A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
- Conditions
- Pneumococcal Infections
- Registration Number
- NCT02987972
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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™.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1051
- Infant approximately 2 months of age (42 days to 90 days), inclusive
- In good health
- 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
- Known neurologic or cognitive behavioral disorder
- Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
- Prior administration of a blood transfusion or blood products, including immunoglobulin
- Participated in another clinical trial of an investigational product
- History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 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 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 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 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 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 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 Outcome Measures
Name Time Method 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) Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
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) Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
Trial Locations
- Locations (49)
Birmingham Pediatric Research ( Site 0043)
🇺🇸Birmingham, Alabama, United States
Southeastern Pediatric Associates, P.A. ( Site 0079)
🇺🇸Dothan, Alabama, United States
Children's Clinic of Jonesboro, PA ( Site 0054)
🇺🇸Jonesboro, Arkansas, United States
Premier Health Research Center, LLC ( Site 0035)
🇺🇸Downey, California, United States
Sherif Khamis MD, Inc. ( Site 0044)
🇺🇸Palmdale, California, United States
Kaiser Permanente - Roseville ( Site 0045)
🇺🇸Roseville, California, United States
Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)
🇺🇸Sacramento, California, United States
Kentucky Pediatric/Adult Research Inc ( Site 0037)
🇺🇸Bardstown, Kentucky, United States
University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)
🇺🇸Louisville, Kentucky, United States
ACC Pediatric Research ( Site 0039)
🇺🇸Haughton, Louisiana, United States
Scroll for more (39 remaining)Birmingham Pediatric Research ( Site 0043)🇺🇸Birmingham, Alabama, United States