Biological E’s Polio vaccine clinical study for protection against Polio disease in 6-8 weeks old infants.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2023/08/055993
- Lead Sponsor
- Biological E.Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. Subjects’ parent(s)/ 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).
2. Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
3. A male or female healthy infant of either gender between 6-8 weeks of age at the time of 1st vaccination.
4. Healthy infants with body weight = 3300 gms at the time of 1st vaccination
5. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the principal investigator.
6. Subjects not participating in any other clinical trials.
7. Receipt of single birth dose of OPV (within 14 days of birth).
8. Infants without contraindications or precautionary circumstances for participating in the trial.
1.Prior immunization or intent to receive oral/injectable polio vaccine (OPV/IPV) within the study period with an exception of birth dose of oral polio vaccine.
2. Current illness (especially fever) or any acute or congenital illness or disability.
3. 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.
4.Subjects receiving immunosuppressive therapy
5.Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
6.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.
7. Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS)
8. Known family history of SIDS (Sudden Infant Death Syndrome).
9. Planned or elective surgery during the course of the study.
10. Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.
11. Subjects and / or their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
12. Inability or unwillingness of the parent to abide by the requirements of the protocol.
13. Family history of congenital or hereditary immunodeficiency.
14. Any criteria, which in the judgement of the Investigator, suggests that the subject would not be compliant with the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Seroprotection rates (SPR%) in each treatment arm, defined as proportion of subjects with anti-Polio antibodies against poliovirus serotype 1, poliovirus serotype 2 and poliovirus serotype 3. <br/ ><br>2. Anti-Polio IgG antibody titres against each vaccine serotype.Timepoint: 1. At 28 days’ post third dose of vaccination. <br/ ><br>2. At Day 28 post third dose of vaccination
- Secondary Outcome Measures
Name Time Method Proportion of subjects with solicited local adverse reactions and systemic adverse eventsTimepoint: During first 60 minutes of post vaccination observation period and for 7 consecutive days;Proportion of subjects with unsolicited local and systemic adverse events (AEs)Timepoint: during the total study period until 28 days’ post third dose of vaccination;Serious adverse events (SAEs), Medically attended adverse events and AEs of special interest (AESI), if anyTimepoint: during the total study period until 28 days’ post third dose of vaccination