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

NCT ID: NCT01215188

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-14
• Study Completion Date: 2012-07-31

Brief Summary

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®

Conditions

Pneumococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

V114 Aluminum-adjuvanted

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.

Group Type: EXPERIMENTAL

V114 Aluminum-adjuvanted

Intervention Type: BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

V114 Non-adjuvanted

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.

Group Type: EXPERIMENTAL

V114 Non-adjuvanted

Intervention Type: BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.

Prevnar 13®

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

Group Type: ACTIVE_COMPARATOR

Prevnar 13®

Intervention Type: BIOLOGICAL

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.

Interventions

V114 Aluminum-adjuvanted

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

Intervention Type: BIOLOGICAL

V114 Non-adjuvanted

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.

Intervention Type: BIOLOGICAL

Prevnar 13®

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Greenberg D, Hoover PA, Vesikari T, Peltier C, Hurley DC, McFetridge RD, Dallas M, Hartzel J, Marchese RD, Coller BG, Stek JE, Abeygunawardana C, Winters MA, MacNair JE, Pujar NS, Musey L. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Vaccine. 2018 Oct 29;36(45):6883-6891. doi: 10.1016/j.vaccine.2018.02.113. Epub 2018 Sep 21.

Reference Type: DERIVED

PMID: 30244873 (View on PubMed)

Other Identifiers

V114-003

Identifier Type: OTHER

Identifier Source: secondary_id

V114-003

Identifier Type: -

Identifier Source: org_study_id