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Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

Primary Purpose

Papillomavirus Infections

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
9vHPV vaccine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Papillomavirus Infections

Eligibility Criteria

9 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Boys and Girls 9 to 15 Years:

- Must not have had coitarche and does not plan on becoming sexually active during the vaccination period

Women 16 to 26 Years:

  • Has never had a Papanicolaou (Pap) test or only had normal Pap test results
  • A lifetime history of 0 to 4 male and/or female sexual partners

Cohort 0 Participants:

- Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine

Exclusion Criteria:

All Participants:

  • Known allergy to any vaccine component
  • History of severe allergic reaction that required medical intervention
  • Thrombocytopenia or any coagulation disorder
  • Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
  • Currently immunocompromised, or been diagnosed with immunodeficiency
  • Had a splenectomy
  • Receiving or has received immunosuppressive therapies within the last year
  • Received any immunoglobulin product or blood-derived product within 3 months
  • Has received more than 1 dose of an HPV vaccine (Cohort 0)
  • Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)

Sites / Locations

  • Kaiser Permanente Daly City ( Site 0044)
  • Kaiser Permanente Oakland ( Site 0020)
  • Kaiser Permanente Roseville ( Site 0047)
  • Kaiser Permanente Sacramento ( Site 0043)
  • Kaiser Permanente South Sacramento ( Site 0045)
  • Kaiser Permanente San Jose ( Site 0046)
  • Kaiser Permanente Santa Clara ( Site 0042)
  • Encompass Clinical Research ( Site 0022)
  • Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)
  • Tribe Clinical Research, LLC ( Site 0010)
  • Coastal Carolina Research Center ( Site 0032)
  • Coastal Bend Clinical Research ( Site 0025)
  • University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
  • MultiCare Rockwood Cheney Clinic ( Site 0038)
  • Fundación Centro de Investigación Clínica CIC ( Site 0157)
  • Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151)
  • CAIMED México ( Site 0207)
  • AINPAD ( Site 0204)
  • Unidad biomedica avanzada monterrey ( Site 0203)
  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
  • Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556)
  • Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555)
  • ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557)
  • Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553)
  • Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351)
  • TREAD Research ( Site 0354)
  • Desmond Tutu HIV Foundation ( Site 0355)
  • Taichung Veterans General Hospital ( Site 0653)
  • National Taiwan University Hospital ( Site 0651)
  • Chang Gung Medical Foundation.Linkou Branch ( Site 0652)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)

Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart

Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart

Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart

Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart

Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period

Arm Description

10 to 15 year old girls and boys (who previously received 1 dose of 9vHPV vaccine) receive a second dose of 9vHPV vaccine at Day 1.

9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12.

9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24.

9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36.

9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.

16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6.

Outcomes

Primary Outcome Measures

Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay
Serum antibody titers for human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using competitive luminex immunoassay (cLIA). The geometric mean titer (GMT) for each HPV type will be reported in milli Merck units/mL (mMU/mL).
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with injection-site AEs (erythema/redness, pain and swelling) will be assessed.
Percentage of Participants With at Least 1 Systemic Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with a systemic AE will be assessed.
Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event
A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is defined as a vaccine-related SAE.

Secondary Outcome Measures

Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.
Geometric Mean Titers (Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.
Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.
Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52 , and 58
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.

