Clinical trial NCT01986322: Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine
Official title: Phase 2 Study of Immunogenicity and Safety of DPT/HB/Hib (Bio Farma) Vaccine Compared to DTP/HB (Bio Farma) Vaccine Given Simultaneously With Hib (Registered) Vaccine in Indonesian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: DTP/HB/Hib vaccine
Immunogenicity
Infants
Safety
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 220
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 main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.

Detailed description: This trial was randomized, single blind, prospective intervention study. Total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.

Eligibility criteria: Inclusion Criteria:

* Infant 6-11 week of age
* Infant born after 37-42 week of pregnancy
* Infant weighing 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 7 days 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 diphteria toxoid in both group
timeFrame: 4 months
measure: Antibody response to Tetanus Toxoid in both group
timeFrame: 4 months
measure: Antibody response to Pertussis component in both group
timeFrame: 4 months
measure: Antibody response to Hepatitis B in both group
timeFrame: 4 months
measure: Antibody response to PRP-T in both group
timeFrame: 4 months
measure: Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
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 Care Center
state: West Java
city: Bandung
country: Indonesia
facility: Puter Primary Health Center
state: West Java
Study officials:
affiliation: Faculty of Medicine UNPAD
name: Kusnandi Rusmil, PhD
role: PRINCIPAL_INVESTIGATOR
References: