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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092547
First received: September 23, 2004
Last updated: September 9, 2011
Last verified: September 2011
History of Changes
Results First Received: November 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Healthy Papillomavirus Infections
Interventions: Biological: V501
Biological: Comparator: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

1781 subjects were randomized to receive either 3 doses of qHPV or Placebo (Main Vaccination Phase).

At month 30, subjects who received Placebo during the Main Vaccination phase were eligible to receive 3 doses of qHPV, and formed the Extension Group. Subjects were to be followed for safety and efficacy up to Month 37, and from Month 42 to 126.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
qHPV Vaccine Represents subjects randomized to the V501 Quadrivalent Human Papillomavirus (qHPV) vaccine group
Placebo Represents subjects randomized to the placebo group
Extension Group Represent subjects originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV)given at Month 30, Month 32, and Month 36.

Participant Flow for 6 periods

 Period 1:   Vaccination Phase (Day 1 to Month 7)
    qHPV Vaccine     Placebo     Extension Group  
STARTED     1184     597     0  
Vaccinated     1179     596     0  
COMPLETED     1121     561     0  
NOT COMPLETED     63     36     0  
Not Vaccinated                 5                 1                 0  
Adverse Event                 4                 1                 0  
Lost to Follow-up                 18                 7                 0  
Withdrawal by Subject                 28                 21                 0  
Moved                 3                 1                 0  
per sponsor request: (noncompliant)                 0                 1                 0  
Did not meet local regulations                 0                 1                 0  
Refused Vaccination                 5                 3                 0  

Period 2:   Follow-up (After Month 7 to Month 18)
    qHPV Vaccine     Placebo     Extension Group  
STARTED     1128 [1]   565 [1]   0  
COMPLETED     1108     551     0  
NOT COMPLETED     20     14     0  
Lost to Follow-up                 13                 7                 0  
Physician Decision                 1                 0                 0  
Withdrawal by Subject                 4                 2                 0  
Subject Moved                 1                 5                 0  
Noncompliant                 1                 0                 0  
[1] Includes patients continuing in & patients who previously discontinued who re-entered the period

Period 3:   Extension (After Month 18 to Month 30)
    qHPV Vaccine     Placebo     Extension Group  
STARTED     964 [1]   490 [1]   0  
COMPLETED     956     485     0  
NOT COMPLETED     8     5     0  
Lost to Follow-up                 2                 0                 0  
Withdrawal by Subject                 1                 3                 0  
Subject Moved                 4                 2                 0  
Noncompliant                 1                 0                 0  
[1] Includes patients continuing in & patients who previously discontinued who re-entered the period

Period 4:   Extension (After Month 30 to Month 37)
    qHPV Vaccine     Placebo     Extension Group  
STARTED     956 [1]   0     485 [1]
COMPLETED     933     0     469  
NOT COMPLETED     23     0     16  
Lost to Follow-up                 14                 0                 7  
Withdrawal by Subject                 6                 0                 9  
Subject Moved                 3                 0                 0  
[1] Includes patients continuing in & patients who previously discontinued who re-entered the period

Period 5:   Extension (Month 42 Visit)
    qHPV Vaccine     Placebo     Extension Group  
STARTED     612 [1]   0     308 [1]
COMPLETED     612     0     308  
NOT COMPLETED     0     0     0  
[1] Includes patients continuing in & patients who previously discontinued who re-entered the period.

Period 6:   Extension (Month 72 Visit)
    qHPV Vaccine     Placebo     Extension Group  
STARTED     535 [1]   0     212 [1]
COMPLETED     535     0     212  
NOT COMPLETED     0     0     0  
[1] Includes patients continuing in & patients who previously discontinued who re-entered the period.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
qHPV Vaccine Represents subjects randomized to the Quadrivalent Human Papillomavirus (qHPV) vaccine group
Placebo Represents subjects randomized to the placebo group
Total Total of all reporting groups

Baseline Measures
    qHPV Vaccine     Placebo     Total  
Number of Participants  
[units: participants]
 		  1184     597     1781  
Age, Customized  
[units: Participants]
 		     
8 Years of Age and Under     0     0     0  
9 to 16 Years of Age     1184     597     1781  
17 Years of Age and Over     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  11.9  ± 1.9     11.8  ± 1.9     11.9  ± 1.9  
Gender  
[units: participants]
 		     
Female     616     322     938  
Male     568     275     843  
Race/Ethnicity, Customized  
[units: participants]
 		     
