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OpenTrials
Completed

NCT Number: NCT01513551

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)

The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older.

The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.

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Key information

Conditions

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

Age range

50 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

-Without fever for 72 hours prior to vaccination

Exclusion criteria

  • Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine
  • Known or suspected to be immunocompromised
  • Functional or anatomic asplenia
  • History of autoimmune disease
  • Evidence of dementia or cognitive impairment
  • Use of any immunosuppressive therapy
  • Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine
  • Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine
  • Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine
  • Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine
  • History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
  • Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine

Treatment and study plan

Pneumococcal Conjugate Vaccine (V114)

Biological

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.

PNEUMOVAX® 23

Biological

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.

Prevnar 13®

Biological

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

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

    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.

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

    Time frame: Up to Day 14 postvaccination

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

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

    Time frame: Up to Day 14 postvaccination

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

  4. Percentage of Participants With a Serious Adverse Event

    Time frame: Up to 6 months postvaccination

    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.

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

    Time frame: Up to 6 months postvaccination

    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.

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

    Time frame: One month postvaccination

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

Secondary outcomes

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

    Time frame: One month postvaccination

    OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (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 a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and PREVNAR 13® (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 20, 2012
Registry last updated
Dec 13, 2018

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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