This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
2,409
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 ml dose
Percentage of Participants With a Solicited Injection-site Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Time frame: Up to Day 14 after each study vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).
Time frame: Up to Day 14 after each study vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Time frame: Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
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Premier Health Research Center, LLC ( Site 0005)
Downey, California, United States
Beach Pediatrics ( Site 0040)
Huntington Beach, California, United States
Khruz Biotechnology Research Institute ( Site 0006)
San Diego, California, United States
Kaiser Permanente - San Jose ( Site 0036)
San Jose, California, United States
Kaiser Permanente - Santa Clara ( Site 0027)
Santa Clara, California, United States
Children's Research, LLC ( Site 0025)
Lake Mary, Florida, United States
Advanced Research For Health Improvement LLC ( Site 0030)
Naples, Florida, United States
Pediatric Partners, P.A. ( Site 0010)
Overland Park, Kansas, United States
Novak Center for Childrens Health ( Site 0033)
Louisville, Kentucky, United States
Medpharmics, LLC ( Site 0037)
Metairie, Louisiana, United States
...and 66 more locations
Time frame: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time frame: Before Vaccination 4 (10-13 months after Vaccination 1)
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time frame: 30 days after Vaccination 4 (11-14 months after Vaccination 1)
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time frame: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)