drugset / Trial / NCT02139228

Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children

NCT02139228 ↗

Phase 3 Completed 426 enrolled Novartis Vaccines
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Evaluate the persistency of immune response against Haemophilus influenzae type b by assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT booster vaccine approximately 4 years before.

Timeline

Start
2014-11
Primary completion
2014-12
Completion
2015-01

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Hib CRM197 vs Hib TT; Vaccine Group Ratios 0.53 (95% CI 0.36 to 0.76); ANOVA NCT02139228 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Hib-CRM197 Vaccine — —
Comparator Hib-TT Vaccine — —