Clinical trial NCT04071379: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immunogenicity
Safety
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 220
Sex: ALL
Minimum age (years): 0
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: 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

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.

Primary outcomes:
measure: To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk
timeFrame: 28 days after immunization
Secondary outcomes:
measure: Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria
timeFrame: 28 days after immunization
measure: Serological response to the pertussis component (agglutinins)
timeFrame: 28 days after immunization
measure: Geometric mean of anti-HbsAg
timeFrame: 28 days after immunization
measure: Serological response to Hib/PRP
timeFrame: 28 days after immunization
measure: Seroconversion
timeFrame: 28 days after immunization
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 Care
state: West Java
Study officials:
affiliation: Hasan Sadikin General Hospital
name: Eddy Fadliyana
role: PRINCIPAL_INVESTIGATOR
References: