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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Infections

Treatments: Biological: Prevnar 13™; Biological: V114 Lot 1; Biological: V114 Lot 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02987972

2016-001117-25 (EudraCT Number)

V114-008

Details and patient eligibility

About

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™.

Enrollment: 1,051 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,051 participants in 3 patient groups

V114 Lot 1

Experimental group

Description:

Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

Treatment:

Biological: V114 Lot 1

V114 Lot 2

Experimental group

Description:

Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

Treatment:

Biological: V114 Lot 2

Prevnar 13™

Active Comparator group

Description:

Infants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

Treatment:

Biological: Prevnar 13™