Clinical trial NCT02037984: Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)
Official title: A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Streptococcus Pneumoniae Infection
Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-01-16
Enrollment: 341
Sex: ALL
Minimum age (years): 6
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2.


Eligibility criteria: Inclusion Criteria

Infants:

- Healthy and able to attend all scheduled visits.

Adults:

- Highly unlikely to conceive from vaccination to 6 weeks after administration of the vaccine.

Exclusion Criteria

Infants and Adults:

* Prior administration of any pneumococcal vaccine, any non-live vaccine within 14 days, or any live vaccine within 30 days.
* History of invasive pneumococcal disease.
* Known hypersensitivity to any vaccine component.
* Received systemic corticosteroids within 14 days of first vaccination.
* Known or suspected impairment of immune function.
* Febrile illness within 72 hours before vaccination.
* Received blood transfusion or blood products within 30 days. Infants
* Mother has documented human immunodeficiency virus or is hepatitis B surface antigen positive.
* Has asplenia or failure to thrive.

Adults:

- Is breastfeeding.

Primary outcomes:
measure: Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE)
timeFrame: Up to 14 days
measure: Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to 14 days
measure: Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE)
timeFrame: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
measure: Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
timeFrame: Month 7 (1 month PD3)
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
timeFrame: Month 7 (1 month PD3)
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
timeFrame: Month 7 (1 month PD3)
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
timeFrame: Month 7 (1 month PD3)
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
timeFrame: Month 7 (1 month PD3)
measure: Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
timeFrame: Month 7 (1 month PD3)
measure: Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
timeFrame: Month 7 (1 month PD3)
Secondary outcomes:
measure: Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)
timeFrame: Month 7 (1 month PD3)
measure: Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)
timeFrame: Month 7 (1 month PD3)
measure: Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®
timeFrame: One month following the 4th vaccination (approximately 13 to 16 months of age).
measure: Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®
timeFrame: One month following the 4th vaccination (approximately 13 to 16 months of age).
measure: Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®
timeFrame: One month following the 4th vaccination (approximately 13 to 16 months of age).
measure: Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®
timeFrame: One month following the 4th vaccination (approximately 13 to 16 months of age).
measure: Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®
timeFrame: One month following the 4th vaccination (approximately 13 to 16 months of age).
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants
timeFrame: One month following the 4th vaccination (approximately 13 to 16 months of age)
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
timeFrame: Month 2 (1 month after a single vaccination)
measure: Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults
timeFrame: Month 2 (1 month after a single vaccination)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Rupp R, Hurley D, Grayson S, Li J, Nolan K, McFetridge RD, Hartzel J, Abeygunawardana C, Winters M, Pujar H, Benner P, Musey L. A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Hum Vaccin Immunother. 2019;15(3):549-559. doi: 10.1080/21645515.2019.1568159. Epub 2019 Feb 15.