Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: V114, Aluminum NonadjuvantedBiological: Prevnar™Biological: V114, Aluminum Adjuvanted
- Registration Number
- NCT01215175
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.
- Detailed Description
The study was extended to obtain additional sera from adult participants to support further development, validation, and performance of anti-pneumococcal antibody assays.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V114 Nonadjuvanted-Toddler Cohort V114, Aluminum Nonadjuvanted Healthy toddlers (12-15 months of age) participants who completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of non-adjuvanted V114 on Day 1. Prevnar™ - Adult Cohort Prevnar™ Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1. V114 Adjuvanted -Toddler Cohort V114, Aluminum Adjuvanted Healthy toddler (12-15 months of age) participants who had completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. V114 Adjuvanted -Adult Cohort V114, Aluminum Adjuvanted Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. Prevnar™- Toddler Cohort Prevnar™ Healthy toddlers (12-15 months of age) participants who had previously completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.
- Primary Outcome Measures
Name Time Method Adult: Percentage of Participants With Any Adverse Event Up to Day 14 after vaccination An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Toddler: Percentage of Participants With Any Serious Adverse Event Up to Day 14 after vaccination 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.
Toddler: Percentage of Participants With Any Adverse Event Up to Day 14 after vaccination An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Adult: Percentage of Participants With Any Vaccine-related Adverse Event Up to Day 14 after vaccination An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.
Toddler: Percentage of Participants With Any Vaccine-related Adverse Event Up to Day 14 after vaccination An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.
Adult: Percentage of Participants With Any Serious Adverse Event Up to Day 14 after vaccination 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.
- Secondary Outcome Measures
Name Time Method Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Day 30 after vaccination Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Day 30 after vaccination Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL Day 30 after vaccination Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Day 30 after vaccination OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies Day 30 after vaccination Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Day 30 after vaccination OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 Day 30 after vaccination OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Day 30 after vaccination OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay