NCT02139228CompletedPhase 3
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
Novartis Vaccines1 site in 1 country426 target enrollmentStarted: November 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 426
- Locations
- 1
- Primary Endpoint
- Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)
Time Frame: 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.
Secondary Outcomes
- 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)(At Day 1 (4 years post booster dose administered in study V37_07E1))
Investigators
Study Sites (1)
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