Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: DTP/HB/Hib 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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Jatinegara Primary Health Center
  • Jakarta, Indonesia
    • Mampang Prapatan Primary Health Center
  • Jakarta, Indonesia
    • Tebet Primary Health Center
  • West Java
    • Bandung, West Java, Indonesia
      • Garuda Primary Health Center
    • Bandung, West Java, Indonesia
      • Puter Primary Health Center
    • Bandung, West Java, Indonesia
      • Ibrahim Adji Primary Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DTP/HB/Hib Vaccine (Batch: A); Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal	Biological: DTP/HB/Hib Vaccine; DPT/HB/Hib vaccine (Bio Farma); Other Names: Pentavalent
Experimental: DTP/HB/Hib vaccine (Batch: B); Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal	Biological: DTP/HB/Hib Vaccine; DPT/HB/Hib vaccine (Bio Farma); Other Names: Pentavalent
Experimental: DTP/HB/Hib vaccine (Batch: C); Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal	Biological: DTP/HB/Hib Vaccine; DPT/HB/Hib vaccine (Bio Farma); Other Names: Pentavalent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protectivity of DTP/HB/Hib (Bio Farma) vaccine	Number and percentage of infants with anti diphteria titer and anti tetanus titer >= 0.01 IU/ml, AntiHBs titer >=10mlIU/ml, and antiHib titer >= 0,15ug/ml 28 days after the last injection	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody response to diphtheria between groups (three different batch numbers)	Serological response to Diphteria toxoid: GMT, percentage of infants with titer >=0.01 IU/ml and >=0.1 IU/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive	4 months
Antibody response to Tetanus between groups (three different batch numbers)	Serological response to Tetanus toxoid: GMT, percentage of infants with titer >=0.01 IU/ml and >=0.1 IU/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive	4 months
Antibody response to Pertussis component between groups (three different batch numbers)	Serological response to Pertussis component (agglutinins): GMT,percentage of infants with titre >=40, >=80,>=160 and >=320 (1/dil.), percentage of infants with increasing antibody titer >=4 times.	4 months
Antibody response to Hepatitis B between groups (three different batch numbers)	Serological response to Hepatitis B: Geometric mean of anti-HBs,percentage of infants with titer >=10mlIU/ml, percentage of infants with increasing antibody titer >=4 times and/ or percentage of infants with transition of seronegative to seropositive.	4 months
Antibody response to Hib/PRP between groups (three different batch numbers)	Serological response to Hib/PRP: GMT, percentage of infants with titre >=1ug/ml and >=0.15ug/ml, percentage of infants with increasing antibody titer >=4 times and/or percentage of infants with transition of seronegative to seropositive	4 months
Incidence rate of adverse event of DTP/HB/Hib (Bio Farma)vaccine between groups	Number and percentage of local reaction and systemic events following vaccination.	30 minutes, 72 hours, 28 days after immunization

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Investigators: Principal Investigator: Hartono Gunardi, PhD, Faculty of Medicine UI

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: November 11, 2013
• First Posted (Estimate): November 18, 2013

Study Record Updates

• Last Update Posted (Estimate): November 18, 2013
• Last Update Submitted That Met QC Criteria: November 11, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Infants; Primary vaccination; Combined pentavalent DTP/HB/Hib vaccine
• Other Study ID Numbers: Penta 0312