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 Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 338
- Primary Endpoint
- Adults: Percentage of Participants With an Adverse Event
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 2 Months to 49 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Adults: Percentage of Participants With an Adverse Event
Time Frame: Up to 6 weeks 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.
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
Time Frame: Up to 14 days after any vaccination
Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Time Frame: 1 month after Vaccination 3 (Month 5)
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Infants: Percentage of Participants With a Solicited Systemic Adverse Event
Time Frame: Up to 14 days after any vaccination
Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
Infants: Percentage of Participants With an Adverse Event
Time Frame: Up to 1 month after Vaccination 4 (Month 11-15)
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.
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
Time Frame: Up to time of Vaccination 4 (Month 10-13)
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.
Secondary Outcomes
- Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3(1 month after Vaccination 3 (Month 5))
- Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4(Before Vaccination 4 (Month 10-13))
- Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies(1 month after Vaccination 4 (Month 11-15))
- Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies(1 month after vaccination)
- Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4(1 month after Vaccination 4 (Month 11-15))
- Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies(Baseline and 1 month after vaccination)