NL-OMON49743已完成3 期
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 - 9002/0612 (B7471012)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •Section 5.1 in protocol
- •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).
- •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.
- •5. Participants whose parent(s)/legal guardian(s) is capable of giving signed
- •informed consent as described in Appendix 1, which includes compliance with the
- •requirements and restrictions listed in the ICD and in this protocol.
排除标准
- •Section 5.2 in protocol
- •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 pneumonia
- •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
- •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.
- •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
- •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).
- •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.
- •14. Children or grandchildren who are direct descendants of investigator site
- •staff members or Pfizer employees who are directly involved in the conduct of
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