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Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)

Primary Purpose

Pneumococcal Infections

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

V114-A

V114-B

Prevnar 13®

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Good health; any underlying chronic illness must be documented to be in stable condition
Highly unlikely to conceive through 6 weeks after administration of the study vaccine

Exclusion Criteria:

Prior administration of any pneumococcal vaccine
History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease
Known hypersensitivity to any vaccine component
Known or suspected impairment of immune function
Received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination
Coagulation disorder contraindicating intramuscular vaccination
Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease
Received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
Participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study
Breast feeding
User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

V114 Formulation A

V114 Formulation B

Prevnar 13®

Arm Description

Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1

Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1

Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1

Outcomes

Primary Outcome Measures

Percentage of Participants With an Adverse Event (AE)

The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.

Percentage of Participants With a Solicited Systemic Adverse Event (AE)

The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.

Percentage of Participants With a Serious Adverse Event (SAE)

The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.

Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)

The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.

Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination

The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).

Secondary Outcome Measures

Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination

The IgG GMCs of each common pneumococcal serotype (CS) and V114-specific pneumococcal serotype (VS) were determined for each arm. Concentrations were determined with pneumococcal electrochemiluminescence (PnECL).

Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)

The percentage of participants with ≥4-fold rise from baseline in OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.

Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies

The percentage of participants with ≥4-fold rise from baseline in IgG GMCs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.

Full Information

NCT ID

NCT02547649

First Posted

September 10, 2015

Last Updated

April 9, 2019

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02547649

Brief Title

Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)

Official Title

A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

October 8, 2015 (Actual)

Primary Completion Date

January 20, 2016 (Actual)

Study Completion Date

January 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants ≥50 years of age in good health.

6. Conditions and Keywords

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

Pneumococcal Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

690 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V114 Formulation A

Arm Type

Experimental

Arm Description

Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1

Arm Title

V114 Formulation B

Arm Type

Experimental

Arm Description

Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1

Arm Title

Prevnar 13®

Arm Type

Active Comparator

Arm Description

Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1

Intervention Type

Biological

Intervention Name(s)

V114-A

Intervention Description

Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).

Intervention Type

Biological

Intervention Name(s)

V114-B

Intervention Description

Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).

Intervention Type

Biological

Intervention Name(s)

Prevnar 13®

Intervention Description

Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose.

Primary Outcome Measure Information:

Title

Percentage of Participants With an Adverse Event (AE)

Description

Time Frame

Up to 14 days after vaccination

Title

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

Description

The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.

Time Frame

Up to 14 days after vaccination

Title

Percentage of Participants With a Solicited Systemic Adverse Event (AE)

Description

The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.

Time Frame

Up to 14 days after vaccination

Title

Percentage of Participants With a Serious Adverse Event (SAE)

Description

The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.

Time Frame

Up to 30 days after vaccination

Title

Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)

Description

The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.

Time Frame

Up to 30 days after vaccination

Title

Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination

Description

The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).

Time Frame

Day 30 (one month after vaccination)

Secondary Outcome Measure Information:

Title

Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination

Description

Time Frame

Day 30 (one month after vaccination)

Title

Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)

Description

Time Frame

Baseline and Day 30 (one month after vaccination)

Title

Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies

Description

Time Frame

Baseline and Day 30 (one month after vaccination)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Good health; any underlying chronic illness must be documented to be in stable condition Highly unlikely to conceive through 6 weeks after administration of the study vaccine Exclusion Criteria: Prior administration of any pneumococcal vaccine History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease Known hypersensitivity to any vaccine component Known or suspected impairment of immune function Received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination Coagulation disorder contraindicating intramuscular vaccination Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease Received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion. Participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study Breast feeding User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

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

30648919

Citation

Stacey HL, Rosen J, Peterson JT, Williams-Diaz A, Gakhar V, Sterling TM, Acosta CJ, Nolan KM, Li J, Pedley A, Benner P, Abeygunawardana C, Kosinski M, Smith WJ, Pujar H, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults. Hum Vaccin Immunother. 2019;15(3):530-539. doi: 10.1080/21645515.2018.1532249. Epub 2019 Jan 16.

Results Reference

derived

Learn more about this trial

Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)

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