Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

NCT01986335 Phase 3 COMPLETED

The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.

Details

Lead sponsor	PT Bio Farma
Phase	Phase 3
Status	COMPLETED
Enrolment	600
Start date	2012-08
Completion	2013-01

Conditions

• Healthy

Interventions

• DTP/HB/Hib Vaccine

Primary outcomes

• Protectivity of DTP/HB/Hib (Bio Farma) vaccine — 4 months
  Number and percentage of infants with anti diphteria titer and anti tetanus titer \>= 0.01 IU/ml, AntiHBs titer \>=10mlIU/ml, and antiHib titer \>= 0,15ug/ml 28 days after the last injection

Countries

Indonesia