Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV

NCT06413121 | Recruiting Phase 3 DMC

• 1 other identifier: SII-wHEXA/IN-03
• Study Type: interventional
• Target: 1,557
• Locations: 2 countries
• Sites: 9

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 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

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

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of SIIPL reduced IPV hexavalent vaccine in comparison with SIIPL HEXASIIL® vaccine.

  Percentage of infants achieving seroprotection for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b, poliovirus types 1, 2 \& 3, seroresponse for anti-B. pertussis and seroconversion for anti-pertussis toxin, 28 days post completion of a 3-dose primary vaccination series.

  28 days post completion of 3-dose primary vaccination series in infants.

Secondary Outcomes (2)

• Assessment of occurrence, severity, and relationship of adverse events (AEs)

  Local and systemic solicited AEs occurring up to 7 days following each vaccination, unsolicited AEs and SAEs till 28 days post completion of a 3-dose primary vaccination series.

• Assessment of immunogenicity of SIIPL reduced IPV hexavalent vaccine with the comparator vaccine, SIIPL HEXASIIL® and to assess lot-to-lot consistency among 3 lots of SIIPL reduced IPV Hexavalent vaccine

  28 days post completion of the 3-dose primary vaccination series in infants.

Other Outcomes (2)

• Pre- and post-booster safety of SIIPL reduced IPV hexavalent vaccine and comparator vaccine, SIIPL HEXASIIL® in toddlers.

  Safety assessment from 28 days post completion of the 3-dose primary schedule till 28 days post booster.

• Pre- and post-booster immunogenicity of SIIPL reduced IPV hexavalent vaccine and comparator vaccine, SIIPL HEXASIIL® in toddlers.

  Immunogenicity at prebooster and 28 days post booster dose between 12-24 months of age.

Study Arms (2)

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV

EXPERIMENTAL

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV for active immunization of infants, as a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.

Biological: Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV

ACTIVE COMPARATOR

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV for active immunization of infants, as a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.

Biological: Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV

Interventions

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV BIOLOGICAL

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV BIOLOGICAL

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead

Study Sites (9)

International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)

Dhaka, 128, Bangladesh

RECRUITING

Manipal Academy of Higher Education, Manipal

Mangalore, Karnataka, 576104, India

RECRUITING

JSS Medical College and Hospital

Mysore, Karnataka, 570004, India

RECRUITING

Bharati Vidyapeeth Medical College and Hospital, Pune

Pune, Maharashtra, 411043, India

RECRUITING

KEM Hospital and Research Centre, Vadu

Pune, Maharashtra, 412216, 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, 110062, India

RECRUITING

Sri Ramachandra Medical Centre, Chennai

Chennai, Tamil Nadu, 600116, India

RECRUITING

Institute of Child Health, Kolkata

Kolkata, West Bengal, 700017, India

RECRUITING

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, 160012, India

RECRUITING

Study Officials

• Anand Kawade

  KEM Hospital Research Centre, Pune, India

  PRINCIPAL INVESTIGATOR

• Sonali Palkar

  Bharati Vidyapeeth Medical College Hospital and Research Centre, Pune, India

  PRINCIPAL INVESTIGATOR

• M D Ravi

  JSS Hospitla, Mysore, India

  PRINCIPAL INVESTIGATOR

• Veena Kamat

  Manipal Academy of Higher Education, Kasturba Medical College, Udipi and Karkala,India

  PRINCIPAL INVESTIGATOR

• P Umapathy

  Sri Ramchndra Institute of Higher Education and Research, Chennai, India

  PRINCIPAL INVESTIGATOR

• Kheya Ghosh

  Institute of Child Health, Kolkata, India

  PRINCIPAL INVESTIGATOR

• Madhu Gupta

  Post Graduate Institute of Medical Education and Research, Chandigarh, India

  PRINCIPAL INVESTIGATOR

• Afreen khan

  Hamdard Institute of Medical Sciences and Research (HIMSR), New Delhi, India

  PRINCIPAL INVESTIGATOR

• Deepali Ambike

  Yashwantrao Chavan Memorial Hospital, Pimpri, Pune, India

  PRINCIPAL INVESTIGATOR

• K Zaman

  International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hitt Sharma

CONTACT

+912026602451; drhjs@seruminstitute.com

Sameer Parekh

CONTACT

+912026602139; sameer.parekh@seruminstitute.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 14, 2024
• Study Start: May 6, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after the study completion
• Access Criteria: Researchers who provide a methodologically sound proposal may be provided the access afterSponsor permission and if signed data-access agreements are in place.

Locations

BA (1); IN (8)