Asian     149     70     219  
Black     50     21     71  
Hispanic American     260     130     390  
Native American     0     1     1  
White     716     369     1085  
Other     9     6     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting Serious Adverse Experiences (SAE) in the Vaccination and Follow-up Phases   [ Time Frame: Day 1 through Month 18 ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants Reporting Serious Adverse Experiences (SAE) in the Extension Phases   [ Time Frame: Month 18 to Month 37 ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants Reporting Other (Non-serious) Adverse Experiences in the Vaccination and Follow-up Phases   [ Time Frame: Injection site AE are collected from Days 1-5 and non-serious AE from Days 1-15, including the day of vaccination. Other AE (Not Including Serious AE) were not collected in the Extension Phases ]
  Show Outcome Measure 3

4.  Primary:   Percentage of Participants Who Are Seropositive for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) 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) ]
  Show Outcome Measure 4

5.  Primary:   Percentage of Participants Who Are Seropositive for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) 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) ]
  Show Outcome Measure 5

6.  Primary:   Percentage of Participants Who Are Seropositive for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) 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) ]
  Show Outcome Measure 6

7.  Primary:   Percentage of Participants Who Are Seropositive for HPV Type 18 (HPV 18 ≥ 24 mMU/mL) 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) ]
  Show Outcome Measure 7

8.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 6 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) ]
  Show Outcome Measure 8

9.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 11 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) ]
  Show Outcome Measure 9

10.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 16 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) ]
  Show Outcome Measure 10

11.  Primary:   Geometric Mean Titers (GMTs) for Anti-HPV 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) ]
  Show Outcome Measure 11

12.  Secondary:   Number of Original Quadrivalent Human Papillomavirus (qHPV) Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 1 Postdose 3 (Month 7)   [ Time Frame: Month 7 (1 Month Postdose 3) ]
  Show Outcome Measure 12

13.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 1 Postdose 3 (Month 7)   [ Time Frame: Month 7 (1 Month Postdose 3) ]
  Show Outcome Measure 13

14.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 1 Postdose 3 (Month 7)   [ Time Frame: Month 7 (1 Month Postdose 3) ]
  Show Outcome Measure 14

15.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18 ≥ 24 mMU/mL) at Month 1 Postdose 3 (Month 7)   [ Time Frame: Month 7 (1 Month Postdose 3) ]
  Show Outcome Measure 15

16.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 12 Postdose 3 (Month 18).   [ Time Frame: Month 18 (12 Months Post-dose 3) ]
  Show Outcome Measure 16

17.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 12 Postdose 3 (Month 18)   [ Time Frame: Month 18 (12 Months Post-dose 3) ]
  Show Outcome Measure 17

18.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 12 Postdose 3 (Month 18)   [ Time Frame: Month 18 (12 Months Post-dose 3) ]
  Show Outcome Measure 18

19.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18 ≥ 24 mMU/mL) at Month 12 Postdose 3 (Month 18)   [ Time Frame: Month 18 (12 Months Post-dose 3) ]
  Show Outcome Measure 19

20.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 18 Postdose 3 (Month 24)   [ Time Frame: Month 24 (18 Months Post-dose 3) ]
  Show Outcome Measure 20

21.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 18 Postdose 3 (Month 24)   [ Time Frame: Month 24 (18 Months Post-dose 3) ]
  Show Outcome Measure 21

22.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 18 Postdose 3 (Month 24)   [ Time Frame: Month 24 (18 Months Post-dose 3) ]
  Show Outcome Measure 22

23.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) at Month 18 Postdose 3 (Month 24)   [ Time Frame: Month 24 (18 Months Post-dose 3) ]
  Show Outcome Measure 23

24.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 24 Postdose 3 (Month 30)   [ Time Frame: Month 30 (24 Months Post-dose 3) ]
  Show Outcome Measure 24

25.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 24 Postdose 3 (Month 30)   [ Time Frame: Month 30 (24 Months Post-dose 3) ]
  Show Outcome Measure 25

26.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 24 Postdose 3 (Month 30)   [ Time Frame: Month 30 (24 Months Post-dose 3) ]
  Show Outcome Measure 26

27.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) at Month 24 Postdose 3 (Month 30)   [ Time Frame: Month 30 (24 Months Post-dose 3) ]
  Show Outcome Measure 27

28.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 31 Postdose 3 (Month 37).   [ Time Frame: Month 37 (31 Months Post-dose 3) ]
  Show Outcome Measure 28

29.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 31 Postdose 3 (Month 37)   [ Time Frame: Month 37 (31 Months Post-dose 3) ]
  Show Outcome Measure 29

30.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 31 Postdose 3 (Month 37)   [ Time Frame: Month 37 (31 Months Post-dose 3) ]
  Show Outcome Measure 30

31.  Secondary:   Number of Original qHPV Vaccine Cohort Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) at Month 31 Postdose 3 (Month 37)   [ Time Frame: Month 37 (31 Months Post-dose 3) ]
  Show Outcome Measure 31

