Assessing a new hexavalent vaccine for infants

An Observer-blind, Randomized, Active-controlled, Multi-centric Phase III Study to Assess Immunogenicity and Safety of Hexavalent (DTwP-Hepatitis B-IPV-Hib) Vaccine Containing Reduced Dose IPV in Comparison With HEXASIIL®

This study is testing a new, lower-dose vaccine for infants to see if it safely protects them against multiple diseases just as well as the regular vaccine.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1557 (estimated)
• Ages: 6 Weeks to 8 Weeks
• Sex: All
• Sponsor: Serum Institute of India Pvt. Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 9 sites (Dhaka and 8 other locations)
• Trial ID: NCT06413121 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the immunogenicity and safety of a reduced dose inactivated polio vaccine (IPV) hexavalent combination vaccine in healthy infants and toddlers. A total of 1,557 infants aged 6-8 weeks will be randomized to receive either the new reduced dose vaccine or a licensed hexavalent vaccine. The study will monitor safety and immune responses following a primary vaccination series and a booster dose, with follow-ups scheduled for safety assessments at various intervals. The goal is to enhance the affordability and accessibility of IPV while ensuring effective immunization against multiple diseases.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy infants aged 6-8 weeks who meet specific health criteria.

Not a fit: Patients with a history of infections related to the targeted diseases or those with acute illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more affordable and effective vaccination option for infants, improving public health outcomes.

How similar studies have performed: Other studies have shown promise in similar approaches to vaccine development, but this specific reduced dose IPV hexavalent vaccine is a novel approach.

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.

Where this trial is running

Dhaka and 8 other locations

• International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) — Dhaka, Bangladesh (Recruiting)
• Manipal Academy of Higher Education, Manipal — Mangalore, Karnataka, India (Recruiting)
• JSS Medical College and Hospital — Mysore, Karnataka, India (Recruiting)
• Bharati Vidyapeeth Medical College and Hospital, Pune — Pune, Maharashtra, India (Recruiting)
• KEM Hospital and Research Centre, Vadu — Pune, Maharashtra, India (Recruiting)
• 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 (Recruiting)
• Sri Ramachandra Medical Centre, Chennai — Chennai, Tamil Nadu, India (Recruiting)
• Institute of Child Health, Kolkata — Kolkata, West Bengal, India (Recruiting)
• Post Graduate Institute of Medical Education and Research (PGIMER) — Chandigarh, India (Recruiting)

Study contacts

• Principal investigator: Anand Kawade — KEM Hospital Research Centre, Pune, India
• Study coordinator: Hitt Sharma

Conditions Diptheria Immunization; Tetanus Immunization; Pertussis Immunization; Hepatitis B Immunization; Haemophilus Influenzae Type B Immunization; Polio Immunization