Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)

NCT07855172 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: SII-rPV-wHEXA-02
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I/II, double-blind, randomized, active controlled, multi-centric clinical trial to assess the reactogenicity, safety and immunogenicity of a SIIPL DTwP-HepB-rPV-Hib vaccine in comparison with HEXASIIL® in healthy toddlers and infants. This trial is planned as a Phase I/II trial with two age cohorts to be enrolled sequentially, starting with healthy toddlers and subsequently extending to healthy infants. In Phase I of the trial, after at least one parent signs the informed consent and the participant's eligibility is confirmed, healthy toddlers aged 12-24 months will be randomized in a 2:1 ratio, to receive 0.5 mL of either of the vaccines intramuscularly in the upper anterolateral aspect of the thigh. Following vaccination, all toddlers will be observed at the site for minimum 30 (+15) minutes for any Iimmediate Adverse Event (IAE). Solicited Adverse Events (AEs) will be actively collected for 7 days post vaccination. Unsolicited AEs and Serious AEs will be collected throughout the trial from the time of signing informed consent till 28 days post vaccination. Blood samples for immunogenicity assessment will be obtained from all participating toddlers at Visit 1 (Prior to vaccination) and at Visit 4. A Data Safety Monitoring Board (DSMB) meeting will be convened for the evaluation of 7-day safety data in all participants. The DSMB shall review the safety data and provide recommendations to initiate Phase II of the trial. Additionally, Safety Review Comitte (SRC) will review the 24-hour safety data from the initial sentinel group (three participants) and give advice on progression to the subsequent enrolment in Phase I. After at least one parent signs the informed consent and the participant's eligibility is confirmed, all infants will be randomized in 2:1 ratio to receive a 3-dose primary vaccination series at 6, 10 and 14 weeks of age. Each participant will receive 0.5 mL of either vaccine intramuscularly in the upper anterolateral aspect of the thigh. Following each vaccination, all infants will be observed at the site for minimum 30 (+15) minutes for any IAEs. Active follow up for solicited AEs will be conducted over the 7-day period after each vaccination. Unsolicited AE/SAEs will be collected from signing of informed consent till Visit 10. Blood samples for immunogenicity assessment will be obtained from all participating infants at Visit 1 (Prior to vaccination) and at Visit 10.

Conditions

Diptheria Immunization; Tetanus Immunization; Pertussis Immunization; Hepatitis B Immunization; Haemophilus InfluenzaeType B Immunization; Polio Immunization

Keywords

hexavalent; phase I

Outcome Measures

Primary Outcomes (2)

• The incidence, severity and relationship of solicited AEs occurring up to 7 days following vaccination, unsolicited AEs and Serious Adverse Events till 28 days following vaccination in toddlers

  28 days

• The incidence, severity and relationship of 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 in infants

  28 days post last dose

Secondary Outcomes (4)

• Percentage of toddlers achieving seroprotection for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b, poliovirus types 1, 2 & 3 and seroconversion/seropositivity for pertussis and, 28 days following vaccination

  28 days

• Percentage of infants achieving seroprotection for diphtheria, tetanus, hepatitis B, Hib, seroprotection and seroconversion for poliovirus types 1, 2 & 3 and seroconversion/seropositivity for pertussis and, 28 days post completion of 3 doses.

  28 days after last dose

• Geometric mean concentrations/titres (GMCs/GMTs) of anti-diphtheria, anti-tetanus, anti-pertussis, anti-HBsAg, anti-PRP (polyribosyl ribitol phosphate) and anti-polio types 1, 2 & 3 antibodies, 28 days following vaccination in toddlers

  28 days

• Geometric mean concentrations/titres (GMCs/GMTs) of anti-diphtheria, anti-tetanus, anti-pertussis, anti-HBsAg, anti-PRP and anti-polio types 1, 2 & 3 antibodies, 28 days post completion of a 3-dose primary vaccination series in infants.

  28 days after last dose

Study Arms (2)

Hexavalent (DTwP-HepB-rPV-Hib) Vaccine

EXPERIMENTAL

Hexavalent (DTwP-HepB-rPV-Hib) Vaccine for active immunization of infants and toddlers

Biological: Hexavalent (DTwP-HepB-rPV-Hib) Vaccine

HEXASIIL

ACTIVE COMPARATOR

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine for active immunization of infants and toddlers

Biological: HEXASIIL

Interventions

Hexavalent (DTwP-HepB-rPV-Hib) Vaccine BIOLOGICAL

Hexavalent (DTwP-HepB-rPV-Hib) Vaccine

Hexavalent (DTwP-HepB-rPV-Hib) Vaccine

HEXASIIL BIOLOGICAL

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine

HEXASIIL

Eligibility Criteria

• Age: 6 Weeks - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Phase 1
• Male or female toddlers aged between 12-24 (both inclusive) months on the day of vaccination, who have completed primary immunization series against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (Oral Polio Vaccine \[OPV\] and/or Inactivated Polio Vaccine \[IPV\]) and Haemophilus influenzae type b at least 6 months prior to enrolment and have not received the booster dose for the above-mentioned vaccines.
• Toddlers in good health, as determined by their medical history, physical examination and the clinical judgment of the Investigator.
• Toddlers with weight-for-length z-score is ≥ -2 Standard Deviation (SD) at the time of enrolment.
• Toddler's parent(s) willingness and ability to comply with the requirements of the protocol.
• Informed consent signed by at least one parent.
• Phase 2
• 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.
• Infants who are OPV naive.
• 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 SD at the time of enrolment.
• Willingness of participant's parent(s) to comply with the requirements of the protocol.

You may not qualify if:

• Phase 1
• History of diphtheria/tetanus/pertussis/hepatitis B/Haemophilus influenzae type b/poliomyelitis infection(s).
• Presence of fever ≥ 38°C/100.4°F within 48 hours.
• Acute illness of moderate to severe intensity according to the clinical judgment of the investigator.
• History of administration of any investigational or non-registered product (drug or vaccine) within 4 weeks prior to administration of IMPs or planned during the course of trial participation.
• Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the IMP administration or planned receipt of any vaccine during the trial participation period.
• History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of IMPs.
• History of following events that are known to have occurred in temporal relation to receipt of pertussis-containing vaccine:
• temperature ≥40°C within 48 hours of vaccination, not due to another identifiable cause.
• collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination.
• persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
• History of major congenital defects or developmental disorders or genetic diseases as determined by medical history or clinical assessment.
• History of thrombocytopenia or a bleeding disorder following IM administration.
• History or current evidence of any clinically significant chronic disease that in the opinion of the Investigator might interfere with the evaluation of trial objectives.
• Receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to IMP administration, or planned administration during the active trial period.

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead

Study Sites (1)

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

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

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 1
• 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: September 21, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

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

Locations

BA (1)