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

Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071379
• Other study ID #: Penta BS19
• Status: Completed
• Phase: Phase 3
• Start date: October 13, 2020
• Est. completion date: December 16, 2021

Study information

• Verified date: January 2022
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 16, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Immunogenicity
• Safety

Intervention

Biological:
• Recombinant Hepatitis B + DTP-HB-Hib
1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib
• Hep B + Pentabio (registered)
1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)

Locations

Country	Name	City	State
Indonesia	Garuda Primary Health Centre	Bandung	West Java
Indonesia	Ibrahim Adjie Primary Health Centre	Bandung	West Java
Indonesia	Puter Primary Health Care	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk	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.	28 days after immunization
Secondary	Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria	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	28 days after immunization
Secondary	Serological response to the pertussis component (agglutinins)	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	28 days after immunization
Secondary	Geometric mean of anti-HbsAg	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	28 days after immunization
Secondary	Serological response to Hib/PRP	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	28 days after immunization
Secondary	Seroconversion	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.	28 days after immunization