Clinical trial NCT02095314: Antibody Persistence, Immune Response and Safety After Doses of Pentabio Vaccine
Official title: Antibody Persistence After Primary Doses, Immune Response and Safety After Doses of Pentabio Vaccine in Indonesian Children at 18-24 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy
Keywords: DTP-HB-Hib
Pentavalen
Pentabio
Booster
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2014-03-24
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Measure antibody persistence prior to booster administration of Pentabio vaccine.

Detailed description: Number and percentage of children with anti diphtheria, titer and anti tetanus titer \>= 0.01 IU/ml, anti HBs \>=10mIU/ml, anti Hib \>=0.15ug/ml prior to booster administration.

Eligibility criteria: Inclusion Criteria:

* Children, 18-24 months of age
* Subjects who had completed the primary series of Pentabio vaccine in the previous trial
* Father, mother, or legally acceptable representative have been informed properly regarding the study and signed the informed consent form
* Subject's parents commit to comply with the instruction

Exclusion Criteria:

* Subjects concomitantly enrolled or scheduled to be enrolled in another trial
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5oC on Day 0)
* Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
* Known history of allergy to any component of the vaccines (e.f. formaldehyde)
* Known history of acquired immunodeficiency (including HIV infection)
* Subject who has received a treatment likely to alter immune response in the previous 4 weeks (e.g intravenous immunoglobulin, blood-derived products or long term corticotherapy (\>2 weeks)
* Subject receives other vaccination within 1 month prior to inclusion
* Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives
* Infant with a known history of diphtheria, tetanus, pertussis, Hepatitis B and Hib infection

Primary outcomes:
measure: Geomoteric mean titer prior to booster administration of Pentabio vaccine
timeFrame: visit 1
Secondary outcomes:
measure: Protectivity of Pentabio vaccine 1 month after the booster dose
timeFrame: 1 month
measure: Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose
timeFrame: 1 month
measure: Seroconversion and seroprotection before and 1 month after the booster dose
timeFrame: 1 month
measure: Number of participants with adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Garuda Primary Health Center
state: West Java
city: Bandung
country: Indonesia
facility: Ibrahim Adjie Primary Health Center
state: West Java
city: Bandung
country: Indonesia
facility: Puter Primary Health Centre
state: West Java
city: Jakarta
country: Indonesia
facility: Jatinegara Primary Health Center
city: Jakarta
country: Indonesia
facility: Mampang Prapatan Primary Health Center
city: Jakarta
country: Indonesia
facility: Tebet Primary Health Center
Study officials:
affiliation: Department of Child Health, School of Medicine Padjadjaran University
name: Kusnandi Rusmil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Child Health, School of Medicine, University of Indonesia
name: Hartono Gunardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gunardi H, Rusmil K, Fadlyana E, Soedjatmiko, Dhamayanti M, Sekartini R, Tarigan R, Satari HI, Medise BE, Sari RM, Bachtiar NS, Kartasasmita CB, Hadinegoro SRS. DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old. BMC Pediatr. 2018 May 28;18(1):177. doi: 10.1186/s12887-018-1143-6.