The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
133
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.
Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
Meitetsu Hospital ( Site 2805)
Nagoya, Aichi-ken, Japan
Sotobo Children's Clinic ( Site 2807)
Isumi, Chiba, Japan
Hidaka Children's Clinic ( Site 2803)
Dazaifu, Fukuoka, Japan
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs were injection site erythema (redness), injection site induration (hard lump), injection site pain and injection site swelling.
Time frame: Day 1 to Day 14 post each vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs were decreased appetite (appetite loss), somnolence (drowsiness), irritability and urticaria (hives/welts).
Time frame: Day 1 to Day 14 post each vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
An SAE is an AE that 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. Relatedness of an SAE to the study vaccine was determined by the investigator.
Time frame: Up to 4 weeks post vaccination 4 (~14.5 months)
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
Serotype-specific pneumococcal IgG antibody was measured using pneumococcal electrochemiluminescence (PnECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
Time frame: One month post vaccination 3 (~3 months after Vaccination 1)
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
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Isesaki Municipal Hospital ( Site 2806)
Isesaki, Gunma, Japan
Kawasaki Municipal Hospital ( Site 2802)
Kawasaki, Kanagawa, Japan
Yokosuka Kyosai Hospital ( Site 2804)
Yokosuka, Kanagawa, Japan
Suita Municipal Hospital ( Site 2801)
Suita, Osaka, Japan
Kobayashi Pediatric Clinic ( Site 2816)
Fujieda, Shizuoka, Japan
Nishida Kodomo Clinic ( Site 2811)
Tama, Tokyo, Japan
Fukui Aiiku Hospital ( Site 2809)
Fukui, Japan
...and 4 more locations
The anti-pneumococcal polysaccharide (PnPs) serotype-specific IgG Geometric Mean Concentrations (GMCs) were determined using an electrochemiluminescence assay.
Time frame: 1 month post vaccination 3 (~3 months after Vaccination 1)
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
DTaP-IPV antibody titers were measured by neutralization assay (diphtheria toxin and poliovirus 1/2/3), particle agglutination assay (tetanus toxin) and enzyme-linked immunosorbent assay (ELISA) methodology (pertussis PT and pertussis FHA) 1 month post vaccination 3. Threshold values were: Diphtheria toxin level ≥0.1 IU/mL, Pertussis PT level ≥10 EU/mL, Pertussis FHA level ≥10 EU/mL, Tetanus toxin level ≥0.01 IU/mL, Neutralizing antibody (NA) titers of Polio virus types 1/2/3 ≥1:8.
Time frame: 1 month post vaccination 3 (~3 months after Vaccination 1)