V114
BiologicalV114 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.
NCT Number: NCT02573181
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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Notify Me65 year and older
All sexes
Interventional
Phase 2
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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™ 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.
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.
Time frame: Up to Day 5 after vaccination
Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.
Time frame: Up to Day 14 after vaccination
Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.
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.
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.
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.
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).
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).
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).
Merck Sharp & Dohme LLC
Industry
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
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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