Antibody Persistence, Immune Response and Safety After Doses of Pentabio Vaccine

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by PT Bio Farma
Sponsor:
Information provided by (Responsible Party):
PT Bio Farma
ClinicalTrials.gov Identifier:
NCT02095314
First received: March 19, 2014
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

Measure antibody persistence prior to booster administration of Pentabio vaccine.


Condition Intervention Phase
Healthy
Biological: Pentavalen
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antibody Persistence After Primary Doses, Immune Response and Safety After Doses of Pentabio Vaccine in Indonesian Children at 18-24 Months of Age

Resource links provided by NLM:


Further study details as provided by PT Bio Farma:

Primary Outcome Measures:
  • Geomoteric mean titer prior to booster administration of Pentabio vaccine [ Time Frame: visit 1 ] [ Designated as safety issue: No ]
    The number and percentage of children with anti diphtheria titer and anti tetanus titer >=0.01 IU/ml anti HBs >=10 mIU/ml, anti Hib >=0.15 ug/ml prior to booster administration.


Secondary Outcome Measures:
  • Protectivity of Pentabio vaccine 1 month after the booster dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Serological response to diphtheria, tetanus, pertussis and Hib (Geometric Mean Titer)

  • Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Geometric mean titer to diphtheria, tetanus, pertussis, Hepatitis B and Hib before immunization and 1 month after immunization

  • Seroconversion and seroprotection before and 1 month after the booster dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The changes of serological response before and after booster dose

  • Number of participants with adverse events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Local and systemic reaction within 28 days after immunization.


Estimated Enrollment: 575
Study Start Date: March 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pentavalen
Pentabio Vaccine One dose corresponds to 0.5ml The vaccine shall be given intramuscularly
Biological: Pentavalen
Batch 5010613
Other Names:
  • Pentabio vaccine
  • DPT-HB-Hib

Detailed Description:

Number and percentage of children with anti diphtheria, titer and anti tetanus titer >= 0.01 IU/ml, anti HBs >=10mIU/ml, anti Hib >=0.15ug/ml prior to booster administration.

  Eligibility

Ages Eligible for Study:   18 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children, 18-24 months of age
  • Subjects who had completed the primary series of Pentabio vaccine in the previous trial
  • Father, mother, or legally acceptable representative have been informed properly regarding the study and signed the informed consent form
  • Subject's parents commit to comply with the instruction

Exclusion Criteria:

  • Subjects concomitantly enrolled or scheduled to be enrolled in another trial
  • Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5oC on Day 0)
  • Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
  • Known history of allergy to any component of the vaccines (e.f. formaldehyde)
  • Known history of acquired immunodeficiency (including HIV infection)
  • Subject who has received a treatment likely to alter immune response in the previous 4 weeks (e.g intravenous immunoglobulin, blood-derived products or long term corticotherapy (>2 weeks)
  • Subject receives other vaccination within 1 month prior to inclusion
  • Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives
  • Infant with a known history of diphtheria, tetanus, pertussis, Hepatitis B and Hib 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: NCT02095314

Contacts
Contact: Kusnandi Rusmil, MD +62811232774
Contact: Hartono Gunardi, MD +6281310805050

Locations
Indonesia
Ibrahim Adjie Primary Health Center Recruiting
Bandung, West Java, Indonesia
Contact: Kusnandi Rusmil, MD    +62811232774      
Sub-Investigator: Meita Dhamayanti, MD         
Puter Primary Health Centre Recruiting
Bandung, West Java, Indonesia
Contact: Kusnandi Rusmil, MD    +62811232774      
Sub-Investigator: Eddy Fadlyana, MD         
Garuda Primary Health Center Recruiting
Bandung, West Java, Indonesia
Contact: Kusnandi Rusmil, MD    +62811232774      
Sub-Investigator: Adi Utomo, MD         
Tebet Primary Health Center Recruiting
Jakarta, Indonesia
Contact: Hartono Gunardi, MD    +6281310805050      
Sub-Investigator: Rini Sekartini, MD         
Jatinegara Primary Health Center Recruiting
Jakarta, Indonesia
Contact: Hartono Gunardi, MD    +6281310805050      
Sub-Investigator: Bernie Endyarni, MD         
Mampang Prapatan Primary Health Center Recruiting
Jakarta, Indonesia
Contact: Hartono Gunardi, MD    +6281310805050      
Sub-Investigator: Hindra Irawan, MD         
Sponsors and Collaborators
PT Bio Farma
Investigators
Principal Investigator: Kusnandi Rusmil, MD Department of Child Health, School of Medicine Padjadjaran University
Principal Investigator: Hartono Gunardi, MD Department of Child Health, School of Medicine, University of Indonesia
  More Information

No publications provided

Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT02095314     History of Changes
Other Study ID Numbers: Booster Penta 0413
Study First Received: March 19, 2014
Last Updated: March 20, 2014
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by PT Bio Farma:
DTP-HB-Hib
Pentavalen
Pentabio
Booster

ClinicalTrials.gov processed this record on September 22, 2014