NCT01986322

Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine

Phase 2 Study of Immunogenicity and Safety of DPT/HB/Hib (Bio Farma) Vaccine Compared to DTP/HB (Bio Farma) Vaccine Given Simultaneously With Hib (Registered) Vaccine in Indonesian Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 6 Weeks – 11 Weeks
• Healthy volunteers: Accepted

Summary

The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.

Detailed description

This trial was randomized, single blind, prospective intervention study. Total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	DTP/HB/Hib vaccine	Dosage equal to 0.5 mL administered intramuscularly
BIOLOGICAL	DTP/HB and Hib vaccine	Dosage equal to 0.5 mL administered intramuscularly

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2013-11-18
• Last updated: 2013-11-18

Locations

3 sites across 1 country: Indonesia