Phase 3
N=426
Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children
Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Bottom Line
View on ClinicalTrials.gov: NCT02139228 ↗Enrolled (actual)
426
Serious AEs
—
Results posted
Nov 2015
Primary outcome: Primary: Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1) — 2.66; 5.05 Concentration in μg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hib-CRM197 (Biological); Hib-TT (Biological)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1) |
2.66; 5.05 | — |
| SECONDARY 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) |
77; 88; 77; 88 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Children previously enrolled in V37\_07E1 study and who received the appropriate vaccination.
- Children whose parent(s) or legal guardian(s) had given written consent after the nature of the study was explained according to local regulatory requirements.
Exclusion Criteria
- Any confirmed or suspected current immunosuppressive or immunodeficient condition since the end of V37\_07E1 study, based on medical history and physical examination (no laboratory testing required).
- 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
- Administration of immunoglobulins and/or any blood products up to 3 months before enrollment.
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
- Any condition, which, in the opinion of the investigator, might be a contraindication to the execution of the blood draw.
Data sourced from ClinicalTrials.gov (NCT02139228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.