Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
70-111 years
Phase:
PHASE3
Brief Summary
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one o...
Eligibility Criteria
Inclusion
- Is male or female, approximately 3 months of age, from 70 days to 111 days inclusive, at the time of signing the informed consent.
- 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.
Exclusion
- Was born prior to 37 weeks of gestation.
- Has a history of invasive pneumococcal disease (IPD) or known history of other culture positive pneumococcal disease.
- Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid containing vaccine.
- Has any contraindication to the concomitant study vaccines being administered in the study.
- Has a known or suspected impairment of immunological function.
- Has a history of congenital or acquired immunodeficiency.
- Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection.
- Has, or his/her mother has, a documented hepatitis B surface antigen - positive test.
- Has known or history of functional or anatomic asplenia.
- Has failure to thrive based on the clinical judgement of the investigator.
- Has a bleeding disorder contraindicating intramuscular vaccination.
- 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).
- Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
- Has received a dose of any pneumococcal vaccine prior to study entry.
- Has received \>1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry.
- Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenza type b conjugate vaccine, poliovirus vaccine, or any other combination thereof, prior to study entry.
- Has received a blood transfusion or blood products, including immunoglobulins.
- 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.
- 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.
- Is or has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.
Key Trial Info
Start Date :
August 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2021
Estimated Enrollment :
1191 Patients enrolled
Trial Details
Trial ID
NCT04016714
Start Date
August 28 2019
End Date
October 29 2021
Last Update
May 6 2023
Active Locations (24)
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1
Hvidovre Hospital ( Site 0003)
Hvidovre, Capital Region, Denmark, 2650
2
Aarhus Universitetshosp. Skejby ( Site 0002)
Aarhus, Central Jutland, Denmark, 8200
3
Regionshospitalet Herning Hospitalsenheden Vest ( Site 0006)
Herning, Central Jutland, Denmark, 7400
4
Aalborg Universitetshospital ( Site 0005)
Aalborg, North Denmark, Denmark, 9000