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OpenTrials
Completed

NCT Number: NCT02573181

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 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
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Percentage of Participants With an Adverse Event (AE)

    Time frame: Up to Day 44 after vaccination

    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.

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

    Time frame: Up to Day 5 after vaccination

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

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

    Time frame: Up to Day 14 after vaccination

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

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

    Time frame: Baseline (Day 1) and Day 30 after vaccination

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

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

    Time frame: Baseline (Day 1) and Day 30 after vaccination

    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.

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

    Time frame: Baseline (Day 1) and Day 30 after vaccination

    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.

Secondary outcomes

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

    Time frame: Baseline (Day 1) and Day 30 after vaccination

    The OPA GMTs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Titer levels were determined with multiplexed OPA (MOPA-4).

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

    Time frame: Baseline (Day 1) and Day 30 after vaccination

    The GMFR (Day 30 GMT / Day 1 GMT) from baseline (Day 1) to Day 30 of each OPA serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).

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

    Time frame: Baseline (Day 1) and Day 30 after vaccination

    The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 9, 2015
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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