Clinical trial NCT01986335: Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
Official title: Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Combined pentavalent DTP/HB/Hib vaccine
Infants
Primary vaccination
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.

Detailed description: This trial was randomized, double blind, prospective intervention and multi centers. Total 600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258 subjects were recruited in Jakarta.

Eligibility criteria: Inclusion Criteria:

* Infant 6-11 week of age
* Infant born after 37-42 week of pregnancy
* Infant weighting more than 2.5 kg at birth
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
* Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
* Mother at least graduate from elementary school
* Received Hepatitis B vaccine (Bio Farma) at birth

Exclusion Criteria:

* Child concomitantly enroll or schedule to be enroll in another trial
* Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5 Celsius on Day 0)
* Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
* History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
* Known history of congenital or acquired immunodeficiency (including HIV infection)
* Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (\>2 weeks)
* Other vaccination within the 1 month prior to inclusion 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 objective
* Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection

Primary outcomes:
measure: Protectivity of DTP/HB/Hib (Bio Farma) vaccine
timeFrame: 4 months
Secondary outcomes:
measure: Antibody response to diphtheria between groups (three different batch numbers)
timeFrame: 4 months
measure: Antibody response to Tetanus between groups (three different batch numbers)
timeFrame: 4 months
measure: Antibody response to Pertussis component between groups (three different batch numbers)
timeFrame: 4 months
measure: Antibody response to Hepatitis B between groups (three different batch numbers)
timeFrame: 4 months
measure: Antibody response to Hib/PRP between groups (three different batch numbers)
timeFrame: 4 months
measure: Incidence rate of adverse event of DTP/HB/Hib (Bio Farma)vaccine between groups
timeFrame: 30 minutes, 72 hours, 28 days after immunization
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Garuda Primary Health Center
state: West Java
city: Bandung
country: Indonesia
facility: Ibrahim Adji Primary Health Center
state: West Java
city: Bandung
country: Indonesia
facility: Puter Primary Health Center
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: Faculty of Medicine UNPAD
name: Kusnandi Rusmil, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine UI
name: Hartono Gunardi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rusmil K, Gunardi H, Fadlyana E, Soedjatmiko, Dhamayanti M, Sekartini R, Satari HI, Risan NA, Prasetio D, Tarigan R, Garheni R, Milanti M, Hadinegoro SR, Tanuwidjaja S, Bachtiar NS, Sari RM. The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule. BMC Pediatr. 2015 Dec 19;15:219. doi: 10.1186/s12887-015-0525-2.