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CompletedNCT00092547Updated Feb 20, 2018Results posted

A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

A Phase 3 interventional study of V501 and Comparator: Placebo in Human and Papillomavirus Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 9 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-20.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2003, registered Sep 2004).
Phase
Phase 3
Study type
Interventional
Enrollment
1,781
Allocation
Randomized
Ages
9 Years to 15 Years
Sex
All
01

Study summary

This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).

Read the detailed description

The original base protocol (V501-018)(NCT00092547) was extended in amendments V501-018-05 and -06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.

The study was extended again in amendment V501-018-10(NCT00092547), titled "A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age" to allow a follow-up period to Month 126.

02

Conditions studied

  • Human
  • Papillomavirus Infections
03

In context

Papillomavirus Infections

496 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.

This study's enrollment of 1,781 is above the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adolescents and preadolescents with no prior sexual history

Exclusion criteria

Exclusion Criteria:

  • Subjects with compromised immune system or have a history of severe allergic reaction
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,781 participants (actual)

Study arms

  • Experimental
    qHPV Vaccine in Base Study

    Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.

    Biological: V501

  • Placebo comparator
    Placebo in Base Study

    Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.

    Biological: Comparator: Placebo

  • Experimental
    qHPV Vaccine in Extension Study

    Represents participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.

    Biological: V501

Interventions

  • BiologicalV501

    0.5 mL intramuscular injection of V501

    Also known as: GARDASIL™

  • BiologicalComparator: Placebo

    0.5 mL intramuscular injection of placebo

06

What researchers measure

Primary outcomes

  1. Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18

    Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

    Time frame: Up to Month 18

  2. Number of Participants Reporting SAEs From Month 18 Through Month 37

    Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37

    Time frame: Month 18 to Month 37

  3. Number of Participants Reporting Other (Non-serious) AEs Through Month 18

    Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18

    Time frame: Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination

  4. Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72

    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

    Time frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)

  5. Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72

    Time frame: Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)

  6. Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96

    Time frame: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)

  7. Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96

    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

    Time frame: Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)

  8. Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126

    Time frame: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)

  9. Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126

    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

    Time frame: Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)

  10. Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up

    A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported.

    Time frame: Month 37 to Month 126

Secondary outcomes

  1. Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)

    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

    Time frame: Month 7 (1 Month Postdose 3)

  2. Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).

    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

    Time frame: Month 18 (12 Months Post-dose 3)

  3. Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)

    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

    Time frame: Month 24 (18 Months Post-dose 3)

  4. Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)

    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

    Time frame: Month 30 (24 Months Post-dose 3)

  5. Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).

    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

    Time frame: Month 37 (31 Months Post-dose 3)

  6. Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)

    A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

    Time frame: Month 37 (1 Month Post-dose 3 of qHPV)

  7. Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)

    Time frame: Month 7 (1 Month Post-dose 3)

  8. Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)

    Time frame: Month 18 (Month 12 Post-dose 3)

  9. Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)

    Time frame: Month 24 (18 Months Post-dose 3)

  10. Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)

    Time frame: Month 30 (24 Months Post-dose 3)

  11. Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)

    Time frame: Month 37 (31 Months Post-dose 3)

  12. Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)

    Time frame: Month 37 (1 Month Post-dose 3 of qHPV)

  13. Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females

    The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.

    Time frame: Up to Month 126

  14. Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males

    The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.

    Time frame: Up to Month 126

07

Results

Posted May 4, 2010
Limitations and caveats
The difference between the prior and final data is a minor change in the definition of the per-protocol immunogenicity population, which was applied down to the base study. Also, protocol violators were identified and excluded from the analysis.

Participant flow

1781 participants were randomized to receive qHPV or Placebo in the Base Study. At month 30, participants who received Placebo in the Base Study were eligible to receive qHPV, and formed the Extension Group. Participants were to be followed for safety and efficacy for up to 10 years.

Base Vaccine Phase (Day 1 to Month 7)
Participant flow — Base Vaccine Phase (Day 1 to Month 7)
MilestoneqHPV Vaccine in Base StudyPlacebo in Base StudyqHPV Vaccine in Extension Study
Started11845970
Vaccinated11795960
Completed11215610
Not completed63360
Withdrew: Not vaccinated510
Withdrew: Adverse event410
Withdrew: Lost to follow-up1870
Withdrew: Withdrawal by subject28210
Withdrew: Moved310
Withdrew: Per sponsor request: (noncompliant)010
Withdrew: Did not meet local regulations010
Withdrew: Refused vaccination530
Base Follow-up Phase (Month 7 to 18)
Participant flow — Base Follow-up Phase (Month 7 to 18)
MilestoneqHPV Vaccine in Base StudyPlacebo in Base StudyqHPV Vaccine in Extension Study
Started11285650
Completed11085510
Not completed20140
Withdrew: Subject moved150
Withdrew: Withdrawal by subject420
Withdrew: Lost to follow-up1370
Withdrew: Protocol violation100
Withdrew: Physician decision100
Base Follow-up Phase (Month 18 to 30)
Participant flow — Base Follow-up Phase (Month 18 to 30)
MilestoneqHPV Vaccine in Base StudyPlacebo in Base StudyqHPV Vaccine in Extension Study
Started9644900
Completed9564850
Not completed850
Withdrew: Subject moved420
Withdrew: Withdrawal by subject130
Withdrew: Lost to follow-up200
Withdrew: Protocol violation100
Extension Vaccine Phase (Month 30 to 37)
Participant flow — Extension Vaccine Phase (Month 30 to 37)
MilestoneqHPV Vaccine in Base StudyPlacebo in Base StudyqHPV Vaccine in Extension Study
Started9560485
Vaccinated in extension study00482
Completed9330469
Not completed23016
Withdrew: Subject moved300
Withdrew: Withdrawal by subject609
Withdrew: Lost to follow-up1407
Long-term Follow-up (Month 42 Visit)
Participant flow — Long-term Follow-up (Month 42 Visit)
MilestoneqHPV Vaccine in Base StudyPlacebo in Base StudyqHPV Vaccine in Extension Study
Started6120308
Completed6110308
Not completed100
Withdrew: Adverse event100
Long-term Follow-up (Month 72 Visit)
Participant flow — Long-term Follow-up (Month 72 Visit)
MilestoneqHPV Vaccine in Base StudyPlacebo in Base StudyqHPV Vaccine in Extension Study
Started5500276
Completed5500276
Not completed000
Long-term Follow-up (Month 96 Visit)
Participant flow — Long-term Follow-up (Month 96 Visit)
MilestoneqHPV Vaccine in Base StudyPlacebo in Base StudyqHPV Vaccine in Extension Study
Started5080267
Completed5080267
Not completed000
Long-term Follow-up (Month 126 Visit)
Participant flow — Long-term Follow-up (Month 126 Visit)
MilestoneqHPV Vaccine in Base StudyPlacebo in Base StudyqHPV Vaccine in Extension Study
Started4540211
Completed4540211
Not completed000

Outcome measures

PrimaryNumber of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18

Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

Time frame:
Up to Month 18
Reported as:
Number · participants
Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18
participantsqHPV Vaccine in Base StudyPlacebo in Base Study
Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 1860
PrimaryNumber of Participants Reporting SAEs From Month 18 Through Month 37

Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37

Time frame:
Month 18 to Month 37
Reported as:
Number · participants
Number of Participants Reporting SAEs From Month 18 Through Month 37
participantsqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Number of Participants Reporting SAEs From Month 18 Through Month 3703
PrimaryNumber of Participants Reporting Other (Non-serious) AEs Through Month 18

Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18

Time frame:
Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination
Reported as:
Number · participants
Number of Participants Reporting Other (Non-serious) AEs Through Month 18
participantsqHPV Vaccine in Base StudyPlacebo in Base Study
Number of Participants Reporting Other (Non-serious) AEs Through Month 18918340
PrimaryPercentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Time frame:
Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
Reported as:
Number · Percentage of participants
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72
Percentage of participantsqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Type 6: n=475, 15193.3 (90.6 to 95.3)91.4 (85.7 to 95.3)
Type 11: n=475, 15196.0 (93.8 to 97.6)96.7 (92.4 to 98.9)
Type 16: n=473, 15497.9 (96.1 to 99.0)97.4 (93.5 to 99.3)
Type 18: n=477, 16074.4 (70.3 to 78.3)79.4 (72.3 to 85.4)
PrimaryGeometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72
Time frame:
Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)
Reported as:
Geometric mean · milliMerck units/mL
Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72
milliMerck units/mLqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Type 6: n=475, 151118.9 (108.4 to 130.4)113.9 (95.7 to 135.6)
Type 11: n=475, 151135.7 (122.6 to 150.3)137.9 (114.9 to 165.5)
Type 16: n=473, 154521.2 (466.2 to 582.6)485.8 (396.4 to 595.3)
Type 18: n=477, 16070.9 (61.8 to 81.4)67.7 (53.1 to 86.3)
PrimaryGeometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96
Time frame:
Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)
Reported as:
Geometric mean · milliMerck units/mL
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96
milliMerck units/mLqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Type 6: n=451, 14171.4 (64.6 to 79.0)91.0 (76.4 to 108.6)
Type 11: n=451, 14167.5 (60.1 to 75.7)90.3 (74.0 to 110.1)
Type 16: n=447, 143325.5 (288.6 to 367.1)387.4 (314.7 to 476.9)
Type 18: n=452, 15241.6 (36.5 to 47.5)48.3 (37.6 to 62.0)
PrimaryPercentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Time frame:
Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)
Reported as:
Number · Percentage of participants
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96
Percentage of participantsqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Type 6: n=451, 14188.2 (84.9 to 91.1)91.5 (85.6 to 95.5)
Type 11: n=451, 14189.1 (85.9 to 91.9)93.6 (88.2 to 97.0)
Type 16: n=447, 14396.9 (94.8 to 98.3)97.9 (94.0 to 99.6)
Type 18: n=452, 15263.9 (59.3 to 68.4)69.1 (61.1 to 76.3)
PrimaryGeometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126
Time frame:
Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
Reported as:
Geometric mean · milliMerck units/mL
Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126
milliMerck units/mLqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Type 6: n=409, 11288.0 (78.9 to 98.2)99.3 (81.0 to 121.6)
Type 11: n=409, 11274.6 (66.1 to 84.1)96.0 (76.1 to 121.1)
Type 16: n=403, 115320.1 (281.2 to 364.4)351.6 (277.1 to 446.2)
Type 18: n=408, 12036.5 (31.7 to 42.1)39.6 (30.7 to 51.2)
PrimaryPercentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Time frame:
Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)
Reported as:
Number · Percentage of participants
Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126
Percentage of participantsqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Type 6: n=409, 11289.0 (85.6 to 91.9)91.1 (84.2 to 95.6)
Type 11: n=409, 11288.8 (85.3 to 91.6)92.9 (86.4 to 96.9)
Type 16: n=403, 11596.0 (93.6 to 97.7)96.5 (91.3 to 99.0)
Type 18: n=408, 12060.5 (55.6 to 65.3)65.0 (55.8 to 73.5)
PrimaryNumber of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up

A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported.

Time frame:
Month 37 to Month 126
Reported as:
Number · Participants
Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up
ParticipantsqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up01
SecondaryPercentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Time frame:
Month 7 (1 Month Postdose 3)
Reported as:
Number · Percentage of participants
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)
Percentage of participantsqHPV Vaccine in Base Study
Type 6: n=95399.8 (99.2 to 100)
Type 11: n=95499.8 (99.2 to 100)
Type 16: n=94999.7 (99.1 to 99.9)
Type 18: n=95699.7 (99.1 to 99.9)
SecondaryPercentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Time frame:
Month 18 (12 Months Post-dose 3)
Reported as:
Number · Percentage of participants
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).
Percentage of participantsqHPV Vaccine in Base Study
Type 6: n=93797.8 (96.6 to 98.6)
Type 11: n=93899.3 (98.5 to 99.7)
Type 16: n=93399.6 (98.9 to 99.9)
Type 18: n=94091.6 (89.6 to 93.3)
SecondaryPercentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Time frame:
Month 24 (18 Months Post-dose 3)
Reported as:
Number · Percentage of participants
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)
Percentage of participantsqHPV Vaccine in Base Study
Type 6: n=44695.1 (92.6 to 96.9)
Type 11: n=44798.2 (96.5 to 99.2)
Type 16: n=44298.4 (96.8 to 99.4)
Type 18: n=44787.5 (84.0 to 90.4)
SecondaryPercentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Time frame:
Month 30 (24 Months Post-dose 3)
Reported as:
Number · Percentage of participants
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)
Percentage of participantsqHPV Vaccine in Base Study
Type 6: n=79995.6 (94.0 to 96.9)
Type 11: n=80097.5 (96.2 to 98.5)
Type 16: n=79598.6 (97.5 to 99.3)
Type 18: n=80384.3 (81.6 to 86.8)
SecondaryPercentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Time frame:
Month 37 (31 Months Post-dose 3)
Reported as:
Number · Percentage of participants
Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).
Percentage of participantsqHPV Vaccine in Base Study
Type 6: n=65794.5 (92.5 to 96.1)
Type 11: n=65796.0 (94.3 to 97.4)
Type 16: n=65598.2 (96.8 to 99.0)
Type 18: n=66081.1 (77.9 to 84.0)
SecondaryPercentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)

A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.

