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

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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.

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

Period 2: Follow-up (After Month 7 to Month 18)

	qHPV Vaccine	Placebo
STARTED	1128 ^[1]	565 ^[1]
COMPLETED	1108	551
NOT COMPLETED	20	14
Lost to Follow-up	13	7
Physician Decision	1	0
Withdrawal by Subject	4	2
Subject Moved	1	5
Noncompliant	1	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
STARTED	964 ^[1]	490 ^[1]
COMPLETED	956	485
NOT COMPLETED	8	5
Lost to Follow-up	2	0
Withdrawal by Subject	1	3
Subject Moved	4	2
Noncompliant	1	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	Extension Group
STARTED	956 ^[1]	485 ^[1]
COMPLETED	933	469
NOT COMPLETED	23	16
Lost to Follow-up	14	7
Withdrawal by Subject	6	9
Subject Moved	3	0

[1]	Includes patients continuing in & patients who previously discontinued who re-entered the period

Period 5: Extension (Month 42 Visit)

	qHPV Vaccine	Extension Group
STARTED	612 ^[1]	308 ^[1]
COMPLETED	612	308
NOT COMPLETED	0	0

[1]	Includes patients continuing in & patients who previously discontinued who re-entered the period.

Period 6: Extension (Month 72 Visit)

	qHPV Vaccine	Extension Group
STARTED	535 ^[1]	212 ^[1]
COMPLETED	535	212
NOT COMPLETED	0	0

[1]	Includes patients continuing in & patients who previously discontinued who re-entered the period.

Baseline Characteristics

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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) ]

Show Outcome Measure 57

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

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Other Adverse Events

Show Other Adverse Events

More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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:

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.

Perez G, Lazcano-Ponce E, Hernandez-Avila M, García PJ, Muñoz 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.

Publications automatically indexed to this study:

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 EI; 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):1179-88.

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

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