A multicentric, single blind, parallel, randomized, phase-IV non-inferiority study to evaluate the immunogenicity & safety of BE?s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered to 6-8 week old healthy Indian infants at 6-10-14 weeks schedule in comparison with a marketed SIIL?s Pentavac SD? vaccine

Biological ELimited0 个研究点目标入组 408 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Healthy infants between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) of either gender at the time of 1st vaccination.
•Written informed consent obtained from the subjects parent(s) or legally acceptable representative / guardian.
•Healthy infants with weight equal to or more than 3300 gms at the time of screening.
•Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature).
•Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary.
•Infants or their mothers not participating in any other clinical trials.
•Infants without contraindications or precautionary circumstances for participating in the trial
•Ability of the infants parent or legally acceptable representative/guardian to understand and comply with the requirements of the protocol.

•Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral &/or Inactivated polio vaccine.
•Current illness (especially fever) or any acute or congenital illness or disability.
•Subjects receiving immunosuppressive therapy.
•Known or suspected allergy to any of the vaccine components.
•Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS).
•Known family history of SIDS (Sudden Infant Death Syndrome).
•Planned or elective surgery during the course of the study.
•Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.
•Subjects and their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
•Inability or unwillingness to abide by the requirements of the protocol.
•Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.

发起方

Biological ELimited