Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)

Phase 3

Completed

Conditions: Pneumococcal Vaccines
Pneumococcal Infections

Registration Number: NCT03893448

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1720

Inclusion Criteria

Is healthy (based on a review of medical history and physical examination) in the clinical judgement of the investigator
Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria

Has a history of invasive pneumococcal disease (IPD; positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
Has any contraindication to the concomitant study vaccines being administered in the study.
Had a recent febrile illness (rectal temperature ≥38.1°C [=100.5°F] or axillary temperature ≥37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3	One month after Vaccination 3 (Month 7)	Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
GMC of Anti-PnP IgG Ab One Month After Vaccination 4	One month after Vaccination 4 (Month 13 to Month 16)	The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™	Up to 14 days after each vaccination with either V114 or Prevnar 13™	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Percentage of Participants With Solicited Systemic AEs	Up to 14 days after each vaccination with either V114 or Prevnar 13™	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts.
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)	From Day 1 up to 6 months after Vaccination 4 (up to 21 months)	An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized.
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3	One month after Vaccination 3 (Month 7)	The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3	One month after Vaccination 3 (Month 7)	Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL.
Hepatitis A Antibody Response Rate One Month After Vaccination 4	One month after Vaccination 4 (Month 13 to Month 16)	Antibody response rates to hepatitis A were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3	One month after Vaccination 3 (Month 7)	Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3	One month after Vaccination 3 (Month 7)	Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4	One month after Vaccination 4 (Month 13 to Month 16)	Antibody responses to measles were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes	One month after Vaccination 3 (Month 7)	Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3	One month after Vaccination 3 (Month 7)	Pertussis antibody GMCs were measured using Luminex Assay.
Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4	One month after Vaccination 4 (Month 13 to Month 16)	Antibody responses to varicella-zoster virus were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4	One month after Vaccination 4 (Month 13 to Month 16)	Serotype 3-specific anti-PnP GMC were measured with PnECL.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3	One month after Vaccination 3 (Month 7)	Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for Serotype 3.
Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4	One month after Vaccination 4 (Month 13 to Month 16)	Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 ug/mL are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes	One month after Vaccination 3 (Month 7)	Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes	One month after Vaccination 4 (Month 13 to Month 16)	Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported.
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3	One month after Vaccination 3 (Month 7)	Serotype 3-specific anti-PnP GMC was measured with PnECL.

Trial Locations

Locations (81): Alabama Clinical Therapeutics ( Site 0159)
🇺🇸
Birmingham, Alabama, United States
Southeastern Pediatric Associates, P.A. ( Site 0107)
🇺🇸
Dothan, Alabama, United States
South Alabama Pediatrics ( Site 0263)
🇺🇸
Opp, Alabama, United States
Northwest Arkansas Pediatric Clinic ( Site 0172)
🇺🇸
Fayetteville, Arkansas, United States
Children's Clinic of Jonesboro, PA ( Site 0184)
🇺🇸
Jonesboro, Arkansas, United States
Advanced Clinical Research - Rancho Paseo ( Site 0163)
🇺🇸
Banning, California, United States
Altissima Clinical Research LLC ( Site 0213)
🇺🇸
Bellflower, California, United States
Southland Clinical Research Center ( Site 0187)
🇺🇸
Bellflower, California, United States
Premier Health Research Center, LLC ( Site 0121)
🇺🇸
Downey, California, United States
Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282)
🇺🇸
Oakland, California, United States
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Alabama Clinical Therapeutics ( Site 0159)
🇺🇸Birmingham, Alabama, United States