Time frame:
Month 37 (1 Month Post-dose 3 of qHPV)
Reported as:
Number · Percentage of participants
Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)
Percentage of participantsqHPV Vaccine in Extension Study
Type 6: n=24699.6 (97.8 to 100)
Type 11: n=246100 (98.5 to 100)
Type 16: n=246100 (98.5 to 100)
Type 18: n=25598.8 (96.6 to 99.8)
SecondaryGeometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)
Time frame:
Month 7 (1 Month Post-dose 3)
Reported as:
Geometric mean · milliMerck units/mL
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)
milliMerck units/mLqHPV Vaccine in Base Study
Type 6: n=953929.2 (871.0 to 991.4)
Type 11: n=9541362.8 (1279.8 to 1451.3)
Type 16: n=9495512.7 (5109.9 to 5947.2)
Type 18: n=9561278.9 (1183.2 to 1382.4)
SecondaryGeometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)
Time frame:
Month 18 (Month 12 Post-dose 3)
Reported as:
Geometric mean · milliMerck units/mL
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)
milliMerck units/mLqHPV Vaccine in Base Study
Type 6: n=937219.3 (204.9 to 234.7)
Type 11: n=938296.9 (276.9 to 318.3)
Type 16: n=9331314.8 (1220.5 to 1416.5)
Type 18: n=940203.0 (184.1 to 223.9)
SecondaryGeometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)
Time frame:
Month 24 (18 Months Post-dose 3)
Reported as:
Geometric mean · milliMerck units/mL
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)
milliMerck units/mLqHPV Vaccine in Base Study
Type 6: n=446143.5 (129.2 to 159.5)
Type 11: n=447206.6 (186.9 to 228.3)
Type 16: n=442932.1 (833.3 to 1042.7)
Type 18: n=447136.2 (118.5 to 156.6)
SecondaryGeometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)
Time frame:
Month 30 (24 Months Post-dose 3)
Reported as:
Geometric mean · milliMerck units/mL
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)
milliMerck units/mLqHPV Vaccine in Base Study
Type 6: n=799146.5 (135.6 to 158.2)
Type 11: n=800177.0 (163.6 to 191.5)
Type 16: n=795826.1 (757.8 to 900.5)
Type 18: n=803114.7 (102.8 to 127.9)
SecondaryGeometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)
Time frame:
Month 37 (31 Months Post-dose 3)
Reported as:
Geometric mean · milliMerck units/mL
Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)
milliMerck units/mLqHPV Vaccine in Base Study
Type 6: n=657128.6 (118.2 to 139.9)
Type 11: n=657149.7 (137.0 to 163.6)
Type 16: n=655680.4 (617.2 to 750.1)
Type 18: n=660102.4 (90.9 to 115.3)
SecondaryGeometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)
Time frame:
Month 37 (1 Month Post-dose 3 of qHPV)
Reported as:
Geometric mean · milliMerck units/mL
Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)
milliMerck units/mLqHPV Vaccine in Extension Study
Type 6: n=246768.6 (676.6 to 873.0)
Type 11: n=2461041.0 (919.8 to 1178.2)
Type 16: n=2464312.7 (3715.6 to 5005.7)
Type 18: n=255830.1 (714.0 to 965.1)
SecondaryCombined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females

The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.

Time frame:
Up to Month 126
Reported as:
Number · Cases per 100 person-years at risk
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females
Cases per 100 person-years at riskqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females0.2 (0.1 to 0.7)0.2 (0.0 to 1.4)
SecondaryCombined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males

The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.

