The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT01977196
• Lead Sponsor: PT Bio Farma

Brief Summary

The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

Detailed Description

This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2013-10
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-05
• Last Update Submitted: 2013-11-05
• Study First Posted: 2013-11-06
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Infant 6-11 week of age
• Infant born after 37-42 week of pregnancy
• Infant weighting more than 2.5 kg at birth
• Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
• Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial

Exclusion Criteria

• Child concomitantly enroll or schedule to be enroll in another trial
• Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
• Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
• History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
• Known history of congenital or acquired immunodeficiency (including HIV infection)
• Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 minggu)
• Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
• Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)	30 minutes	Local and systemic reactions

Secondary Outcome Measures

Name	Time	Method
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)	28 hours, 48 hours, 72 hours, 28 days	Local and systemic reaction
To asses the immunogenicity	28 days	Percentage of infants with increasing antibody

Trial Locations

Locations (1)

Hasan Sadikin Hospital; 🇮🇩 Bandung, West Java, Indonesia