A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of ProQuad™ Vaccine When Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers.

ovartis Vaccines and Diagnostics Inc.0 个研究点目标入组 1,830 人开始时间: 2014年11月17日最近更新: 2014年11月24日

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•Individuals eligible for enrollment in this study were those:
•Group I and II only:
•? who were 7 to 9 months old (inclusive) and for whom, after the nature of the study
•was explained, the parent or legal guardian provided written informed consent;
•Group III only:
•? who were 12 months old (inclusive, plus 14 days) and for whom, after the nature of
•the study was explained, the parent or legal guardian provided written informed
•All groups:
•? who received complete primary vaccination with recommended licensed vaccines;
•vaccination with Rotateq™ was not required for study entry
•? who were available for all visits and telephone calls scheduled for the study;
•? who were in good health as determined by:
•- medical history
•- physical assessment
•- clinical judgment of the investigator
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1830
•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

•Individuals not eligible to be enrolled in the study were those:
•? whose parent or legal guardian was unwilling or unable to give written informed
•consent to participate in the study or who was unwilling or unable to give written
•informed assent to participate in the study;
•? whose parent or legal guardian was perceived to be unreliable or unavailable for the
•duration of the study period;
•? who had a previous or suspected disease caused by N. meningitidis;
•? who had previous or suspected infection with measles, mumps, rubella, varicella,
•and/or herpes zoster;
•? who had household contact with and/or intimate exposure to an individual with
•culture-proven N. meningitidis infection within 60 days prior to enrollment;
•? who had household contact with and/or intimate exposure to an individual with
•measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment.

发起方

ovartis Vaccines and Diagnostics Inc.