A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01215188
First received: October 4, 2010
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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™


Condition Intervention Phase
Pneumococcal Infections
Biological: V114 Aluminum-adjuvanted
Biological: V114 Non-adjuvanted
Biological: Prevnar 13™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The number of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG (immunoglobulin G) antibody level for each of the 13 serotypes in common with Prevnar 13™ [ Time Frame: 30 days post-dose (dose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Concentrations (GMCs) of the antibody response to each of the 13 serotypes in common with Prevnar 13™ [ Time Frame: 30 days post-dose (dose 3 and dose 4) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG antibody levels for the 2 serotypes not in common with Prevnar 13™ [ Time Frame: 30 days post-dose (dose 3 and dose 4) ] [ Designated as safety issue: No ]

Enrollment: 1152
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V114 Aluminum-adjuvanted Biological: 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
Experimental: V114 Non-adjuvanted Biological: 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
Active Comparator: Prevnar 13™ Biological: Prevnar 13™
Four 0.5 mL IM doses of Prevnar 13™ at 2, 4, 6, and 12 to 15 months of age

Detailed Description:

A primary reason why this study was amended was to extend the comparison between V114 and Prevnar 13™ to all 13 serotypes in common, and to evaluate the response after dose 4 as a primary outcome measure.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy infants, age ≥ 6 to ≤ 12 weeks (≥ 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01215188     History of Changes
Other Study ID Numbers: V114-003
Study First Received: October 4, 2010
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Invasive pneumococcal disease
Pneumonia
Pneumococcal conjugate vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 10, 2014