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

Healthy Clinical Trial

Official title:

Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977196
• Other study ID #: Penta 0111
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2013
• Last updated: November 5, 2013
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: October 2013
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 11 Weeks

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• DPT/HepatitisB/Hib vaccine
DPT/HepatitisB/Hib vaccine (Bio Farma)

Locations

Country	Name	City	State
Indonesia	Hasan Sadikin Hospital	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)	Local and systemic reactions	30 minutes	Yes
Secondary	Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)	Local and systemic reaction	28 hours, 48 hours, 72 hours, 28 days	Yes
Secondary	To asses the immunogenicity	Percentage of infants with increasing antibody	28 days	No