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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PT Bio Farma
ClinicalTrials.gov Identifier:
NCT01986335
First received: October 30, 2013
Last updated: November 11, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Healthy
Biological: DTP/HB/Hib Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

Resource links provided by NLM:


Further study details as provided by PT Bio Farma:

Primary Outcome Measures:
  • Protectivity of DTP/HB/Hib (Bio Farma) vaccine [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Antibody response to diphtheria between groups (three different batch numbers) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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

  • Antibody response to Tetanus between groups (three different batch numbers) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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

  • Antibody response to Pertussis component between groups (three different batch numbers) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Antibody response to Hepatitis B between groups (three different batch numbers) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Antibody response to Hib/PRP between groups (three different batch numbers) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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

  • Incidence rate of adverse event of DTP/HB/Hib (Bio Farma)vaccine between groups [ Time Frame: 30 minutes, 72 hours, 28 days after immunization ] [ Designated as safety issue: Yes ]
    Number and percentage of local reaction and systemic events following vaccination.


Enrollment: 600
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Pentavalent

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

Ages Eligible for Study:   6 Weeks to 11 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986335

Locations
Indonesia
Ibrahim Adji Primary Health Center
Bandung, West Java, Indonesia
Puter Primary Health Center
Bandung, West Java, Indonesia
Garuda Primary Health Center
Bandung, West Java, Indonesia
Tebet Primary Health Center
Jakarta, Indonesia
Jatinegara Primary Health Center
Jakarta, Indonesia
Mampang Prapatan Primary Health Center
Jakarta, Indonesia
Sponsors and Collaborators
PT Bio Farma
Investigators
Principal Investigator: Kusnandi Rusmil, PhD Faculty of Medicine UNPAD
Principal Investigator: Hartono Gunardi, PhD Faculty of Medicine UI
  More Information

No publications provided

Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT01986335     History of Changes
Other Study ID Numbers: Penta 0312
Study First Received: October 30, 2013
Last Updated: November 11, 2013
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by PT Bio Farma:
Combined pentavalent DTP/HB/Hib vaccine
Infants
Primary vaccination

ClinicalTrials.gov processed this record on September 16, 2014