Time frame:
Up to Month 126
Reported as:
Number · Cases per 100 person-years at risk
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males
Cases per 100 person-years at riskqHPV Vaccine in Base StudyqHPV Vaccine in Extension Study
Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males0.6 (0.2 to 1.5)0.3 (0.0 to 1.9)

Adverse events

Collected over Day 1 to Month 30 and Month 30 to Month 126. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
qHPV Vaccine in Base: Vaccine Phase and Follow-up—6/1,165 (0.5%)918/1,165 (78.8%)
Placebo in Base: Vaccine Phase and Follow-up—0/584 (0%)344/584 (58.9%)
qHPV Vaccine in Base: Extension and Long-term Follow-up—2/932 (0.2%)0/932 (0%)
qHPV Vaccine in Extension: Extension and Long-term Follow-up—3/481 (0.6%)3/481 (0.6%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventqHPV Vaccine in Base: Vaccine Phase and Follow-upPlacebo in Base: Vaccine Phase and Follow-upqHPV Vaccine in Base: Extension and Long-term Follow-upqHPV Vaccine in Extension: Extension and Long-term Follow-up
VIIth nerve paralysisNervous system disorders0/11650/5840/9321/481
Chest painGeneral disorders0/11650/5840/9321/481
Meniscus injuryInjury, poisoning and procedural complications0/11650/5840/9321/481
Road traffic accidentInjury, poisoning and procedural complications0/11650/5841/9320/481
Tonic clonic movementsNervous system disorders0/11650/5841/9320/481
Acute kidney injuryRenal and urinary disorders1/11650/5840/9320/481
AppendicitisInfections and infestations1/11650/5840/9320/481
Colitis ulcerativeGastrointestinal disorders1/11650/5840/9320/481
Localised infectionInfections and infestations1/11650/5840/9320/481
Pain in extremityMusculoskeletal and connective tissue disorders1/11650/5840/9320/481
Most frequent other events
Most frequent other events
EventqHPV Vaccine in Base: Vaccine Phase and Follow-upPlacebo in Base: Vaccine Phase and Follow-upqHPV Vaccine in Base: Extension and Long-term Follow-upqHPV Vaccine in Extension: Extension and Long-term Follow-up
Injection site painGeneral disorders853/1165268/5840/9323/481
Injection site swellingGeneral disorders241/116545/5840/9321/481
Injection site erythemaGeneral disorders237/116578/5840/9321/481
HeadacheNervous system disorders221/1165111/5840/9320/481
PyrexiaGeneral disorders100/116544/5840/9320/481
Oropharyngeal painRespiratory, thoracic and mediastinal disorders52/116524/5840/9320/481

Baseline characteristics

Age, Continuous
Age, Continuous(years)qHPV Vaccine in Base StudyPlacebo in Base StudyTotal
Mean11.9 ± 1.911.8 ± 1.911.9 ± 1.9
Age, Customized
Age, Customized(Participants)qHPV Vaccine in Base StudyPlacebo in Base StudyTotal
8 Years of Age and Under000
9 to 16 Years of Age11845971781
17 Years of Age and Over000
Sex: Female, Male
Sex: Female, Male(Participants)qHPV Vaccine in Base StudyPlacebo in Base StudyTotal
Female616322938
Male568275843
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)qHPV Vaccine in Base StudyPlacebo in Base StudyTotal
Asian14970219
Black502171
Hispanic American260130390
Native American011
White7163691085
Other9615
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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, Puchalski D, Giacoletti KE, Sings HL, Lukac S, Alvarez FB, Barr E. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201-9. doi: 10.1097/01.inf.0000253970.29190.5a. PubMed 17484215 ↗
  • Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260. PubMed 18000825 ↗
  • Ferris D, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Reisinger KS, Mehlsen J, Chatterjee A, Iversen OE, Sings HL, Shou Q, Sausser TA, Saah A. Long-term study of a quadrivalent human papillomavirus vaccine. Pediatrics. 2014 Sep;134(3):e657-65. doi: 10.1542/peds.2013-4144. Epub 2014 Aug 18. PubMed 25136050 ↗
  • Ferris DG, Samakoses R, Block SL, Lazcano-Ponce E, Restrepo JA, Mehlsen J, Chatterjee A, Iversen OE, Joshi A, Chu JL, Krick AL, Saah A, Das R. 4-Valent Human Papillomavirus (4vHPV) Vaccine in Preadolescents and Adolescents After 10 Years. Pediatrics. 2017 Dec;140(6):e20163947. doi: 10.1542/peds.2016-3947. PubMed 29167376 ↗
  • Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21. PubMed 19935017 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00092547
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Sep 28, 2004
Start date
Oct 8, 2003
Primary completion
Nov 3, 2005
Completion
Jun 1, 2015
Results posted
May 4, 2010
Last update
Feb 20, 2018

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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