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

Antibody Persistence After Primary Doses, Immune Response and Safety After Doses of Pentabio Vaccine in Indonesian Children at 18-24 Months of Age

Measure antibody persistence prior to booster administration of Pentabio vaccine.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: Pentavalen

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.

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • Jatinegara Primary Health Center
  • Jakarta, Indonesia
    • Mampang Prapatan Primary Health Center
  • Jakarta, Indonesia
    • Tebet Primary Health Center
  • West Java
    • Bandung, West Java, Indonesia
      • Garuda Primary Health Center
    • Bandung, West Java, Indonesia
      • Ibrahim Adjie Primary Health Center
    • Bandung, West Java, Indonesia
      • Puter Primary Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geomoteric mean titer prior to booster administration of Pentabio vaccine	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.	visit 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protectivity of Pentabio vaccine 1 month after the booster dose	Serological response to diphtheria, tetanus, pertussis and Hib (Geometric Mean Titer)	1 month
Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose	Geometric mean titer to diphtheria, tetanus, pertussis, Hepatitis B and Hib before immunization and 1 month after immunization	1 month
Seroconversion and seroprotection before and 1 month after the booster dose	The changes of serological response before and after booster dose	1 month
Number of participants with adverse events	Local and systemic reaction within 28 days after immunization.	1 month

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Gunardi H, Rusmil K, Fadlyana E, Soedjatmiko, Dhamayanti M, Sekartini R, Tarigan R, Satari HI, Medise BE, Sari RM, Bachtiar NS, Kartasasmita CB, Hadinegoro SRS. DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old. BMC Pediatr. 2018 May 28;18(1):177. doi: 10.1186/s12887-018-1143-6.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Estimate): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Booster; DTP-HB-Hib; Pentavalen; Pentabio
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: Booster Penta 0413