Full Information

First Posted
January 12, 2021
Last Updated
May 18, 2022
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04708041
Brief Title
Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)
Official Title
A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen With Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared With a Standard 3-dose Regimen in 16- to 26-Year Old Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
June 18, 2029 (Anticipated)
Study Completion Date
June 18, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)
Arm Type
Experimental
Arm Description
10 to 15 year old girls and boys (who previously received 1 dose of 9vHPV vaccine) receive a second dose of 9vHPV vaccine at Day 1.
Arm Title
Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart
Arm Type
Experimental
Arm Description
9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12.
Arm Title
Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart
Arm Type
Experimental
Arm Description
9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24.
Arm Title
Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart
Arm Type
Experimental
Arm Description
9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36.
Arm Title
Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart
Arm Type
Experimental
Arm Description
9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.
Arm Title
Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period
Arm Type
Active Comparator
Arm Description
16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6.
Intervention Type
Biological
Intervention Name(s)
9vHPV vaccine
Intervention Description
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Primary Outcome Measure Information:
Title
Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay
Description
Serum antibody titers for human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using competitive luminex immunoassay (cLIA). The geometric mean titer (GMT) for each HPV type will be reported in milli Merck units/mL (mMU/mL).
Time Frame
4 weeks post last vaccination (Up to ~Month 61)
Title
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with injection-site AEs (erythema/redness, pain and swelling) will be assessed.
Time Frame
Up to 5 days post vaccination
Title
Percentage of Participants With at Least 1 Systemic Adverse Event
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with a systemic AE will be assessed.
Time Frame
Up to 15 days post vaccination
Title
Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event
Description
A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is defined as a vaccine-related SAE.
Time Frame
Entire study period (Up to ~Month 96)
Secondary Outcome Measure Information:
Title
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Description
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.
Time Frame
4 weeks post last vaccination
Title
Geometric Mean Titers (Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Description
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.
Time Frame
12 months post last vaccination
Title
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Description
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.
Time Frame
12 months post last vaccination
Title
Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Description
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.
Time Frame
24 months post last vaccination
Title
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Description
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.
Time Frame
24 months post last vaccination
Title
Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52 , and 58
Description
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.
Time Frame
36 months post last vaccination
Title
Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Description
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.
Time Frame
36 months post last vaccination

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Healthy male and female participants between the ages of 9 to 15 years (inclusive) and female participants between the ages of 16 and 26 years (inclusive) will be enrolled in this study.
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Boys and Girls 9 to 15 Years: - Must not have had coitarche and does not plan on becoming sexually active during the vaccination period Women 16 to 26 Years: Has never had a Papanicolaou (Pap) test or only had normal Pap test results A lifetime history of 0 to 4 male and/or female sexual partners Cohort 0 Participants: - Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine Exclusion Criteria: All Participants: Known allergy to any vaccine component History of severe allergic reaction that required medical intervention Thrombocytopenia or any coagulation disorder Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7 Currently immunocompromised, or been diagnosed with immunodeficiency Had a splenectomy Receiving or has received immunosuppressive therapies within the last year Received any immunoglobulin product or blood-derived product within 3 months Has received more than 1 dose of an HPV vaccine (Cohort 0) Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Permanente Daly City ( Site 0044)
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
Kaiser Permanente Oakland ( Site 0020)
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente Roseville ( Site 0047)
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Kaiser Permanente Sacramento ( Site 0043)
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Kaiser Permanente South Sacramento ( Site 0045)
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente San Jose ( Site 0046)
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente Santa Clara ( Site 0042)
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Encompass Clinical Research ( Site 0022)
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Tribe Clinical Research, LLC ( Site 0010)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Coastal Carolina Research Center ( Site 0032)
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Coastal Bend Clinical Research ( Site 0025)
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78413
Country
United States
Facility Name
University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
MultiCare Rockwood Cheney Clinic ( Site 0038)
City
Cheney
State/Province
Washington
ZIP/Postal Code
99004
Country
United States
Facility Name
Fundación Centro de Investigación Clínica CIC ( Site 0157)
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050021
Country
Colombia
Facility Name
Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151)
City
Chia
State/Province
Cundinamarca
ZIP/Postal Code
250001
Country
Colombia
Facility Name
CAIMED México ( Site 0207)
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
AINPAD ( Site 0204)
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58350
Country
Mexico
Facility Name
Unidad biomedica avanzada monterrey ( Site 0203)
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-369
Country
Poland
Facility Name
Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
91-347
Country
Poland
Facility Name
ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557)
City
Tarnow
State/Province
Malopolskie
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553)
City
Debica
State/Province
Podkarpackie
ZIP/Postal Code
39-200
Country
Poland
Facility Name
Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1864
Country
South Africa
Facility Name
TREAD Research ( Site 0354)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Desmond Tutu HIV Foundation ( Site 0355)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7795
Country
South Africa
Facility Name
Taichung Veterans General Hospital ( Site 0653)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0651)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chang Gung Medical Foundation.Linkou Branch ( Site 0652)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
33857679
Citation
Teppler H, Bautista O; Thomas Group; Flores S, McCauley J, Luxembourg A. Design of a Phase III immunogenicity and safety study evaluating two-dose regimens of 9-valent human papillomavirus (9vHPV) vaccine with extended dosing intervals. Contemp Clin Trials. 2021 Jun;105:106403. doi: 10.1016/j.cct.2021.106403. Epub 2021 Apr 12.
Results Reference
result

Learn more about this trial

Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

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