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

PT Bio Farma

Status and phase

Completed

Phase 3

Phase 2

Conditions

Healthy

Treatments

Biological: Pentavalen

Study type

Interventional

Funder types

Industry

Identifiers

NCT02095314

Booster Penta 0413

Details and patient eligibility

About

Measure antibody persistence prior to booster administration of Pentabio vaccine.

Full 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.

Enrollment

399 patients

Sex

All

Ages

18 to 24 months old

Volunteers

Accepts Healthy Volunteers

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