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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

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: DTP/HB/Hib vaccine Biological: DTP/HB and Hib vaccine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : July 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Biological: DTP/HB/Hib vaccine
Dosage equal to 0.5 mL administered intramuscularly
Other Name: Pentavalent

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

Biological: DTP/HB and Hib vaccine
Dosage equal to 0.5 mL administered intramuscularly




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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



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Ages Eligible for Study:   6 Weeks to 11 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986322


Locations
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Indonesia
Garuda Primary Health Center
Bandung, West Java, Indonesia
Ibrahim Adji Primary Health Care Center
Bandung, West Java, Indonesia
Puter Primary Health Center
Bandung, West Java, Indonesia
Sponsors and Collaborators
PT Bio Farma
Investigators
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Principal Investigator: Kusnandi Rusmil, PhD Faculty of Medicine UNPAD
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Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT01986322    
Other Study ID Numbers: Penta 0211
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: November 2013
Keywords provided by PT Bio Farma:
DTP/HB/Hib vaccine
Immunogenicity
Infants
Safety
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs