaccine
n=182 participants at risk
Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|
|---|---|---|
|
General disorders
Injection Site Pain or Tenderness, any
|
35.6%
90/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
46.2%
84/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
General disorders
Injection Site Swelling, any
|
5.9%
15/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
8.2%
15/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
General disorders
Injection Site Erythema, any
|
5.9%
15/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
9.3%
17/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
General disorders
Headache
|
20.2%
51/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
18.1%
33/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
General disorders
Fever (≥100.0⁰F)
|
6.7%
17/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
8.2%
15/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
Gastrointestinal disorders
Nausea
|
11.5%
29/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
22.5%
41/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
|
General disorders
Fatigue
|
18.6%
47/253 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
13.2%
24/182 • Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm. Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
|
Additional Information
Dr. Wendy Landier, Deputy Director, Institute for Cancer Outcomes and Survivorship
University of Alabama at Birmingham
Phone: (205) 638-2120
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place