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

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ClinicalTrials.gov Identifier: NCT01986335
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
PT Bio Farma

Tracking Information
First Submitted Date  ICMJE October 30, 2013
First Posted Date  ICMJE November 18, 2013
Last Update Posted Date November 18, 2013
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
Protectivity of DTP/HB/Hib (Bio Farma) vaccine [ Time Frame: 4 months ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
  • Antibody response to diphtheria between groups (three different batch numbers) [ Time Frame: 4 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Number and percentage of local reaction and systemic events following vaccination.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
Official Title  ICMJE Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE Biological: DTP/HB/Hib Vaccine
DPT/HB/Hib vaccine (Bio Farma)
Other Name: Pentavalent
Study Arms  ICMJE
  • Experimental: DTP/HB/Hib Vaccine (Batch: A)
    Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
    Intervention: Biological: DTP/HB/Hib Vaccine
  • Experimental: DTP/HB/Hib vaccine (Batch: B)
    Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
    Intervention: Biological: DTP/HB/Hib Vaccine
  • Experimental: DTP/HB/Hib vaccine (Batch: C)
    Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal
    Intervention: Biological: DTP/HB/Hib Vaccine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2013)
600
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 11 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01986335
Other Study ID Numbers  ICMJE Penta 0312
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PT Bio Farma
Study Sponsor  ICMJE PT Bio Farma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kusnandi Rusmil, PhD Faculty of Medicine UNPAD
Principal Investigator: Hartono Gunardi, PhD Faculty of Medicine UI
PRS Account PT Bio Farma
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP