Trial Outcomes & Findings for Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants (NCT NCT02568566)
NCT ID: NCT02568566
Last Updated: 2025-07-14
Results Overview
Difference in the log-transformed HPV 16/18 antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
201 participants
Primary outcome timeframe
Between 6 and 24 months after prime dose and prior to the administration of the second dose
Results posted on
2025-07-14
Participant Flow
Participant milestones
| Measure |
Prevention (Gardasil 9)
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).
Laboratory Biomarker Analysis: Correlative studies
Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
|
|---|---|
|
Overall Study
STARTED
|
201
|
|
Overall Study
COMPLETED
|
187
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants
Baseline characteristics by cohort
| Measure |
Prevention (Gardasil 9)
n=201 Participants
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).
Laboratory Biomarker Analysis: Correlative studies
Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
|
|---|---|
|
Age, Continuous
|
10 years
STANDARD_DEVIATION 0.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
201 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between 6 and 24 months after prime dose and prior to the administration of the second dosePopulation: Analysis on participants who provided blood samples in all study visits
Difference in the log-transformed HPV 16/18 antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.
Outcome measures
| Measure |
Prevention (Gardasil 9)
n=179 Participants
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).
Laboratory Biomarker Analysis: Correlative studies
Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
|
|---|---|
|
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Difference in HPV16 titers between 6 and 12 months
|
-0.55 Log10 IU/ml
Standard Deviation 0.54
|
|
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Difference in HPV16 titers between 12 and 18 months
|
0.03 Log10 IU/ml
Standard Deviation 0.62
|
|
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Difference in HPV16 titers between 18 and 24 months
|
-0.002 Log10 IU/ml
Standard Deviation 0.64
|
|
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Difference in HPV18 titers between 6 and 12 months
|
-0.38 Log10 IU/ml
Standard Deviation 0.46
|
|
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Difference in HPV18 titers between 12 and 18 months
|
-0.005 Log10 IU/ml
Standard Deviation 0.53
|
|
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer
Difference in HPV18 titers between 18 and 24 months
|
-0.02 Log10 IU/ml
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Data are not available. The study team is working on analyzing the antibody titers of other HPV types.Difference in the log-transformed HPV type-specific antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 weeks post-treatmentOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 monthsOutcome measures
Outcome data not reported
Adverse Events
Prevention (Gardasil 9)
Serious events: 2 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prevention (Gardasil 9)
n=201 participants at risk
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).
Laboratory Biomarker Analysis: Correlative studies
Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
|
|---|---|
|
Infections and infestations
Appendicitis
|
0.50%
1/201 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.50%
1/201 • 30 months
|
Other adverse events
| Measure |
Prevention (Gardasil 9)
n=201 participants at risk
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).
Laboratory Biomarker Analysis: Correlative studies
Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
6.5%
13/201 • 30 months
|
|
Gastrointestinal disorders
Stomach pain
|
8.0%
16/201 • 30 months
|
|
General disorders
Fever
|
5.5%
11/201 • 30 months
|
|
General disorders
Flu like symptoms
|
7.5%
15/201 • 30 months
|
|
General disorders
Injection site reaction
|
34.3%
69/201 • 30 months
|
|
General disorders
Pain
|
5.5%
11/201 • 30 months
|
|
Infections and infestations
Upper respiratory infection
|
14.4%
29/201 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.5%
11/201 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
14/201 • 30 months
|
|
Nervous system disorders
Headache
|
16.9%
34/201 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.0%
14/201 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.5%
11/201 • 30 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60