Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)

Merck Sharp & Dohme LLC606 enrolled

Overview

The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

606

Conditions

Pneumococcal Infections

Interventions

V114BIOLOGICAL

V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration

Prevnar 13®BIOLOGICAL

Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

Eligibility

Sex: ALLMin age: 7 MonthsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria * Not be pregnant or breastfeeding * Not be a woman of childbearing potential * If of a woman of childbearing potential, agree to follow the contraceptive guidance during the treatment period and for at least 6 weeks after the last dose of study intervention * 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 * History of invasive pneumococcal disease (IPD) * Known hypersensitivity to any component of the PCV or any diphtheria toxoid-containing vaccine * Had a recent febrile illness occurring within 72 hours prior to receipt of study vaccine * Known or suspected impairment of immunological function * History of congenital or acquired immunodeficiency * Has or his/her mother has a documented human immunodeficiency virus (HIV) infection * Known or history of functional or anatomic asplenia * Has failure to thrive based on the clinical judgement of the investigator * Has a bleeding disorder contraindicating intramuscular vaccination * Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders) * Has known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders * Is 7 to 23 months of age and has received a dose of a pneumococcal vaccine prior to study entry based on medical record. Participants ≥2 years of age could have received a PCV at least 8 weeks prior to study entry as follows: a partial regimen of Prevnar™,Synflorix™, or Prevnar 13™ or a full regimen of Prevnar™ or Synflorix™ based on local guidelines. Participants should not have received any dose of a pneumococcal polysaccharide vaccine * Meets one or more of the following systemic corticosteroid exclusion criteria: has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing \>10 kg) for ≥14 consecutive days and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization; has received or is expected to receive systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days prior to any dose of study vaccine; or is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study (Note: Topical, ophthalmic and inhaled steroids are permitted) * Has received other licensed non-live vaccines within 14 days before receipt of study vaccine. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine or at least 15 days after receipt of study vaccine * Has received a licensed live vaccine within 30 days before receipt of study vaccine * Has received a blood transfusion or blood products, including immunoglobulins, within 6 months before receipt of study vaccine * Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study

Locations (26)

Outcomes

Primary Outcomes

Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months

The geometric mean concentration (GMC) of immunoglobulin G (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 two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

Time frame: 30 days post last vaccination

GMC of Serotype-specific IgG - Schedule B: 12-23 Months

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 two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.

Time frame: 30 days post last vaccination

GMC of Serotype-specific IgG - Schedule C: 2-17 Years

Time frame: 30 days post vaccination

Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months

An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized.

Data from ClinicalTrials.gov

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Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)

Espoo, Finland

Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)

Helsinki, Finland

Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)

Helsinki, Finland

Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)

Jarvenpaa, Finland

Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)

Kokkola, Finland

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)

Oulu, Finland

Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)

Pori, Finland

Seinajoki Vaccine Research Center ( Site 0010)

Seinäjoki, Finland

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)

Tampere, Finland

Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)

Turku, Finland

...and 16 more locations

Secondary Outcomes

Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months

Time frame: 30 days post final vaccination

Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months

Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.

Time frame: 30 days post final vaccination

Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years

Time frame: 30 days post vaccination