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

NCT01986335 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2013-11-18

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

BIOLOGICAL

DTP/HB/Hib Vaccine

DPT/HB/Hib vaccine (Bio Farma)

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Kusnandi Rusmil, PhD · Faculty of Medicine UNPAD

  • Hartono Gunardi, PhD · Faculty of Medicine UI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
11 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01986335 on ClinicalTrials.gov