A phase 3, randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healhy Infants Given With Routine Pediatric Vaccination in Italy - ND

Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点开始时间: 2006年11月10日最近更新: 2012年3月19日

试验速览

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•1. Aged 3 months 75 to 105 days at time of enrollment. 2. Available for entire study period and whose parents/legal guardian can be reached by telephone. 3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. 4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight all subjects must meet inclusion criterion number 3. 5. Parent/legal guardian must be able to complete all relevant study procedures during subject participation.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•1. Previous vaccination with licensed or investigational pneumococcal vaccine. 2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines. 3. A previous anaphylactic reaction to any vaccine or vaccine-related component. 4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines. 5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 6. Known or suspected immune deficiency or suppression. 7. History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b. 8. Major known congenital malformation or serious chronic disorder. 9. 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 palsy. 10. Receipt of blood products or gamma-globulin including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis 61650; . 11. Participation in another investigational trial. Participation in purely observational studies is acceptable. 12. Infant who is a direct descendant child, grandchild of the study site personnel.

发起方

Wyeth Research Division of Wyeth Pharmaceuticals Inc.