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Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV
Led by Serum Institute of India Pvt. Ltd. · Updated on 2024-09-19
1557
Participants Needed
9
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 cases of polio by replacing the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent OPV that lacks the type 2 Sabin virus. Since the WHA resolution, all countries that were solely using OPV have either introduced Inactivated Polio Vaccine (IPV) into their routine immunization schedule or decided to introduce IPV but have been unable to secure supply. The global demand for IPV has therefore substantially increased in just a few years. Many initiatives are ongoing to meet the increasing demand for IPV. One potential approach is the reduction of the amount of antigen per vaccine dose. Therefore, to enhance the affordability, effectiveness and accessibility of IPV. SIIPL has manufactured hexavalent combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and a reduced dose of three IPV antigens. Based on available published data, reduction of the antigen content of each of the three poliovirus types in IPV is feasible, without substantially compromising the immunogenicity of the vaccine. Advantages of a reduction in antigen content are two-fold: increased availability of IPV and reduced cost, both of major importance for the global eradication programme.
CONDITIONS
Official Title
Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female infants aged 6-8 weeks at first vaccination
- Good health confirmed by medical history and examination
- Signed informed consent from at least one parent
- Born at full term (37 or more weeks gestation)
- Weight-for-length z-score of -2 SD or higher at enrollment
- Parent willing to follow study protocol requirements
You will not qualify if you...
- History of infections with diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, or poliomyelitis
- Fever of 38°C (100.4°F) or higher
- Moderate to severe acute illness
- Antibiotic use in the past 3 days
- Previous or planned receipt of vaccines against study diseases (except certain birth doses and trial vaccines)
- Vaccine received in the 4 weeks before first trial vaccination (except government OPV campaign)
- Major congenital defects or illnesses requiring medical therapy
- Clinically significant chronic diseases affecting study evaluation
- History of anaphylaxis or serious vaccine reactions
- Known or suspected immune impairment or immunosuppressive therapy
- Neurological disorders, seizures, or encephalopathy
- Known bleeding disorders
- Personal or maternal history of HIV, Hepatitis B, or Hepatitis C
- Planned surgery during the study
- Receipt or planned receipt of blood products or immunoglobulins interfering with immune assessment
- Participation in another clinical trial within 4 weeks before enrollment or planned during this trial
- Plans to move away from study area before study completion
AI-Screening
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Trial Site Locations
Total: 9 locations
1
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)
Dhaka, Bangladesh, 128
Actively Recruiting
2
Manipal Academy of Higher Education, Manipal
Mangalore, Karnataka, India, 576104
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3
JSS Medical College and Hospital
Mysore, Karnataka, India, 570004
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4
Bharati Vidyapeeth Medical College and Hospital, Pune
Pune, Maharashtra, India, 411043
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5
KEM Hospital and Research Centre, Vadu
Pune, Maharashtra, India, 412216
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6
Hamdard Institute of Medical Sciences and Research (HIMSR) with Centre for health research & Development, Society for applied studies, Hakeem Abdul Hameed Centenary Hospital (HAHCH)
New Delhi, National Capital Territory of Delhi, India, 110062
Actively Recruiting
7
Sri Ramachandra Medical Centre, Chennai
Chennai, Tamil Nadu, India, 600116
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8
Institute of Child Health, Kolkata
Kolkata, West Bengal, India, 700017
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9
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India, 160012
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Research Team
H
Hitt Sharma
CONTACT
S
Sameer Parekh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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