## Protocol Section
### Identification Module
**NCT ID:** NCT04071379

**Brief Title:** Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B

**Official Title:** Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose (Using Different Source of Hepatitis B), in Indonesian Infants

#### Organization Study ID Info
**ID:** Penta BS19
#### Organization
**Class:** INDUSTRY
**Full Name:** PT Bio Farma
### Status Module
#### Completion Date
**Date:** 2021-12-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-01-18

**Type:** ACTUAL

**Last Update Submit Date:** 2022-01-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-04-06

**Type:** ACTUAL

#### Start Date
**Date:** 2020-10-13

**Type:** ACTUAL

**Status Verified Date:** 2022-01

#### Study First Post Date
**Date:** 2019-08-28
**Type:** ACTUAL
**Study First Submit Date:** 2019-08-26
**Study First Submit QC Date:** 2019-08-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** PT Bio Farma

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B

**Detailed Description:** Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants

### Conditions Module

**Conditions:**

- Immunogenicity

- Safety

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention Study

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Randomized, double blind, 2 arms parallel group, prospective intervention study This study will do the lot to lot consistency and will be compared to registered product

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 220

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Recombinant Hepatitis B + DTP-HB-Hib batch 1

**Intervention Names:**

- Biological: Recombinant Hepatitis B + DTP-HB-Hib

**Label:** HepB + Penta batch 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Recombinant Hepatitis B + Pentabio (registered)

**Intervention Names:**

- Biological: Hep B + Pentabio (registered)

**Label:** Hep B + Pentabio (registered)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HepB + Penta batch 1

**Description:** 1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib

**Name:** Recombinant Hepatitis B + DTP-HB-Hib

**Other Names:**

- Hep B + DTP-HB-Hib

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Hep B + Pentabio (registered)

**Description:** 1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)

**Name:** Hep B + Pentabio (registered)

**Other Names:**

- Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma)

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of infants with anti-diphtheria titer and anti-tetanus titer \> 0.01 IU/ml, anti HbsAg titer \> 10 mIU/ml, and anti PRP-T titer \> 0.15 ug/ml 28 days after the last injection of DTP/HB/Hib with different source of Hepatitis B bulk vaccine group.

**Measure:** To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk

**Time Frame:** 28 days after immunization

#### Secondary Outcomes

**Description:** Serological response to diphtheria toxoid, tetanus toxoid: GMT, percentage of infants with titer \> 0.01 IU/ml, \> 0.1 IU/ml percentage of infants with increasing antibody titer \> 4 times and/or percentage of infants with transition of seronegative to seropositive

**Measure:** Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria

**Time Frame:** 28 days after immunization

**Description:** Serological response to the pertussis component (agglutinins): GMT, percentage of infants with titer \> 40, \> 80, \> 160 and \> 320 (1/dil.), percentage of infants with increasing antibody titer \> 4 times

**Measure:** Serological response to the pertussis component (agglutinins)

**Time Frame:** 28 days after immunization

**Description:** Geometric mean of anti-HbsAg, percentage of infants with titer \> 10mIU/ml, percentage of infants with increasing antibody titer \> 4 times and/ or percentage of infants with transition of seronegative to seropositive

**Measure:** Geometric mean of anti-HbsAg

**Time Frame:** 28 days after immunization

**Description:** Serological response to Hib/PRP: GMT, percentage of infants with titer \>1 ug /ml ; \> 0.15 ug /ml percentage of infants with increasing antibody titer \> 4 times and/or percentage of infants with transition of seronegative to seropositive

**Measure:** Serological response to Hib/PRP

**Time Frame:** 28 days after immunization

**Description:** Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer \> 4 times and/ or percentage of subjects with transition of seronegative to seropositive following primary series of investigational product compare to control.

**Measure:** Seroconversion

**Time Frame:** 28 days after immunization

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy, full term, newborns infants.
* Infant born after 37-42 weeks of pregnancy.
* Infant weighing 2500 gram or more at birth.
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
* Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.

Exclusion Criteria:

* Child concomitantly enrolled or scheduled to be enrolled in another trial.
* Mother with HBsAg positive.
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>37.5C on Day 0).
* Suspected of allergy to any component of the vaccines (e.g. formaldehyde).
* Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
* Newborn suspected of congenital or acquired immunodeficiency (including HIV infection).
* Received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)).
* Received other vaccination with the exception of BCG and poliomyelitis.
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.

**Healthy Volunteers:** True

**Maximum Age:** 3 Days

**Minimum Age:** 0 Days

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bandung

**Country:** Indonesia

**Facility:** Garuda Primary Health Centre

**State:** West Java

**Location 2:**

**City:** Bandung

**Country:** Indonesia

**Facility:** Ibrahim Adjie Primary Health Centre

**State:** West Java

**Location 3:**

**City:** Bandung

**Country:** Indonesia

**Facility:** Puter Primary Health Care

**State:** West Java

#### Overall Officials

**Official 1:**

**Affiliation:** Hasan Sadikin General Hospital

**Name:** Eddy Fadliyana

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000018347

- Term: Hepadnaviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: LOW

- As Found: Unknown

- ID: M9595

- Name: Hepatitis B

- Relevance: HIGH

- As Found: Hepatitis B

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9284

- Name: Haemophilus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal 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: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006509

- Term: Hepatitis B

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: FiAg

- Name: Fibrinolytic Agents

- Abbrev: AnCoag

- Name: Anticoagulants

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

- ID: M175476

- Name: PENTA

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
