## Protocol Section
### Identification Module
**NCT ID:** NCT06413121

**Brief Title:** Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV

**Official Title:** 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®

#### Organization Study ID Info
**ID:** SII-wHEXA/IN-03
#### Organization
**Class:** INDUSTRY
**Full Name:** Serum Institute of India Pvt. Ltd.
### Status Module
#### Completion Date
**Date:** 2026-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-06

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Serum Institute of India Pvt. Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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 comparison with the licensed SIIPL HEXASIIL® vaccine.

One thousand five hundred and fifty-seven infants aged 6-8 weeks (42 to 56 days, both days inclusive) will be randomized in a 2:1 ratio (1038 infants in SIIPL reduced IPV hexavalent group and 519 in SIIPL HEXASIIL® group), to receive a 3-dose primary vaccination series followed by their booster doses, respectively. The safety and immunogenicity data collected up to 28 days following third vaccination i.e., Visit 7, shall be submitted to the regulatory authority. All subjects will be followed up further for booster dose. After Visit 7 (i.e., 28 days following completion of primary vaccination series) subjects will be followed up for safety every 3 months starting from the age of 6 months (i.e., at 6, 9, 12, 15, 18, and 21 months of age) until they receive the booster dose anytime between 12-24 months. There will be post booster follow up visit (EOS visit) 28 days after the booster immunization i.e., Visit 10 to assess the safety and post booster immunogenicity.

### Conditions Module

**Conditions:**

- Diptheria Immunization

- Tetanus Immunization

- Pertussis Immunization

- Hepatitis B Immunization

- Haemophilus Influenzae Type B Immunization

- Polio Immunization

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1557

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

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

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

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

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

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

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

**Description:** 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.

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

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

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

**Description:** 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.

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

**Type:** BIOLOGICAL

### Outcomes Module

#### Other Outcomes

**Description:** Local and systemic solicited AEs occurring up to 7 days and unsolicited AEs and SAEs till 28 days post completion of booster vaccination.

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

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

**Description:** GMTs/ GMCs and Percentage of toddlers achieving seroprotection/seroconversion for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b, poliovirus types 1, 2 \& 3 and pertussis, prior to booster dose and 28 days after a booster dose.

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

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

#### Primary Outcomes

**Description:** 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.

**Measure:** Non-inferiority of SIIPL reduced IPV hexavalent vaccine in comparison with SIIPL HEXASIIL® vaccine.

**Time Frame:** 28 days post completion of 3-dose primary vaccination series in infants.

#### Secondary Outcomes

**Description:** local and systemic solicited AEs, unsolicited AEs and serious adverse events (SAEs)

**Measure:** Assessment of occurrence, severity, and relationship of adverse events (AEs)

**Time Frame:** 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.

**Description:** Geometric mean concentrations/ Geometric mean titres (GMCs/GMTs) for anti diphtheria, anti-tetanus, anti-B. pertussis, anti-pertussis toxin, anti-HBsAg, anti- polyribosylribitol phosphate (PRP) and anti-polio types 1, 2 \& 3 antibodies, 28 days post completion of the 3 dose primary vaccination series in infants.

**Measure:** 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

**Time Frame:** 28 days post completion of the 3-dose primary vaccination series in infants.

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 8 Weeks

**Minimum Age:** 6 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drhjs@seruminstitute.com

**Name:** Hitt Sharma

**Phone:** +912026602451

**Role:** CONTACT

**Contact 2:**

**Email:** sameer.parekh@seruminstitute.com

**Name:** Sameer Parekh

**Phone:** +912026602139

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Dhaka

**Contacts:**

***Contact 1:***

- **Email:** kzaman@icddrb.org

- **Name:** K Zaman, MD

- **Phone:** +880-1713047100

- **Role:** CONTACT

**Country:** Bangladesh

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

**Status:** NOT_YET_RECRUITING

**Zip:** 128

**Location 2:**

**City:** New Delhi

**Contacts:**

***Contact 1:***

- **Email:** drafreen.himsr@gmail.com

- **Name:** Afreen Khan

- **Phone:** +91-7503857784

- **Role:** CONTACT

**Country:** India

**Facility:** Hamdard Institute of Medical Sciences and Research (HIMSR) with Centre for health research & Development, Society for applied studies, Hakeem Abdul Hameed Centenary Hospital (HAHCH)

**State:** Delhi

**Status:** RECRUITING

**Zip:** 110062

**Location 3:**

**City:** Mangalore

**Contacts:**

***Contact 1:***

- **Email:** veenak@manipal.edu

- **Name:** Dr Veena Kamath

- **Role:** CONTACT

**Country:** India

**Facility:** Manipal Academy of Higher Education, Manipal

**State:** Karnataka

**Status:** RECRUITING

**Zip:** 576104

**Location 4:**

**City:** Mysore

**Contacts:**

***Contact 1:***

- **Email:** ravimdped@gmail.com

- **Name:** Ravi M D

- **Phone:** +91-9880629506

- **Role:** CONTACT

**Country:** India

**Facility:** JSS Medical College and Hospital

**State:** Karnataka

**Status:** NOT_YET_RECRUITING

**Zip:** 570004

**Location 5:**

**City:** Pune

**Contacts:**

***Contact 1:***

- **Email:** sonali.palkar@bharatividyapeeth.edu

- **Name:** Dr Sonali Palkar, M. D.

- **Phone:** +91-9881008717

- **Role:** CONTACT

**Country:** India

**Facility:** Bharati Vidyapeeth Medical College and Hospital, Pune

**State:** Maharashtra

**Status:** RECRUITING

**Zip:** 411043

**Location 6:**

**City:** Pune

**Contacts:**

***Contact 1:***

- **Email:** anand.kawade@kemhrcvadu.org

- **Name:** Dr. Anand Kawade

- **Phone:** +91-9850559983

- **Role:** CONTACT

**Country:** India

**Facility:** KEM Hospital and Research Centre, Vadu

**State:** Maharashtra

**Status:** RECRUITING

**Zip:** 412216

**Location 7:**

**City:** Chennai

**Contacts:**

***Contact 1:***

- **Email:** umapathy.p@sriramachandra.edu.in

- **Name:** Dr Umapathy P, M. D.

- **Phone:** +91-9841663959

- **Role:** CONTACT

**Country:** India

**Facility:** Sri Ramachandra Medical Centre, Chennai

**State:** Tamil Nadu

**Status:** RECRUITING

**Zip:** 600116

**Location 8:**

**City:** Kolkata

**Contacts:**

***Contact 1:***

- **Email:** kheyauttam@yahoo.co.in

- **Name:** Dr Kheya Ghosh, M. D.

- **Phone:** +91-9830297578

- **Role:** CONTACT

**Country:** India

**Facility:** Institute of Child Health, Kolkata

**State:** West Bengal

**Status:** NOT_YET_RECRUITING

**Zip:** 700017

**Location 9:**

**City:** Chandigarh

**Contacts:**

***Contact 1:***

- **Email:** madhugupta21@gmail.com

- **Name:** Dr Madhu Gupta, MD

- **Role:** CONTACT

**Country:** India

**Facility:** Post Graduate Institute of Medical Education and Research (PGIMER)

**Status:** NOT_YET_RECRUITING

**Zip:** 160012

#### Overall Officials

**Official 1:**

**Affiliation:** KEM Hospital Research Centre, Pune, India

**Name:** Anand Kawade

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Bharati Vidyapeeth Medical College Hospital and Research Centre, Pune, India

**Name:** Sonali Palkar

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** JSS Hospitla, Mysore, India

**Name:** M D Ravi

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

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

**Name:** Veena Kamat

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Sri Ramchndra Institute of Higher Education and Research, Chennai, India

**Name:** P Umapathy

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** Institute of Child Health, Kolkata, India

**Name:** Kheya Ghosh

**Role:** PRINCIPAL_INVESTIGATOR

**Official 7:**

**Affiliation:** Post Graduate Institute of Medical Education and Research, Chandigarh, India

**Name:** Madhu Gupta

**Role:** PRINCIPAL_INVESTIGATOR

**Official 8:**

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

**Name:** Afreen khan

**Role:** PRINCIPAL_INVESTIGATOR

**Official 9:**

**Affiliation:** Yashwantrao Chavan Memorial Hospital, Pimpri, Pune, India

**Name:** Deepali Ambike

**Role:** PRINCIPAL_INVESTIGATOR

**Official 10:**

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

**Name:** K Zaman

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**Description:** Summary results for primary and secondary objectives

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** 6 months after the study completion

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018347

- Term: Hepadnaviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000016908

- Term: Gram-Positive Bacterial Infections

- ID: D000003354

- Term: Corynebacterium Infections

- ID: D000000193

- Term: Actinomycetales Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10295

- Name: Influenza, Human

- Relevance: LOW

- As Found: Unknown

- ID: M9592

- Name: Hepatitis A

- Relevance: LOW

- As Found: Unknown

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9595

- Name: Hepatitis B

- Relevance: HIGH

- As Found: Hepatitis B

- ID: M7347

- Name: Diphtheria

- Relevance: HIGH

- As Found: Diphtheria

- ID: M17656

- Name: Whooping Cough

- Relevance: LOW

- As Found: Unknown

- ID: M16511

- Name: Tetanus

- Relevance: LOW

- As Found: Unknown

- ID: M16515

- Name: Tetany

- Relevance: LOW

- As Found: Unknown

- ID: M13939

- Name: Poliomyelitis

- Relevance: LOW

- As Found: Unknown

- ID: M9284

- Name: Haemophilus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20487

- Name: Hepadnaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M19252

- Name: Gram-Positive Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6574

- Name: Corynebacterium Infections

- Relevance: LOW

- As Found: Unknown

- ID: T1885

- Name: Diphtheria

- Relevance: HIGH

- As Found: Diphtheria

- ID: T2646

- Name: Haemophilus Influenzae

- Relevance: HIGH

- As Found: Haemophilus Influenzae

- ID: T5926

- Name: Whooping Cough

- Relevance: LOW

- As Found: Unknown

- ID: T5607

- Name: Tetanus

- Relevance: LOW

- As Found: Unknown

- ID: T4606

- Name: Poliomyelitis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006509

- Term: Hepatitis B

- ID: D000004165

- Term: Diphtheria

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: HIGH

- As Found: Other

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014612

- Term: Vaccines

### Misc Info Module

- Version Holder: 2024-05-31