32.  Secondary:   Number of Subjects in the Extension Group Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) at Month 1 Postdose 3 of qHPV (Month 37)   [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ]
  Show Outcome Measure 32

33.  Secondary:   Number of Subjects in the Extension Group Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) at Month 1 Postdose 3 of qHPV (Month 37)   [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ]
  Show Outcome Measure 33

34.  Secondary:   Number of Subjects in the Extension Group Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) at Month 1 Postdose 3 of qHPV (Month 37)   [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ]
  Show Outcome Measure 34

35.  Secondary:   Number of Subjects in the Extension Group Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) at Month 1 Postdose 3 of qHPV (Month 37)   [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ]
  Show Outcome Measure 35

36.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)   [ Time Frame: Month 7 (1 Month Post-dose 3) ]
  Show Outcome Measure 36

37.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)   [ Time Frame: Month 7 (1 Month Post-dose 3) ]
  Show Outcome Measure 37

38.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)   [ Time Frame: Month 7 (1 Month Post-dose 3) ]
  Show Outcome Measure 38

39.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)   [ Time Frame: Month 7 (1 Month Post-dose 3) ]
  Show Outcome Measure 39

40.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)   [ Time Frame: Month 18 (Month 12 Post-dose 3) ]
  Show Outcome Measure 40

41.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)   [ Time Frame: Month 18 (12 Months Post-dose 3) ]
  Show Outcome Measure 41

42.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)   [ Time Frame: Month 18 (12 Months Post-dose 3) ]
  Show Outcome Measure 42

43.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18).   [ Time Frame: Month 18 (12 Months Post-dose 3) ]
  Show Outcome Measure 43

44.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)   [ Time Frame: Month 24 (18 Months Post-dose 3) ]
  Show Outcome Measure 44

45.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)   [ Time Frame: Month 24 (18 Months Post-dose 3) ]
  Show Outcome Measure 45

46.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)   [ Time Frame: Month 24 (18 Months Post-dose 3) ]
  Show Outcome Measure 46

47.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)   [ Time Frame: Month 24 (18 Months Post-dose 3) ]
  Show Outcome Measure 47

48.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)   [ Time Frame: Month 30 (24 Months Post-dose 3) ]
  Show Outcome Measure 48

49.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)   [ Time Frame: Month 30 (24 Months Post-dose 3) ]
  Show Outcome Measure 49

50.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)   [ Time Frame: Month 30 (24 Months Post-dose 3) ]
  Show Outcome Measure 50

51.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)   [ Time Frame: Month 30 (24 Months Post-dose 3) ]
  Show Outcome Measure 51

52.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 6 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)   [ Time Frame: Month 37 (31 Months Post-dose 3) ]
  Show Outcome Measure 52

53.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 11 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)   [ Time Frame: Month 37 (31 Months Post-dose 3) ]
  Show Outcome Measure 53

54.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 16 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)   [ Time Frame: Month 37 (31 Months Post-dose 3) ]
  Show Outcome Measure 54

55.  Secondary:   Geometric Mean Titers (GMTs) of Original qHPV Vaccine Cohort for Anti-HPV 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)   [ Time Frame: Month 37 (31 Months Post-dose 3) ]
  Show Outcome Measure 55

56.  Secondary:   Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 6 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)   [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ]
  Show Outcome Measure 56

57.  Secondary:   Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 11 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)   [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ]
  Hide Outcome Measure 57

Measure Type Secondary
Measure Title Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 11 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)
Measure Description No text entered.
Time Frame Month 37 (1 Month Post-dose 3 of qHPV)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects who received qHPV vaccine starting at Month 30 and who were seronegative from Day 1 through Month 30 (prior to receiving Dose 1 of qHPV vaccine).

Reporting Groups
  Description
Extension Group Represent subjects originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV)given at Month 30, Month 32, and Month 36.

Measured Values
    Extension Group  
Number of Participants Analyzed  
[units: participants]
 		  414  
Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 11 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)  
[units: milliMerck units/mL]
Geometric Mean ( 95% Confidence Interval ) 		  988.0  
  ( 900.4 to 1084.1 )  

No statistical analysis provided for Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 11 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)



58.  Secondary:   Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 16 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)   [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ]
  Show Outcome Measure 58

59.  Secondary:   Geometric Mean Titers (GMTs) of Subjects in the Extension Group for Anti-HPV 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)   [ Time Frame: Month 37 (1 Month Post-dose 3 of qHPV) ]
  Show Outcome Measure 59


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:

Publications automatically indexed to this study:


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00092547     History of Changes
Other Study ID Numbers: V501-018, 2004_084
Study First Received: September 23, 2004
Results First Received: November 3, 2009
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration