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

NCT ID: NCT02095314

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-12-31

Brief Summary

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Measure antibody persistence prior to booster administration of Pentabio vaccine.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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DTP-HB-Hib Pentavalen Pentabio Booster

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pentavalen

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

Group Type EXPERIMENTAL

Pentavalen

Intervention Type BIOLOGICAL

Batch 5010613

Interventions

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Pentavalen

Batch 5010613

Intervention Type BIOLOGICAL

Other Intervention Names

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Pentabio vaccine DPT-HB-Hib

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PT Bio Farma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kusnandi Rusmil, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Child Health, School of Medicine Padjadjaran University

Hartono Gunardi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Child Health, School of Medicine, University of Indonesia

Locations

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Jatinegara Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Mampang Prapatan Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Tebet Primary Health Center

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Garuda Primary Health Center

Bandung, West Java, Indonesia

Site Status

Ibrahim Adjie Primary Health Center

Bandung, West Java, Indonesia

Site Status

Puter Primary Health Centre

Bandung, West Java, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type DERIVED
PMID: 29804542 (View on PubMed)

Other Identifiers

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Booster Penta 0413

Identifier Type: -

Identifier Source: org_study_id