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

NCT02547649 | Completed Phase 2 Results DMC

• 1 other identifier: V114-006
• Study Type: interventional
• Target: 690
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (6)

• 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.

  Up to 14 days after vaccination

• 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.

  Up to 14 days after vaccination

• 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.

  Up to 14 days after vaccination

• Percentage of Participants With a Serious Adverse Event (SAE)

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

  Up to 30 days after vaccination

• 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.

  Up to 30 days after vaccination

• 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).

  Day 30 (one month after vaccination)

Secondary Outcomes (3)

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

  Day 30 (one month after vaccination)

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

  Baseline and Day 30 (one month after vaccination)

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

  Baseline and Day 30 (one month after vaccination)

Study Arms (3)

V114 Formulation A

EXPERIMENTAL

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

Biological: V114-A

V114 Formulation B

EXPERIMENTAL

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

Biological: V114-B

Prevnar 13®

ACTIVE COMPARATOR

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

Biological: Prevnar 13®

Interventions

V114-A BIOLOGICAL

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).

V114 Formulation A

V114-B BIOLOGICAL

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).

V114 Formulation B

Prevnar 13® BIOLOGICAL

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.

Prevnar 13®

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 30648919 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 11, 2015
• Study Start: October 8, 2015
• Primary Completion: January 20, 2016
• Study Completion: January 20, 2016
• Last Updated: April 16, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share