Overview

This trial is active, not recruiting.

Condition pneumococcal infections
Treatments v114 medium dose, v114 high dose, v114 medium dose with alternative carrier protein, v114 high dose with alternative carrier protein, prevnar 13™
Phase phase 1/phase 2
Sponsor Merck Sharp & Dohme Corp.
Start date September 2015
End date June 2017
Trial size 330 participants
Trial identifier NCT02531373, V114-005

Summary

This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Experimental)
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
v114 medium dose
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
(Experimental)
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
v114 high dose
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
(Experimental)
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.
v114 medium dose with alternative carrier protein
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
(Experimental)
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.
v114 high dose with alternative carrier protein
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
(Experimental)
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.
v114 medium dose
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
(Experimental)
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.
v114 high dose
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
(Experimental)
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
v114 medium dose with alternative carrier protein
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
(Experimental)
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
v114 high dose with alternative carrier protein
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
(Active Comparator)
Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12 to 15 months of age.
prevnar 13™
Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

Primary Outcomes

Measure
Percentage of Participants with an Adverse Event (Adult Participants)
time frame: Up to 1 month after vaccination
Percentage of Participants with an Adverse Event (Infant Participants)
time frame: Up to 1 month after Dose 4 (up to 14 months)
Percentage of Participants who Discontinued the Study Due to an Adverse Event (Infant Participants)
time frame: Up to 1 month after Dose 4 (up to 14 months)
Percentage of Participants with a Solicited Injection-site Adverse Event (Infant
time frame: Up to 1 month after Dose 4 (up to 14 months)
Percentage of Participants with a Solicited Systemic Adverse Event (Infant Participants)
time frame: Up to 1 month after Dose 4 (up to 14 months)
Geometric Mean Concentration of Serotype-specific Pneumococcal Antibody (Infant Participants)
time frame: One month after Dose 3 (5 months)

Secondary Outcomes

Measure
Geometric Mean Concentration of Serotype-specific Pneumococcal Antibody (Adult Participants)
time frame: One month after vaccination
Geometric Mean Fold-rise from Baseline of Serotype-specific Pneumococcal Antibody (Adult Participants)
time frame: Baseline and 1 month after vaccination
Percentage of Participants Achieving the Serotype-specific Threshold Value of >=0.35 mcg/mL at One Month after Dose 3 (Infant participants)
time frame: One month after Dose 3 (5 months)
Percentage of Participants Achieving the Serotype-specific Threshold Value of >=0.35 mcg/mL before Dose 4 (Infant participants)
time frame: Before Dose 4 (10 to 13 months)
Percentage of Participants Achieving the Serotype-specific Threshold Value of >=0.35 mcg/mL at One Month after Dose 4 (Infant participants)
time frame: One month after Dose 4 (11 to 14 months)
Geometric Mean Concentration of Serotype-specific Pneumococcal Antibody before Dose 4 (Infant Participants)
time frame: Before Dose 4 (10 to 13 months)
Geometric Mean Concentration of Serotype-specific Pneumococcal Antibody at One Month After Dose 4 (Infant Participants)
time frame: One month after Dose 4 (11 to 14 months)

Eligibility Criteria

Male or female participants from 2 months up to 49 years old.

Inclusion Criteria: Adult Cohort: 18 to 49 years and in good health - Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine. Infant Cohort: approximately 2 months (42 to 90 days) and in good health. Exclusion Criteria: Adult cohort: Prior administration of any pneumococcal vaccine - History of invasive pneumococcal disease - Known hypersensitivity to any vaccine component - Known or suspected impairment of immune function - Coagulation disorder contraindicating intramuscular vaccination - Received a blood transfusion or blood products within 6 months - Participated in another clinical study of an investigational product within 2 months - Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine - Known hypersensitivity to any vaccine component - Known or suspected impairment of immune function - History of congenital or acquired immunodeficiency - Has or mother has documented Human Immunodeficiency virus (HIV) infection - Has or mother has documented hepatitis B surface antigen positive result - Functional or anatomic asplenia - History of failure to thrive - Coagulation disorder contraindicating intramuscular vaccination - History of autoimmune disease or autoimmune disorder - Known neurologic or cognitive behavioral disorder - Received systemic corticosteroids within 14 days - Received other licensed non-live vaccine within 14 days - Received other licensed live virus vaccine within 30 days - Received a blood transfusion or blood products - Participated in another clinical study of an investigational product - History of invasive pneumococcal disease

Additional Information

Official title A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..