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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Page 1 of 3 (9 locations)

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