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Clinical Trials/EUCTR2019-003306-27-CZ
EUCTR2019-003306-27-CZActive, not recruitingPhase 1

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS

Pfizer Inc.0 sites1,200 target enrollmentStarted: May 27, 2020Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
1,200
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Age and Sex:
  • •1. Male or female infants born at >36 weeks of gestation and 2 months of age (=42 to =112 days) at the time of consent (the day of birth is considered day of life 1).
  • •Type of Participant and Disease Characteristics:
  • •2. Participants whose parent(s)/legal guardian(s) are willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
  • •3. Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
  • •4. Expected to be available for the duration of the study and whose parents(s)/legal guardian can be contacted by telephone during study participation.
  • •Informed Consent:
  • •5. Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 1200
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Medical Conditions:
  • •1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of investigational product or any diphtheria toxoid–containing vaccine.
  • •2. Significant neurological disorder or history of seizure including febrile seizure or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma, such as Erb’s palsy and/or hypotonic-hyporesponsive episodes.
  • •3. Major known congenital malformation or serious chronic disorder.
  • •4. History of microbiologically proven invasive disease caused by S pneumoniae.
  • •5. Known or suspected immunodeficiency or other conditions associated with immunosuppression, including, but not limited to, immunoglobulin class/subclass deficiencies, DiGeorge syndrome, generalized malignancy, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, or organ or bone marrow transplant.
  • •6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • •7. Congenital, functional, or surgical asplenia.
  • •8. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • •Prior/Concomitant Therapy:
  • •9. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
  • •10. Prior receipt of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine.
  • •11. Currently receives treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt through the last blood draw. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.
  • •12. Receipt of blood/plasma products or immunoglobulins (including hepatitis B immunoglobulin) since birth or planned receipt through the last planned blood draw in the study (Visit 5, 13-month visit).
  • •Prior/Concurrent Clinical Study Experience:
  • •13. Participation in other studies involving investigational drug(s), investigational vaccines, or investigational devices within 28 days prior to study entry and/or during study participation or intrauterine exposure to investigational vaccines. Participation in purely observational studies is acceptable.
  • •Diagnostic Assessments:
  • •Not applicable.
  • •Other Exclusions:
  • •14. Children or grandchildren who are direct descendants of investigator site staff members or Pfizer employees who are directly involved in the conduct of the study.

Investigators

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