A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

Merck Sharp & Dohme LLC1,051 enrolled

Overview

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™.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,051

Conditions

Pneumococcal Infections

Interventions

V114 Lot 1BIOLOGICAL

Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

V114 Lot 2BIOLOGICAL

Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

Prevnar 13™BIOLOGICAL

Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 12 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Infant approximately 2 months of age (42 days to 90 days), inclusive * In good health Exclusion Criteria: * 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

Locations (49)

Outcomes

Primary Outcomes

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

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.

Time frame: 1 month post vaccination 3 (Month 5)

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

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.

Time frame: 1 month post Vaccination 3 (Month 5)

Percentage of Participants Who Experience at Least 1 Adverse Event

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.

Time frame: Up to 1 month post Vaccination 4 (up to 14 months)

Percentage of Participants Who Discontinued From the Study Due to an Adverse Event

The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.

Time frame: Up to 1 month post Vaccination 4 (up to 14 months)

Percentage of Participants With a Solicited Injection-site Adverse Event

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.

Data from ClinicalTrials.gov

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