Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSerum Institute of India Pvt. Ltd.

About this trial

The primary purpose of this study is to test a new experimental recombinant Poliomyelitis vaccine (rPV) in comparison to the commercially available inactivated poliovirus vaccine. The design of the study is double-blinded, randomised and active controlled. The active controlled product is considered the commercially available vaccine (IPOL).

Eligibility criteria

Qualifiers

Healthy Volunteers aged between 18 to 60 years inclusive.

Good physical and mental health based on medical history, physical examination, clinical laboratory,electrocardiogram (ECG), and vital signs, as judged by the Investigator.

Participants must refrain from strenuous exercise within 96 hours (4 days) prior to Screening, Day 1, Day 8,and Day 30..

Willing and able to comply with restrictions of nicotine (i.e., tobacco and nicotine products) usethroughout the study is not permitted from within 48 hours (2 days) prior to Screening, from Day 1 until Day8, and within 48 hours (2 days) prior to the end of study visit.

Disqualifiers

History of Polio

Any vaccination received 30 days before Screening and Day 30

Pregnant or lactating females

BMI >35.0kg/m2

Trial design

Treatments tested in this trial

  • Recombinant Poliomyelitis Vaccine (rPV)
  • Inactivated Poliomyelitis Vaccine (IPOL)

Treatment groups

36 Participants
are divided into 2 treatment groups