NCT02095314

Brief Summary

Measure antibody persistence prior to booster administration of Pentabio vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
399

participants targeted

Target at P75+ for phase_2 healthy

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2 healthy

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

March 19, 2014

Last Update Submit

December 16, 2014

Conditions

Healthy

Keywords

DTP-HB-HibPentavalenPentabioBooster

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Protectivity of Pentabio vaccine 1 month after the booster dose

    1 month

  • Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose

    1 month

  • Seroconversion and seroprotection before and 1 month after the booster dose

    1 month

  • Number of participants with adverse events

    1 month

Study Arms (1)

Pentavalen

EXPERIMENTAL

Pentabio Vaccine One dose corresponds to 0.5ml The vaccine shall be given intramuscularly

Biological: Pentavalen

Interventions

PentavalenBIOLOGICAL

Batch 5010613

Also known as: Pentabio vaccine, DPT-HB-Hib
Pentavalen

Eligibility Criteria

Age18 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Jatinegara Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Location

Mampang Prapatan Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Location

Tebet Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Location

Garuda Primary Health Center

Bandung, West Java, Indonesia

Location

Ibrahim Adjie Primary Health Center

Bandung, West Java, Indonesia

Location

Puter Primary Health Centre

Bandung, West Java, Indonesia

Location

Related Publications (1)

  • 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.

    PMID: 29804542DERIVED

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 24, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

ID(6)