Last updated on November 2019

A Study to Assess the Safety Reactogenicity and Immunogenicity of a Trivalent Inactivated Poliovirus Vaccine (IPV) Based on Sabin Strains Compared to Conventional Salk IPV in a 6 10 and 14 Weeks of Age Immunization Schedule

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: healthy
  • Age: Between 1 - 1 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Study participant is a boy or a girl, who is eligible for expanded programme on immunization (EPI) vaccinations (that is, inactivated poliovirus vaccine [IPV], Diphtheria, Tetanus, whole cell Pertussis [DTwP]-Haemophilus influenzae type b [Hib]-Hepatitis B virus [HBV] and 13-valent Pneumococcal conjugate vaccine [PCV13]) at Weeks 6, 10 and 14 and Rotavirus vaccination at Weeks 6 and 14
  • Study participant has born after a normal term pregnancy (greater than or equal to [>=]37 weeks) and with a birth weight of >=2.5 kilogram (kg)
  • Study participant must be healthy as confirmed by the investigator on the basis of physical examination, vital signs and medical history, including the course of the pregnancy and relevant medical history of the mother, such as but not limited to human immunodeficiency virus, Hepatitis B virus (HBV), hepatitis C virus status or other significant disease that might impact the participant's health. Information about the course of the pregnancy and relevant medical history of the mother is obtained from the mother in person and at the discretion of the investigator without the need for official documentation or testing
  • Each study participant and his or her legally acceptable representative must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Study participant and his or her legally acceptable representative are available and reachable for all scheduled study visits and telephone contacts within the allowed window

Exclusion Criteria:

  • Contraindication to intramuscular (IM) injections and blood draws (venipuncture) for example, bleeding disorders
  • Known allergies, hypersensitivity, or intolerance to 1 of the excipients of IPV based on Sabin strains (sIPV) or conventional Salk IPV (cIPV) or any other vaccine component in the participant or mother
  • Received polio vaccine or were previously infected with poliovirus
  • Known or suspected autoimmune disease or persistent impairment/alteration of the immune function
  • Known neurological disease including seizures, congenital defects, or genetic disorders (for example, Down syndrome)

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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