At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 426 enrolled
Drug / intervention
Hib-CRM197 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIIb, Controlled, Open Label, Single-Center, Persistency, Extension Study in Chinese Children After a 2+1 Dose Series of Either CRM197-Conjugate Haemophilus Influenzae Type b Vaccine or Tetanus Toxoid-Conjugate Haemophilus Influenzae Type b Vaccine
In Brief
A Phase 3 clinical trial evaluating Hib-CRM197 and Hib-TT for Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b. Completed, enrolled 426 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartNov 2014
Primary CompletionDec 2014
Study CompletionJan 2015
TodayJul 2026
First PostedMay 15, 2014
Enrollment StartNov 1, 2014
Primary CompletionDec 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 12.1 years ago
Interventions
Hib-CRM197biological
No vaccine administered in V37\_07E2 study
Hib-TTbiological
No vaccine administered in V37\_07E2 study