Clinical trial NCT02531373: A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-08-24
Enrollment: 338
Sex: ALL
Minimum age (years): 2
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 effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.


Eligibility criteria: 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

Primary outcomes:
measure: Adults: Percentage of Participants With an Adverse Event
timeFrame: Up to 6 weeks after vaccination
measure: Infants: Percentage of Participants With an Adverse Event
timeFrame: Up to 1 month after Vaccination 4 (Month 11-15)
measure: Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
timeFrame: Up to time of Vaccination 4 (Month 10-13)
measure: Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
timeFrame: Up to 14 days after any vaccination
measure: Infants: Percentage of Participants With a Solicited Systemic Adverse Event
timeFrame: Up to 14 days after any vaccination
measure: Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
timeFrame: 1 month after Vaccination 3 (Month 5)
Secondary outcomes:
measure: Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
timeFrame: 1 month after vaccination
measure: Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
timeFrame: Baseline and 1 month after vaccination
measure: Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
timeFrame: 1 month after Vaccination 3 (Month 5)
measure: Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
timeFrame: Before Vaccination 4 (Month 10-13)
measure: Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
timeFrame: 1 month after Vaccination 4 (Month 11-15)
measure: Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
timeFrame: Before Vaccination 4 (Month 10-13)
measure: Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
timeFrame: 1 month after Vaccination 4 (Month 11-15)
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.