Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)

NCT02573181 | Completed Phase 2 Results DMC

• 1 other identifier: V114-007
• Study Type: interventional
• Target: 253
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With an Adverse Event (AE)

  An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  Up to Day 44 after vaccination

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

  Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.

  Up to Day 5 after vaccination

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

  Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.

  Up to Day 14 after vaccination

• Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)

  The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.

  Baseline (Day 1) and Day 30 after vaccination

• Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)

  The GMFR (Day 30 geometric mean concentration \[GMC\] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.

  Baseline (Day 1) and Day 30 after vaccination

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

  The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.

  Baseline (Day 1) and Day 30 after vaccination

Secondary Outcomes (3)

• Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)

  Baseline (Day 1) and Day 30 after vaccination

• Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)

  Baseline (Day 1) and Day 30 after vaccination

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

  Baseline (Day 1) and Day 30 after vaccination

Study Arms (2)

V114

EXPERIMENTAL

Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of V114 on Day 1.

Biological: V114

Prevnar 13™

ACTIVE COMPARATOR

Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.

Biological: Prevnar 13™

Interventions

V114 BIOLOGICAL

V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose.

V114

Prevnar 13™ BIOLOGICAL

Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose.

Prevnar 13™

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Is in good health (any underlying chronic illness must be documented to be in stable condition)
• Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1 year prior to study entry
• Is a male or postmenopausal female

You may not qualify if:

• Has received prior administration of any pneumococcal vaccine other than 23-valent pneumococcal polysaccharide vaccine
• Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
• Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
• Is known or suspected impairment of immune function
• Has 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
• Has a 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
• Has 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
• Is a 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)

• Peterson JT, Stacey HL, MacNair JE, Li J, Hartzel JS, Sterling TM, Benner P, Tamms GM, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults >/=65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Hum Vaccin Immunother. 2019;15(3):540-548. doi: 10.1080/21645515.2018.1532250. Epub 2018 Nov 14.

  PMID: 30427749 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: October 8, 2015
• First Posted: October 9, 2015
• Study Start: October 30, 2015
• Primary Completion: January 28, 2016
• Study Completion: January 28, 2016
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share