Clinical trial NCT05482282: Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)
Official title: Comparison of Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose Using New Hepatitis B Bulk (Bio Farma), in Indonesian Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diphtheria Vaccine Adverse Reaction
Tetanus Vaccine Adverse Reaction
Pertussis Vaccine Adverse Reaction
Haemophilus Influenzae Type B Vaccine Adverse Reaction
Hepatitis B Vaccine Adverse Reaction
Keywords: DTP-HB-Hib Vaccine
Hepatitis B Vaccine
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Hasan Sadikin General Hospital
First posted: 2022-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention study
Primary purpose: PREVENTION

Brief summary: This bridging study is a randomized, double-blind, two arms parallel group, prospective intervention study. The primary objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma).

Detailed description: This bridging study is a randomized, double blind, two arms parallel groups, prospective intervention study. Total 220 infants, 0-3 days old will be involved in this study. The subject will be divided into 2 groups, 110 subjects are the investigational group and 110 subjects are the active comparator group.

The objective of this study is to evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma) and to asses the safety of DTP-HB-Hib Vaccine (Bio Farma) and Recombinant Hepatitis B Vaccine using new Hepatitis B bulk (Bio Farma).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Child concomitantly enrolled or scheduled to be enrolled in another trial.
2. Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0).
3. Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis.
4. Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis
5. Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis
6. Child received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)).
7. Child received other vaccination with the exception of BCG and poliomyelitis.
8. Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
9. Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth)
10. Mother suspected of immunodeficiency disease based on anamnesis

Primary outcomes:
measure: To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) using new Hepatitis B bulk (Bio Farma)
timeFrame: 28 days
Secondary outcomes:
measure: To asses the local and systemic reactions within 30 minutes
timeFrame: 30 minutes
measure: To asses the local and systemic reactions within 30 minutes to 7 days after immunization
timeFrame: 7 days
measure: To asses the local and systemic reactions within 7 days to 28 days after immunization
timeFrame: 28 days
measure: To asses the serious adverse event
timeFrame: 28 days
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Garuda Primary Health Centre
state: West Java
city: Bandung
country: Indonesia
facility: Ibrahim Adjie Primary Health Centre
state: West Java
city: Bandung
country: Indonesia
facility: Puter Primary Health Centre
state: West Java
Study officials:
affiliation: Hasan Sadikin General Hospital
name: Eddy Fadlyana, MD
role: PRINCIPAL_INVESTIGATOR
References: