A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)

Pneumonia, Pneumococcal Clinical Trial

Official title:

A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05526716
• Other study ID #: V116-005
• Status: Completed
• Phase: Phase 3
• Start date: September 23, 2022
• Est. completion date: June 21, 2023

Study information

• Verified date: June 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1080
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent

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
• Has a known hypersensitivity to any component of V116 or any influenza vaccine, 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 intramuscular vaccination
• Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
• Is expected to receive any pneumococcal vaccine during the study outside of the protocol
• Received any pneumococcal vaccine <12 months prior to enrollment (including pneumococcal 13-valent conjugate vaccine [PCV13] followed by pneumococcal 23-valent polysaccharide vaccine [PPSV23] and PPSV23 followed by PCV13)
• Had prior administration of PCV15 or PCV20
• Received any influenza vaccine <6 months prior to enrollment or is expected to receive any influenza vaccine during the study outside of 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
• 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 before the Day 30 postvaccination blood draw is complete
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study

Related Conditions & MeSH terms

• Pneumonia, Pneumococcal

Intervention

Biological:
• V116
Pneumococcal 21-valent conjugate vaccine with 4 µg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
• QIV
Single 0.5 mL IM injection
• Matching Placebo for V116
Single 0.5 mL of sterile saline IM injection

Locations

Country	Name	City	State
United States	Velocity Clinical Research, Anderson ( Site 0077)	Anderson	South Carolina
United States	Optimal Research ( Site 0015)	Austin	Texas
United States	Holston Medical Group-Clinical Research ( Site 0028)	Bristol	Tennessee
United States	Headlands Research - Brownsville ( Site 0069)	Brownsville	Texas
United States	Hope Clinical Research, Inc. ( Site 0070)	Canoga Park	California
United States	East Coast Institute for Research - Canton ( Site 0004)	Canton	Georgia
United States	Synexus Clinical Research US, Inc. ( Site 0072)	Chicago	Illinois
United States	CTI Clinical Research Center ( Site 0071)	Cincinnati	Ohio
United States	Velocity Clinical Research, Columbia ( Site 0058)	Columbia	South Carolina
United States	Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019)	Cortland	New York
United States	Velocity Clinical Research, Providence ( Site 0021)	East Greenwich	Rhode Island
United States	Centennial Medical Group ( Site 0035)	Elkridge	Maryland
United States	Carolina Institute for Clinical Research ( Site 0047)	Fayetteville	North Carolina
United States	Healthcare Research Network - Chicago ( Site 0014)	Flossmoor	Illinois
United States	Benchmark Research ( Site 0025)	Fort Worth	Texas
United States	Velocity Clinical Research, Hallandale Beach ( Site 0064)	Hallandale Beach	Florida
United States	Hatboro Medical Associates / CCT Research ( Site 0065)	Hatboro	Pennsylvania
United States	Indago Research & Health Center, Inc ( Site 0029)	Hialeah	Florida
United States	Innovative Medical Research of Texas ( Site 0079)	Houston	Texas
United States	New Horizon Medical Group ( Site 0078)	Houston	Texas
United States	East Coast Institute for Research, LLC ( Site 0013)	Jacksonville	Florida
United States	Health Awareness ( Site 0034)	Jupiter	Florida
United States	Holston Medical Group-Clinical Research ( Site 0009)	Kingsport	Tennessee
United States	Paradigm Clinical Research Centers, Inc ( Site 0024)	La Mesa	California
United States	WR-CRCN, LLC ( Site 0018)	Las Vegas	Nevada
United States	Alivation Research-Primary Care ( Site 0066)	Lincoln	Nebraska
United States	Velocity Clinical Research, Medford ( Site 0060)	Medford	Oregon
United States	Optimal Research ( Site 0008)	Melbourne	Florida
United States	Alpha Science Research ( Site 0042)	Miami	Florida
United States	Suncoast Research Associates ( Site 0041)	Miami	Florida
United States	Suncoast Research Group-Clinical Department ( Site 0062)	Miami	Florida
United States	Lakes Research ( Site 0063)	Miami Lakes	Florida
United States	Catalina Research Institute, LLC ( Site 0067)	Montclair	California
United States	Synexus Clinical Research US, Inc. ( Site 0001)	Murray	Utah
United States	Clinical Research Associates Inc ( Site 0026)	Nashville	Tennessee
United States	Synexus Clinical Research US, Inc - New York ( Site 0053)	New York	New York
United States	WR- PRI, LLC ( Site 0044)	Newport Beach	California
United States	Carbon Health - North Hollywood - NoHo West ( Site 0016)	North Hollywood	California
United States	Valley Clinical Trials, Inc. ( Site 0002)	Northridge	California
United States	LinQ Research ( Site 0074)	Pearland	Texas
United States	Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012)	Phoenix	Arizona
United States	M3 Wake Research Associates ( Site 0040)	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc. ( Site 0055)	Rochester	New York
United States	Healthcare Research Network - St. Louis ( Site 0011)	Saint Louis	Missouri
United States	Radiant Research ( Site 0073)	Saint Louis	Missouri
United States	Artemis Institute for Clinical Research ( Site 0023)	San Diego	California
United States	California Research Foundation ( Site 0005)	San Diego	California
United States	WR-MCCR, LLC ( Site 0033)	San Diego	California
United States	Axces Research ( Site 0037)	Santa Fe	New Mexico
United States	Alliance for Multispecialty Research, LLC ( Site 0051)	South Jordan	Utah
United States	Arthritis Northwest, PLLC ( Site 0059)	Spokane	Washington
United States	Velocity Clinical Research, Spokane ( Site 0050)	Spokane	Washington
United States	Clinical Research Atlanta ( Site 0068)	Stockbridge	Georgia
United States	Meridian Clinical Research, LLC ( Site 0032)	Vestal	New York
United States	Diablo Clinical Research, Inc. ( Site 0020)	Walnut Creek	California
United States	Triple O Research Institute, P.A ( Site 0054)	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Solicited Injection-site Adverse Events (AEs)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs include tenderness/injection-site pain, injection-site redness/injection-site erythema, and injection-site swelling/injection-site swelling.	Up to 5 days post-vaccination
Primary	Percentage of Participants with Solicited Systemic AEs	An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The solicited systemic AEs include muscle aches all over body/myalgia, headache, and tiredness/fatigue.	Up to 5 days post-vaccination
Primary	Percentage of Participants with Vaccine-related Serious Adverse Events (SAEs)	A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination will be summarized.	Up to ~210 days
Primary	Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses	Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA).	30 days after V116 vaccination (Day 30 for concomitant group and Day 60 for sequential group)
Primary	GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)	Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay	Day 30
Secondary	Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)	The GMC of serotype-specific IgG for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an pneumococcal electrochemiluminescence (Pn ECL) assay.	30 days after V116 vaccination (Day 30 for concomitant group and Day 60 for sequential group)
Secondary	Geometric Mean Fold Rise (GMFR) of Serotype-specific OPA	Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.	Day 1 (Baseline) and Day 30 post-vaccination for concomitant group. Day 1 (Baseline) and Day 60 post-vaccination for sequential group.
Secondary	Geometric Mean Fold Rise (GMFR) of Serotype-specific IgG	Activity for the serotypes contained in V116 (serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) will be determined using an Pn ECL assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.	Day 1 (Baseline) and Day 30 post-vaccination for concomitant group. Day 1 (Baseline) and Day 60 post-vaccination for sequential group.
Secondary	GMFR in Influenza Strain-specific HAI	Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay. GMFR is GMT 30 days after vaccination / GMT at Baseline.	Day 1 (Baseline) and Day 30
Secondary	Percentage of Participants with Influenza Strain-specific HAI Titer =1:40	Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.	Day 30
Secondary	Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI	Activity for the 4 strains contained in QIV vaccine will be determined using an HAI assay.	Day 30