A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Infections

Treatments: Biological: V114 Non-adjuvanted; Biological: V114 Aluminum-adjuvanted; Biological: Prevnar 13®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01215188

V114-003 (Other Identifier)

Details and patient eligibility

About

This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common Prevnar 13®

Enrollment: 1,152 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants ≥ 42 days to ≤ 89 days.
• Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to allow the child to participate by giving written informed consent.
• Afebrile, with a rectal temperature <38.1°C (<100.5°F) or axillary temperature <37.8°C (<100.0°F) on day of vaccination.
• Participant's parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card).
• Participant is able to attend all scheduled visits and to comply with the study procedures.
• Participant's parent/legal guardian has access to a telephone.

Exclusion criteria

• Prior administration of any pneumococcal vaccine.
• Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
• Known or suspected impairment of immunological function.
• Participant has a history of congenital or acquired immunodeficiency (e.g., splenomegaly).
• Participant or his/her mother has documented human immunodeficiency virus (HIV) infection.
• Functional or anatomic asplenia.
• History of autoimmune disease including multiple sclerosis (MS), systemic lupus, polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders.
• Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive developmental disorder, and related disorders.
• Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Participants on intramuscular, oral, or intravenous corticosteroid treatment should be excluded if they are receiving or expected to receive in the period from 30 days prior to Visit 1 through Visit 6 (30 days post-dose 4) more than 2 mg/kg per day of prednisone (or its equivalent), or more than 20 mg/d if they weigh more than 10 kg and are not otherwise immunocompromised. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease.
• Participant has received other licensed non-live vaccines within the 14 days before receipt of study vaccine.
• Participant has received a licensed live virus vaccine within the 30 days prior of receipt of study vaccine.
• Prior receipt of a blood transfusion or blood products, including immunoglobulins.
• Investigational drugs or vaccines received within the 2 months before receipt of study vaccine.
• Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study.
• History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
• A recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F]) occurring within 72 hours before receipt of study vaccine.
• History of failure to thrive.
• Participant has a coagulation disorder contraindicating IM vaccination.
• Participant and his/her mother have documented hepatitis B surface antigen-positive.
• Any infant who cannot be adequately followed for safety according to the protocol plan.
• Participant's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
• Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,152 participants in 3 patient groups

V114 Aluminum-adjuvanted

Experimental group

Description:

Four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.

Treatment:

Biological: V114 Aluminum-adjuvanted

V114 Non-adjuvanted

Experimental group

Description:

Four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.

Treatment:

Biological: V114 Non-adjuvanted

Prevnar 13®

Active Comparator group

Description:

Four IM doses at 0.5 mL of Prevnar 13® at 2, 4, 6, and 12 to 15 months of age.

Treatment:

Biological: Prevnar 13®