Clinical trial NCT01215188: A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)
Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13™ in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Infections
Keywords: Invasive pneumococcal disease
Pneumonia
Pneumococcal conjugate vaccine
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-10-06
Enrollment: 1152
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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®


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.

Primary outcomes:
measure: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3
timeFrame: One month postvaccination 3
measure: IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3
timeFrame: One month postvaccination 3
measure: IgG GMCs for Postvaccination 4
timeFrame: One month postvaccination 4
measure: Number of Participants With an Adverse Event (AE)
timeFrame: Up to Day 14 postvaccination
measure: Number of Participants With an Injection-site AE
timeFrame: Up to Day 14 postvaccination
measure: Number of Participants With a Systemic AE
timeFrame: Up to Day 14 postvaccination
measure: Number of Participants With a Serious Adverse Event (SAE)
timeFrame: Up to one month after last dose of study vaccine
measure: Number of Participants Who Discontinued the Study Due to an AE
timeFrame: Up to Day 14 postvaccination
Secondary outcomes:
measure: Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3
timeFrame: One month postvaccination 3
measure: Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4
timeFrame: One month postvaccination 4
measure: OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3
timeFrame: One month postvaccination 3
measure: OPA GMTs as Measured by MOPA4 for Postvaccination 4
timeFrame: One month postvaccination 4
measure: Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4
timeFrame: One month postvaccination 4
measure: Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4
timeFrame: One month postvaccination 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.