Status:
RECRUITING
Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV
Lead Sponsor:
Serum Institute of India Pvt. Ltd.
Conditions:
Diptheria Immunization
Tetanus Immunization
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief Summary
In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived c...
Detailed Description
This is an observer-blind, randomized, active-controlled, multi-centric study in healthy infants and toddlers to assess the immunogenicity and safety of SIIPL reduced IPV hexavalent vaccine in compari...
Eligibility Criteria
Inclusion Criteria:
- Male or female infants aged 6-8 weeks at the time of first vaccination.
- Infants with good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
- Informed consent form signed by at least one parent.
- Infants born at full term pregnancy (≥ 37 weeks).
- Infants with weight-for-length z-score ≥ -2 standard deviation (SD) at the time of enrolment.
- Willingness of subjects' parent to comply with the requirements of the protocol.
Exclusion Criteria:
- History of diphtheria/ tetanus/ pertussis/ hepatitis B/ Haemophilus Influenzae type b/ poliomyelitis infection(s).
- Presence of fever ≥ 38°C/ 100.4°F.
- Acute illness of moderate to severe intensity according to the clinical judgment of the investigator .
- Receipt of antibiotics in the past 3 days
- Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except birth dose), poliomyelitis (except OPV birth dose) or Haemophilus Influenzae type b infection apart from trial vaccines during the study period.
- Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the first trial vaccination.
- History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
- History of any clinically significant chronic disease that in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of study vaccine.
- Infants with known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy or received immunosuppressive therapy prior to study entry
- Presence of evolving or changing neurological disorder or infant with a history of seizures and/or encephalopathy.
- Known thrombocytopenia or a bleeding disorder.
- Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity.
- Planned surgery during the study.
- Receipt of blood or blood-derived products or immunoglobulins or planned administration during the trial which might interfere with the assessment of the immune response.
- Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
- Infants whose families are planning to leave the area of the study site before the end of the study period.
Key Trial Info
Start Date :
May 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
1557 Patients enrolled
Trial Details
Trial ID
NCT06413121
Start Date
May 6 2024
End Date
May 31 2026
Last Update
September 19 2024
Active Locations (9)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)
Dhaka, Bangladesh, 128
2
Manipal Academy of Higher Education, Manipal
Mangalore, Karnataka, India, 576104
3
JSS Medical College and Hospital
Mysore, Karnataka, India, 570004
4
Bharati Vidyapeeth Medical College and Hospital, Pune
Pune, Maharashtra, India, 411043