A Phase 3 interventional study of Hib-CRM197 and Hib-TT in Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b, sponsored by Novartis Vaccines. Completed at 1 site in China. Open to participants aged 5 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-09.
Sponsored by Novartis Vaccines (formerly part of Novartis) · Phase 3, Interventional, and Prevention
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.
381 studies on the registry are indexed under Meningitis; 33 are open to participants now.
This study's enrollment of 426 is above the median of 215 across 262 interventional studies indexed under Meningitis.
Browse Meningitis studies →Novartis Vaccines is the lead sponsor of 165 studies on the registry; none are open to participants now.
First submitted before Novartis Vaccines left Novartis.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Treatment with corticosteroids or other immunosuppressive/immunostimulant drugs as defined below:
i) chronic use of oral and parenteral immunosuppressants (>= 15 days of use) or other immune-modifying drugs within 60 days prior to the blood sampling (short term usage of topical, inhaled and/or intranasal corticosteroids were allowed) ii) receipt of immunostimulants within 60 days prior to Visit 1
Subjects treated with 3 doses of CRM 197 -conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37\_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37\_07E1 (NCT01226953). No vaccine was administered during this trial
Biological: Hib-CRM197
Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37\_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37\_07E1 (NCT01226953). No vaccine was administered during this trial
Biological: Hib-TT
No vaccine administered in V37\_07E2 study
No vaccine administered in V37\_07E2 study
Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)
Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37\_07E1 trial.
Time frame: At Day 1 (4 years post booster dose administered in study V37_07E1)
Percentages of Subjects With Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)
Immunogenicity was measured as the percentages of subjects with Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in V37\_07E1 trial.
Time frame: At Day 1 (4 years post booster dose administered in study V37_07E1)
One center in China
| Milestone | Hib CRM197 | Hib TT |
|---|---|---|
| Started | 215 | 211 |
| Completed | 215 | 211 |
| Not completed | 0 | 0 |
Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37\_07E1 trial.
| Concentration in μg/mL | Hib CRM197 | Hib TT |
|---|---|---|
| Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1) | 2.66 (2 to 3.54) | 5.05 (3.97 to 6.42) |
Immunogenicity was measured as the percentages of subjects with Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in V37\_07E1 trial.
| Percentage of subjects | Hib CRM197 | Hib TT |
|---|---|---|
| Anti-PRP Concentrations ≥ 1.0 μg/mL | 77 (71 to 82) | 88 (83 to 92) |
| Anti-PRP Concentrations ≥ 0.15 μg/mL | 77 (71 to 82) | 88 (83 to 92) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hib CRM197 | — | — | — |
| Hib TT | — | — | — |
| Age, Continuous(years) | Hib CRM197 | Hib TT | Total |
|---|---|---|---|
| Age | 5 ± 0 | 5 ± 0 | 5 ± 0 |
| Sex: Female, Male(Participants) | Hib CRM197 | Hib TT | Total |
|---|---|---|---|
| Female | 99 | 106 | 205 |
| Male | 116 | 105 | 221 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.