A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pneumococcal Infections
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 1051
- Locations
- 49
- Primary Endpoint
- Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infant approximately 2 months of age (42 days to 90 days), inclusive
- •In good health
Exclusion Criteria
- •Prior administration of any pneumococcal vaccine
- •Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
- •Known or suspected impairment of immunological function
- •History of congenital or acquired immunodeficiency (eg, splenomegaly)
- •Mother has documented human immunodeficiency virus (HIV) infection
- •Mother has documented hepatitis B surface antigen-positive test result
- •Known or history of functional or anatomic asplenia
- •History of failure to thrive
- •History of a coagulation disorder
- •History of autoimmune disease
Outcomes
Primary Outcomes
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
Time Frame: 1 month post vaccination 3 (Month 5)
Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
Time Frame: Up to 1 month post Vaccination 4 (up to 14 months)
The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3
Time Frame: 1 month post Vaccination 3 (Month 5)
Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.
Percentage of Participants With a Solicited Injection-site Adverse Event
Time Frame: Up to 14 days post any vaccination
Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.
Percentage of Participants With a Solicited Systemic Adverse Event
Time Frame: Up to 14 days post any vaccination
Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.
Percentage of Participants Who Experience at Least 1 Adverse Event
Time Frame: Up to 1 month post Vaccination 4 (up to 14 months)
An adverse event (AE) is defined as 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. The percentage of participants with one or more AEs was assessed.
Secondary Outcomes
- Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4(Before Vaccination 4 (Month 10 to 13))
- Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4(1 month post vaccination 4 (Month 11-14))