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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05425732




Registration number
NCT05425732
Ethics application status
Date submitted
15/06/2022
Date registered
21/06/2022
Date last updated
10/06/2024

Titles & IDs
Public title
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
Scientific title
A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults
Secondary ID [1] 0 0
V116-003
Secondary ID [2] 0 0
V116-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - V116
Other interventions - PCV20

Experimental: Cohort 1 V116 - Pneumococcal vaccine-naïve adult participants (=50 years of age) receive a single dose of V116 on Day 1.

Active Comparator: Cohort 1 PCV20 - Pneumococcal vaccine-naïve adult participants (=50 years of age) receive a single dose of PCV20 on Day 1.

Experimental: Cohort 2 V116 - Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.

Active Comparator: Cohort 2 PCV20 - Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.


Other interventions: V116
0.5 mL injection solution in prefilled syringe containing 4 µg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.

Other interventions: PCV20
0.5 mL injection suspension in prefilled syringe containing 2.2 µg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 µg of PnPs antigen 6B.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Timepoint [1] 0 0
Up to 5 days post-vaccination
Primary outcome [2] 0 0
Percentage of Participants With Solicited Systemic AEs
Timepoint [2] 0 0
Up to 5 days post-vaccination
Primary outcome [3] 0 0
Percentage of Participants With Vaccine-related Serious AE (SAE)
Timepoint [3] 0 0
Up to 194 days post-vaccination
Primary outcome [4] 0 0
Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Timepoint [4] 0 0
Day 30 post-vaccination
Primary outcome [5] 0 0
Percentage of Participants With =4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
Timepoint [5] 0 0
Baseline and Day 30 post-vaccination
Primary outcome [6] 0 0
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
Timepoint [6] 0 0
Day 30 post-vaccination
Secondary outcome [1] 0 0
Percentage of Participants From Cohort 1 V116 With =4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes
Timepoint [1] 0 0
Baseline and Day 30 post-vaccination
Secondary outcome [2] 0 0
Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2
Timepoint [2] 0 0
Day 30 post-vaccination
Secondary outcome [3] 0 0
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
Timepoint [3] 0 0
Day 30 post-vaccination
Secondary outcome [4] 0 0
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Timepoint [4] 0 0
Baseline and Day 30 post-vaccination
Secondary outcome [5] 0 0
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Timepoint [5] 0 0
Baseline and Day 30 post-vaccination
Secondary outcome [6] 0 0
Percentage of Participants With =4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Timepoint [6] 0 0
Baseline and Day 30 post-vaccination
Secondary outcome [7] 0 0
Percentage of Participants With =4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
Timepoint [7] 0 0
Baseline and Day 30 post-vaccination

Eligibility
Key inclusion criteria
- For females, is not pregnant or breastfeeding and is either not a woman of
childbearing potential (WOCBP) or is a WOCBP and uses acceptable
contraception/abstinence; and has medical, menstrual, and recent sexual activity
history reviewed by the investigator to decrease the chance of an early undetected
pregnancy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive
cerebrospinal fluid culture, or positive culture at another sterile site] or known
history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day
1)

- Has a known hypersensitivity to any component of V116 or PCV20, including diphtheria
toxoid

- Has a known or suspected impairment of immunological function including, but not
limited to, a history of congenital or acquired immunodeficiency, documented human
immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of
autoimmune disease

- Has a coagulation disorder contraindicating IM vaccination

- Had a recent febrile illness (defined as oral or tympanic temperature =100.4°F
[=38.0°C] or axillary or temporal temperature =99.4°F [=37.4°C]) or received
antibiotic therapy for any acute illness occurring <72 hours before receipt of study
vaccine

- Has a known malignancy that is progressing or has required active treatment <3 years
before enrollment

- Received prior administration (prior to age of 5 is acceptable) of any pneumococcal
vaccine or is expected to receive any pneumococcal vaccine during the study outside
the protocol

- Received systemic corticosteroids (prednisone equivalent of =20 mg/day) for =14
consecutive days and has not completed intervention =14 days before receipt of study
vaccine

- Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or
other immunotherapies/immunomodulators used to treat cancer or other conditions, and
interventions associated with organ or bone marrow transplantation, or autoimmune
disease

- Received any nonlive vaccine =14 days before receipt of study vaccine or is scheduled
to receive any nonlive vaccine =30 days after receipt of study vaccine (inactivated
influenza and SARS-CoV2 vaccines may be acceptable)

- Received any live virus vaccine =30 days before receipt of study vaccine or is
scheduled to receive any live virus vaccine =30 days after receipt of study vaccine

- Received a blood transfusion or blood products, including immunoglobulin =6 months
before receipt of study vaccine or is scheduled to receive a blood transfusion or
blood product until the Day 30 postvaccination blood draw is complete

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/05/2023
Sample size
Target
Accrual to date
Final
2663
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra ( Site 3000) - Bruce
Recruitment hospital [2] 0 0
Emeritus Research ( Site 3004) - Botany
Recruitment hospital [3] 0 0
Paratus Clinical Research Central Coast ( Site 3001) - Kanwal
Recruitment hospital [4] 0 0
Westmead Hospital ( Site 3005) - Westmead
Recruitment hospital [5] 0 0
Emeritus Research ( Site 3003) - Camberwell
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Belgium
State/province [22] 0 0
Limburg
Country [23] 0 0
Belgium
State/province [23] 0 0
Namur
Country [24] 0 0
Chile
State/province [24] 0 0
Araucania
Country [25] 0 0
Chile
State/province [25] 0 0
Region M. De Santiago
Country [26] 0 0
Germany
State/province [26] 0 0
Hessen
Country [27] 0 0
Germany
State/province [27] 0 0
Nordrhein-Westfalen
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Incheon
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Kyonggi-do
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Taegu-Kwangyokshi
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
New Zealand
State/province [34] 0 0
Bay Of Plenty
Country [35] 0 0
New Zealand
State/province [35] 0 0
Canterbury
Country [36] 0 0
New Zealand
State/province [36] 0 0
Auckland
Country [37] 0 0
New Zealand
State/province [37] 0 0
Wellington
Country [38] 0 0
Puerto Rico
State/province [38] 0 0
Bayamon
Country [39] 0 0
Puerto Rico
State/province [39] 0 0
Caguas
Country [40] 0 0
Puerto Rico
State/province [40] 0 0
Canovanas
Country [41] 0 0
Puerto Rico
State/province [41] 0 0
Ponce
Country [42] 0 0
Puerto Rico
State/province [42] 0 0
San Juan
Country [43] 0 0
Sweden
State/province [43] 0 0
Skane Lan
Country [44] 0 0
Sweden
State/province [44] 0 0
Stockholms Lan
Country [45] 0 0
Sweden
State/province [45] 0 0
Uppsala Lan
Country [46] 0 0
Taiwan
State/province [46] 0 0
Tainan
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taipei
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taoyuan
Country [49] 0 0
Turkey
State/province [49] 0 0
Sakarya
Country [50] 0 0
Turkey
State/province [50] 0 0
Ankara
Country [51] 0 0
Turkey
State/province [51] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 3, randomized, double-blind, active comparator-controlled study of the
safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent
conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is
hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20
for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30
days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age
immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific
OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116.
Participants =50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years
of age will be enrolled in Cohort 2.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05425732
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries