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Vaccine

Shan 5 Lot No 1 for Whooping Cough

Phase 4
Waitlist Available
Research Sponsored by Shantha Biotechnics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.

Eligible Conditions
  • Whooping Cough
  • Hepatitis B
  • Haemophilus Influenzae
  • Tetanus
  • Diphtheria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Group I: Shan 5 Lot No 3Experimental Treatment1 Intervention
Group II: Shan 5 Lot No 2Experimental Treatment1 Intervention
Group III: Shan 5 Lot No 1Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shan 5
2008
Completed Phase 4
~150

Find a Location

Who is running the clinical trial?

Shantha Biotechnics LimitedLead Sponsor
15 Previous Clinical Trials
103,273 Total Patients Enrolled
2 Trials studying Whooping Cough
304 Patients Enrolled for Whooping Cough
Raman Rao, MDStudy DirectorShantha Biotechnics Limited
6 Previous Clinical Trials
780 Total Patients Enrolled
2 Trials studying Whooping Cough
304 Patients Enrolled for Whooping Cough
~180 spots leftby Sep 2025
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