CTRI/2025/05/086953
Active, not recruiting
Phase 3
A single blind, randomized, active-controlled, phase-III study to evaluate immunogenicity and safety of Biological E’s inactivated poliomyelitis vaccine, administered to 6-8 weeks old healthy infants in 6-10-14 weeks dosing schedule.
Biological ELimited42 sites in 1 country3,875 target enrollmentStarted: May 26, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Biological ELimited
- Enrollment
- 3,875
- Locations
- 42
- Primary Endpoint
- To evaluate the proportion of subjects seroprotected with serotype specific anti-Polio antibodies among those vaccinated with either BE’s IPV or licensed comparator vaccine
Overview
Brief Summary
This is a prospective, single blind, randomized, active-controlled, phase-III study to evaluate immunogenicity and safety of Biological E’s inactivated poliomyelitis vaccine, administered to 6-8 weeks old healthy infants in 6-10-14 weeks dosing schedule.
The target population for this study would be 6-8 weeks old healthy infants of either gender, at the time of first dose administration. The total sample size to be enrolled would be 3875 healthy eligible subjects wherein N=3175 to be enrolled under BE’s IPV and N=700 under licensed comparator.
The study will be conducted in compliance with New Drugs and Clinical Trials Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 42.00 Day(s) to 56.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects’ parent(s) or LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential land line or mobile).
- •Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s) or LAR(s) of the subject prior to performing any study specific procedure.
- •A male or female healthy infant of either gender between 6-8 weeks 42-56 days, both inclusive of age at the time of first vaccination.
- •Healthy infants with body weight 3300 gms at the time of first vaccination.
- •Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the principal investigator.
- •Subjects not participating in any other clinical trials.
- •Infants with a minimal vaccination status for their age at the time of enrolment (Receipt of single birth dose of BCG, OPV and HBV vaccines (within 14 days of birth)).
- •Infants without contraindications or precautionary circumstances for participating in the trial.
Exclusion Criteria
- •1.Child in care
- •Prior immunization or intent to receive oralinjectable polio vaccine OPV or IPV within the study period with an exception of birth dose of oral polio vaccine.
- •Current illness (especially fever) or any acute or congenital illness or disability.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period.
- •Subjects receiving immunosuppressive therapy
- •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- •Known or suspected allergy to any of the vaccine components.
- •History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines.
- •Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS)
- •Known family history of SIDS (Sudden Infant Death Syndrome).
Outcomes
Primary Outcomes
To evaluate the proportion of subjects seroprotected with serotype specific anti-Polio antibodies among those vaccinated with either BE’s IPV or licensed comparator vaccine
Time Frame: At Day 84 (28 days’ post third dose).
Secondary Outcomes
- Proportion of subjects with solicited local adverse reactions and systemic events(during first 30 minutes of vaccine administration after each dose)
- Proportion of subjects with solicited local and systemic adverse events(during 7-day post vaccination period)
- Proportion of subjects with unsolicited adverse events (AEs) during the subsequent follow up period(28 days after each dose.)
- Proportion of subjects seroconverted with anti-Polio antibodies(at Day 84 (28 days’ post third dose).)
- Rate of serious adverse events (SAEs) and medically attended AEs(for the total study period.)
- GMTs for serotype specific anti-Polio neutralizing antibody titres estimated(both at baseline and again at Day 84)
- Proportion of subjects achieving 2-fold and 4-fold rise in serotype specific anti-Polio neutralizing antibody titres(at Day 84 from baseline.)
- GMFR for serotype specific anti-Polio neutralizing antibody titres(at Day 84 from baseline.)
- Number and proportion of subjects seroprotected with anti-Polio neutralizing antibodies(at Day 84 from baseline in three lots of BE’s IPV.)
- Number and proportion of subjects seroconverted with anti-Polio neutralizing antibodies(at Day 84 from baseline in three lots of BE’s IPV.)
- Proportion of subjects with SAEs(during the 6 months follow up period after the third dose of the vaccination)
- Number and proportion of subjects seroconverted, in terms of serum IgG concentrations induced by 14 serotypes(at Day 84 from baseline.)
- Number and proportion of subjects seroconverted or seroprotected (IgG concentrations) against Pentavalent DTwP-rHepB-Hib vaccine(at Day 84 from baseline.)
Investigators
Dr Subhash Thuluva
Biological E.Limited
Study Sites (42)
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