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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095314
• Other study ID #: Booster Penta 0413
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 19, 2014
• Last updated: December 16, 2014
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial Summary

Measure antibody persistence prior to booster administration of Pentabio vaccine.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 24 Months

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Pentavalen
Batch 5010613

Locations

Country	Name	City	State
Indonesia	Garuda Primary Health Center	Bandung	West Java
Indonesia	Ibrahim Adjie Primary Health Center	Bandung	West Java
Indonesia	Puter Primary Health Centre	Bandung	West Java
Indonesia	Jatinegara Primary Health Center	Jakarta
Indonesia	Mampang Prapatan Primary Health Center	Jakarta
Indonesia	Tebet Primary Health Center	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Protectivity of Pentabio vaccine 1 month after the booster dose	Serological response to diphtheria, tetanus, pertussis and Hib (Geometric Mean Titer)	1 month	No
Secondary	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	No
Secondary	Seroconversion and seroprotection before and 1 month after the booster dose	The changes of serological response before and after booster dose	1 month	No
Secondary	Number of participants with adverse events	Local and systemic reaction within 28 days after immunization.	1 month	Yes