Polio Immunity
Conditions
Keywords
recombinant, polio
Brief summary
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).
Detailed description
This study is a double-blinded, randomised, active controlled, Phase 1 clinical study, to determine the safety, tolerability, and reactogenicity of Serum Institute of India Pvt Ltd (SIIPL) rPV vaccine in comparison to the commercially available inactivated poliovirus vaccine (IPOL®, Sanofi) in up to 36 healthy adults aged between 18 and 60 years. This study will be conducted at a single study site in Australia. Participants will be randomised in a 2:1 ratio, to receive either investigational vaccine (rPV) or comparator vaccine (IPOL), respectively. The study vaccine will be administered as a single intramuscular (IM) injection into the deltoid muscle of the non-dominant upper arm. The participants will be followed for 30 days post vaccination.
Interventions
BIOLOGICALRecombinant Poliomyelitis Vaccine (rPV)
Recombinant Poliomyelitis Vaccine (VLP) is manufactured by Serum Institute of India Pvt. Ltd.
BIOLOGICALInactivated Poliomyelitis Vaccine (IPOL)
IPOL (inactivated poliovirus vaccine) is a marketed Sanofi
Sponsors
Serum Institute of India Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
immunogenicity laboratory
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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. * Participants must agree to use highly effective contraception from Day 1 until 90 days after the last studyvisit. Key
Exclusion criteria
* History of Polio * Any vaccination received 30 days before Screening and Day 30 * Pregnant or lactating females * BMI \>35.0kg/m2 * History of alcohol abuse or drug addiction * Have received any polio vaccines within 6 months prior to screening. * History of major surgeries * History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior tostudy vaccination * any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence, severity and relationship of solicited adverse events (AEs) during 7-day and unsolicited AEs during 30-day follow-up period after rPV and IPOL vaccination | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving seroprotection/seroconversion for poliovirus Types 1, 2 and 3, on Day 30. | 30 days |
Countries
Australia
Contacts
CONTACTDr Hitt Sharma, MBBS MBA
CONTACTDr Sameer Parekh, MBA
STUDY_DIRECTORDr Hitt Sharma, MBBS MBA
Serum Institute of India Pvt. Ltd.
Outcome results
None listed