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Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986322
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 July 2011
Actual Primary Completion Date January 2012   (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 ]
Percentage of infants with anti diphteria titer and anti tetanus titer >= 0.01 IU/ml, AntiHbs titer >=10mlIU/ml, and antiPRP-TT titer >= 0,15ug/ml 28 days after the last injection (third) in DPT/HB/Hib liquid vaccine group
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 diphteria toxoid in both group [ 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 Toxoid in both group [ 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 in both group [ Time Frame: 4 months ]
    Serological response to the 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 in both group [ 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 PRP-T in both group [ 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/Hepatitis B/Hib vaccine (Bio Farma) [ Time Frame: 30 minutes, 72 hours, 28 days after immunization ]
    Local and systemic reaction
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 Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: DTP/HB/Hib vaccine
    Dosage equal to 0.5 mL administered intramuscularly
    Other Name: Pentavalent
  • Biological: DTP/HB and Hib vaccine
    Dosage equal to 0.5 mL administered intramuscularly
Study Arms  ICMJE
  • Experimental: DTP/HB/Hib vaccine

    Group A will receive DTP/HB/Hib combination vaccine at 6-11, 10-15 and 14-19 weeks of age.

    DTP/HB/Hib component:

    Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis HbsAg PRP-TT Aluminum phosphate Natrium Chloride Thimerosal

    Intervention: Biological: DTP/HB/Hib vaccine
  • Active Comparator: DTP/HB and Hib vaccine

    Group B will receive DTP/HB and Hib Vaccines separately at 6-11,10-15, 14-19 weeks of age

    DTP/HB component:

    Purified diphteria toxoid Purified tetanus toxoid Inactivated Bordetella pertussis rHbsAg Aluminum phosphate Natrium Chloride Thimerosal

    Hib component:

    Purified Haemophilus influenzae type b polysaccharide 10 mcg

    Intervention: Biological: DTP/HB and Hib vaccine
Publications * Not Provided

*   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)
220
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (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 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
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 NCT01986322
Other Study ID Numbers  ICMJE Penta 0211
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
PRS Account PT Bio Farma
Verification Date November 2013

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