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)

A Phase I/II, Double-Blind, Randomized, Active Controlled, Multi-centric Clinical Trial to Assess the Reactogenicity, 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) in Comparison With HEXASIIL® (DTwP-HepB-IPV-Hib) Vaccine in Healthy Toddlers and Infants.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis B Immunization; Diptheria Immunization; Tetanus Immunization; Pertussis Immunization; Polio Immunization; Haemophilus InfluenzaeType B Immunization
• Intervention / Treatment: Biological: Hexavalent (DTwP-HepB-rPV-Hib) Vaccine; Biological: HEXASIIL

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hitt Sharma; Phone Number: +912026602451; Email: drhjs@seruminstitute.com
• Study Contact Backup: Name: Sameer Parekh; Phone Number: +912026602139; Email: sameer.parekh@seruminstitute.com

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1212
    • International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
    • Contact: K. Zaman; Phone Number: +880-1713047100; Email: kzaman@icddrb.org
    • Principal Investigator: K. Zaman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Phase 1

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.
2. Toddlers in good health, as determined by their medical history, physical examination and the clinical judgment of the Investigator.
3. Toddlers with weight-for-length z-score is ≥ -2 Standard Deviation (SD) at the time of enrolment.
4. Toddler's parent(s) willingness and ability to comply with the requirements of the protocol.
5. Informed consent signed by at least one parent.

Phase 2

1. Male or female infants aged 6-8 weeks at the time of first vaccination.
2. Infants with good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
3. Infants who are OPV naive.
4. Informed consent form signed by at least one parent.
5. Infants born at full term pregnancy (≥ 37 weeks).
6. Infants with weight-for-length z-score ≥ -2 SD at the time of enrolment.
7. Willingness of participant's parent(s) to comply with the requirements of the protocol.

Exclusion Criteria:

Phase 1

1. History of diphtheria/tetanus/pertussis/hepatitis B/Haemophilus influenzae type b/poliomyelitis infection(s).

2. Presence of fever ≥ 38°C/100.4°F within 48 hours.

3. Acute illness of moderate to severe intensity according to the clinical judgment of the investigator.

4. 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.

5. 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.

6. History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of IMPs.

7. 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.

8. History of major congenital defects or developmental disorders or genetic diseases as determined by medical history or clinical assessment.

9. History of thrombocytopenia or a bleeding disorder following IM administration.

10. 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.

11. 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.

12. Receipt of antibiotics in the past 3 days.

13. Family history of any medical conditions, that in the investigator's opinion, could affect the trial outcomes.

14. Presence of evolving or changing neurological disorder or toddler with a history of seizures and/or encephalopathy.

15. Known personal or maternal history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C seropositivity.

16. Planned surgery during the trial.

17. Toddlers with a 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 within 3 months prior to entry in the trial.

18. Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.

19. Toddlers whose families are planning to leave the area of the trial site before the end of the trial period.

Phase 2

1. History of diphtheria/tetanus/pertussis/hepatitis B/Haemophilus influenzae type b/poliomyelitis infection(s).
2. Presence of fever ≥ 38°C/100.4°F within 48 hours.
3. Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except birth dose), poliomyelitis or Haemophilus influenzae type b infection apart from IMPs during the trial period.
4. Acute illness of moderate to severe intensity according to the clinical judgment of the investigator.
5. Administration of any vaccine in the 4 weeks (except BCG) preceding the first dose of IMP administration.
6. Receipt of antibiotics in the past 3 days.
7. History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
8. History of any clinically significant chronic disease that in the opinion of the Investigator, might interfere with the evaluation of the trial objectives.
9. History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of IMP.
10. Infants with a 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 trial entry.
11. Presence of evolving or changing neurological disorder or infant with a history of seizures and/or encephalopathy.
12. Known thrombocytopenia or a bleeding disorder.
13. Planned surgery during the trial.
14. Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity.
15. 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.
16. Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
17. Infants whose families are planning to leave the area of the trial site before the end of the trial period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hexavalent (DTwP-HepB-rPV-Hib) Vaccine; Hexavalent (DTwP-HepB-rPV-Hib) Vaccine for active immunization of infants and toddlers	Biological: Hexavalent (DTwP-HepB-rPV-Hib) Vaccine; Hexavalent (DTwP-HepB-rPV-Hib) Vaccine
Active Comparator: HEXASIIL; Hexavalent (DTwP-HepB-IPV-Hib) Vaccine for active immunization of infants and toddlers	Biological: HEXASIIL; Hexavalent (DTwP-HepB-IPV-Hib) Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Serum Institute of India Pvt. Ltd.
• Investigators: Study Director: Hitt Sharma, Serum Institute of India Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 21, 2026
• First Submitted That Met QC Criteria: September 29, 2026
• First Posted (Actual): October 2, 2026

Study Record Updates

• Last Update Posted (Actual): October 6, 2026
• Last Update Submitted That Met QC Criteria: October 5, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: phase I; hexavalent
• Additional Relevant MeSH Terms: Biological Products; Complex Mixtures; Vaccines
• Other Study ID Numbers: SII-rPV-wHEXA-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Summary results

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No