A Phase IV multicentric, randomized, comparative clinical trial to assess the immunogenicity and Reactogenicity of two different lots of DTwP-HB+Hib (Pentavac) vaccine manufactured by Serum Institute Of India Ltd., Pune in Indian infants.

Serum Institute Of India Ltd0 个研究点目标入组 600 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Healthy children of either sex aged 6 to 8 weeks at the time of 1st vaccination.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Written, Explained, Signed informed consent of the child parents or guardian.
•Born after normal gestational period (36-42 weeks).
•Born to mothers sero-negative for HBs Ag (as per current antenatal records or test conducted after informed consent of mother).
•Born to mothers sero-negative for HIV (as per current antenatal records or test conducted after informed consent of mother).
•No evidence of any infection or fever.
•Available for an observation period of minimum 16 weeks.

•Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of the study vaccine.
•History of DTwPHB vaccine/Hib vaccination or disease (including Hepatitis B given at birth)
•Administration of immunoglobulins or any blood products since birth.
•Planned administration of a vaccine, not foreseen by the study protocol 30 days before and during the study period with the exception of OPV & BCG vaccine.
•History of significant and persistent hematological, hepatic, renal, cardiac or respiratory disease.
•Axillary temperature more than or equal to 38.5 degrees celsius.
•History of Neurological disorders or seizure.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Confirmed immunosuppression including HIV infection.
•Major congenital or hereditary immunodeficiency.
•Simultaneous participation in any other clinical study.

发起方

Serum Institute Of India Ltd