Back to list

Merck V114 / Prevnar

University of North Carolina at Chapel Hill


Description

To Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 (pneumococcal vaccine) in Healthy Infants


Keywords:

Pediatrics


Category:

Drug or Biologic
Phase:3

Qualifications

 


Age
0 - 0 years


Gender
Any


Study Population

Healthy infants enrolled at approximately 2 months of age (from 42 to 90 days [inclusive]).


Investigator

Robert Morgan

UNC Hospitals - UNCPN

For questions, contact:

Judith Mulvihill
judith.mulvihill@unchealth.unc.edu
(984) 444-7967


Recruitment Period End

July 1, 2020

Location

Primary Location
Capitol Pediatrics & Adolescent Center UNCPN
3801 Computer Dr, Raleigh, NC 27609, USA
Secondary Location
N/A

Study Qualifications

Gender Any

Age Range 0 - 0 years

Participant qualification(s) A participant will be eligible for inclusion in the study if the participant: 1. Is healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator. 2. Is male or female, approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent. 3. Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent. The legally acceptable representative may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.

Not eligible if: The participant must be excluded from the study if the participant: 1. Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. 2. Has a known hypersensitivity to any component of the PCV, any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine. 3. Has any contraindication to the concomitant study vaccines being administered in the study. 4. *Had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) occurring within 72 hours prior to receipt of study vaccine. 5. Has a known or suspected impairment of immunological function. 6. Has a history of congenital or acquired immunodeficiency. 7. Has or his/her mother has a documented human immunodeficiency virus (HIV) infection. 8. Has or his/her mother has a documented hepatitis B surface antigen - positive test. 9. Has known or history of functional or anatomic asplenia. 10. Has failure to thrive based on the clinical judgement of the investigator. 11. Has a bleeding disorder contraindicating intramuscular vaccination. 12. Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders). 13. Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders. 14. Has received a dose of any pneumococcal vaccine prior to study entry. 15. Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry. 16. Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenzae type b conjugate vaccine, poliovirus vaccine, rotavirus vaccine, or any combination thereof, prior to study entry. 17. *Meets one or more of the following systemic corticosteroid exclusion criteria: a. Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14 consecutive days and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization. b. Has received or is expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine. c. Is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study. Note: Topical, ophthalmic, and inhaled steroids are permitted. 18. *Has received other licensed non-live vaccines within 14 days before receipt of study vaccines or is scheduled to receive any licensed non-live vaccine within 30 days following receipt of study vaccines. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine s or at least 15 days after receipt of study vaccines. 19. *Has received a licensed live vaccine within 30 days before receipt of study vaccines or is scheduled to receive any live vaccine within 30 days following receipt of study vaccines. 20. Has received a blood transfusion or blood products, including immunoglobulins. 21. Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor. Other Exclusions 22. Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study. 23. Is or has an immediate family member (eg, parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.

Number of Visits

    » 6 In person visit(s)

    6 Clinic

    » 1 Remote visit(s)

    1Telephone Contact

Participation Period

16-20 months

Compensation

$75 per Clinic visit for travel expenses

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.