NL-OMON49743
Completed
Phase 3
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)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pfizer
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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