The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

Browse trials for

• Pneumococcal Infections 281

Keywords

• Pneumococcal vaccines

Pneumococcal Infections

281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.

This study's enrollment of 692 is above the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  V114

  Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.

  Biological: Pneumococcal Conjugate Vaccine (V114)

• Active comparator
  PNEUMOVAX® 23

  Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.

  Biological: PNEUMOVAX® 23

• Active comparator
  PREVNAR 13®

  Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.

  Biological: PREVNAR 13®

Interventions

• BiologicalPneumococcal Conjugate Vaccine (V114)

  15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

• BiologicalPNEUMOVAX® 23

  23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.

• BiologicalPREVNAR 13®

  13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.

Primary outcomes

1. Percentage of Participants With an Adverse Event

   An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.

   Time frame: All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination

2. Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups

   Injection-site AEs reported by \>=2% of participants in one or more vaccination groups were assessed.

   Time frame: Up to Day 14 postvaccination

3. Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups

   Systemic AEs reported by \>=2% of participants in one or more vaccination groups were assessed.

   Time frame: Up to Day 14 postvaccination

4. Percentage of Participants With a Serious Adverse Event

   A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

   Time frame: Up to 6 months postvaccination

5. Percentage of Participants With a Vaccine-related Serious Adverse Event

   A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.

   Time frame: Up to 6 months postvaccination

6. Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies

   Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.

   Time frame: One month postvaccination

Secondary outcomes

1. Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies

   OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)

   Time frame: One month postvaccination

Baseline characteristics

Publications

• Ermlich SJ, Andrews CP, Folkerth S, Rupp R, Greenberg D, McFetridge RD, Hartzel J, Marchese RD, Stek JE, Abeygunawardana C, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=50 years of age. Vaccine. 2018 Oct 29;36(45):6875-6882. doi: 10.1016/j.vaccine.2018.03.012. Epub 2018 Mar 17. PubMed 29559167 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf