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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/NCT05569954




Registration number
NCT05569954
Ethics application status
Date submitted
4/10/2022
Date registered
6/10/2022
Date last updated
22/11/2023

Titles & IDs
Public title
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)
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 50 Years of Age or Older
Secondary ID [1] 0 0
2022-001785-35
Secondary ID [2] 0 0
V116-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Disease 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 - PPSV23

Experimental: V116 Treatment - Participants receive a single intramuscular (IM) injection of V116 on Day 1.

Active Comparator: PPSV23 Treatment - Participants receive a single IM injection of PPSV23 on Day 1.


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

Other interventions: PPSV23
Sterile 0.5 mL solution in prefilled syringe containing 25 µg of each PnPs antigen 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.
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 AEs
Timepoint [1] 0 0
Up to 5 days postvaccination
Primary outcome [2] 0 0
Percentage of participants with solicited systemic AEs
Timepoint [2] 0 0
Up to 5 days postvaccination
Primary outcome [3] 0 0
Percentage of participants with vaccine-related serious AE (SAE)
Timepoint [3] 0 0
Up to 6 months postvaccination
Primary outcome [4] 0 0
Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs)
Timepoint [4] 0 0
Day 30 postvaccination
Primary outcome [5] 0 0
Percentage of participants with =4-fold rise from baseline in serotype-specific OPAs (unique to V116)
Timepoint [5] 0 0
Baseline (Day 1) and Day 30 postvaccination
Secondary outcome [1] 0 0
Percentage of participants with =4-fold rise from baseline in serotype-specific cross-reactive OPAs
Timepoint [1] 0 0
Baseline (Day 1) and Day 30 postvaccination
Secondary outcome [2] 0 0
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs)
Timepoint [2] 0 0
Day 30 postvaccination
Secondary outcome [3] 0 0
Serotype-specific geometric mean fold rise (GMFR) in OPA GMTs
Timepoint [3] 0 0
Baseline (Day 1) and Day 30 postvaccination
Secondary outcome [4] 0 0
Serotype-specific GMFR in IgG GMCs
Timepoint [4] 0 0
Baseline (Day 1) and Day 30 postvaccination
Secondary outcome [5] 0 0
Percentage of participants with =4-fold rise from baseline in serotype-specific OPA GMTs (all serotypes)
Timepoint [5] 0 0
Baseline (Day 1) and Day 30 postvaccination
Secondary outcome [6] 0 0
Percentage of participants with =4-fold rise from baseline in serotype-specific IgG GMCs
Timepoint [6] 0 0
Baseline (Day 1) and Day 30 postvaccination

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 inclusion of an early
undetected pregnancy
Minimum age
50 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 PPSV23, 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 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 assessing the outcomes
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/04/2025
Actual
Sample size
Target
Accrual to date
Final
1484
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Paratus Clinical Research Western Sydney ( Site 1500) - Blacktown
Recruitment hospital [2] 0 0
Northern Beaches Clinical Research ( Site 1502) - Brookvale
Recruitment hospital [3] 0 0
Paratus Clinical Research Brisbane ( Site 1501) - Albion
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2100 - Brookvale
Recruitment postcode(s) [3] 0 0
4010 - Albion
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Santa Fe
Country [2] 0 0
Colombia
State/province [2] 0 0
Atlantico
Country [3] 0 0
Colombia
State/province [3] 0 0
Valle Del Cauca
Country [4] 0 0
Germany
State/province [4] 0 0
Bayern
Country [5] 0 0
Germany
State/province [5] 0 0
Hessen
Country [6] 0 0
Germany
State/province [6] 0 0
Nordrhein-Westfalen
Country [7] 0 0
Germany
State/province [7] 0 0
Hamburg
Country [8] 0 0
Israel
State/province [8] 0 0
Haifa
Country [9] 0 0
Israel
State/province [9] 0 0
Jerusalem
Country [10] 0 0
Israel
State/province [10] 0 0
Kfar Saba
Country [11] 0 0
Israel
State/province [11] 0 0
Ramat Gan
Country [12] 0 0
Israel
State/province [12] 0 0
Sakhnin
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Kang-won-do
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Kwangju-Kwangyokshi
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Kyonggi-do
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Pusan-Kwangyokshi
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Taegu-Kwangyokshi
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Taejon-Kwangyokshi
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
New Zealand
State/province [20] 0 0
Manawatu-Wanganui
Country [21] 0 0
New Zealand
State/province [21] 0 0
Wellington
Country [22] 0 0
New Zealand
State/province [22] 0 0
Auckland
Country [23] 0 0
Spain
State/province [23] 0 0
Cataluna
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid, Comunidad De
Country [25] 0 0
Spain
State/province [25] 0 0
Valenciana, Comunitat
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Taiwan
State/province [28] 0 0
Kaohsiung
Country [29] 0 0
Taiwan
State/province [29] 0 0
Tainan
Country [30] 0 0
Taiwan
State/province [30] 0 0
Taipei
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taoyuan
Country [32] 0 0
Turkey
State/province [32] 0 0
Istanbul
Country [33] 0 0
Turkey
State/province [33] 0 0
Ankara
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Bradford
Country [35] 0 0
United Kingdom
State/province [35] 0 0
England
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Lancashire
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Northamptonshire
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Warwickshire

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 in pneumococcal vaccine-naïve adults 50
years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the
active comparator. In addition to studying safety/tolerability, it is hypothesized that, at
30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12
common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes
unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of
participants with =4-fold rise from baseline in unique V116 serotypes, as measured by
serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05569954
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05569954