Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b Clinical Trial
Official title:
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
| Verified date | October 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 426 |
| Est. completion date | January 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 5 Years to 6 Years |
| Eligibility |
Inclusion Criteria: 1. Children previously enrolled in V37_07E1 study and who received the appropriate vaccination. 2. 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: 1. 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). 2. 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 3. Administration of immunoglobulins and/or any blood products up to 3 months before enrollment. 4. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling. 5. Any condition, which, in the opinion of the investigator, might be a contraindication to the execution of the blood draw. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| China | DingXing Center for Disease Control and Prevention | Dingxing | Hebei |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Vaccines |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At Day 1 (4 years post booster dose administered in study V37_07E1) | No |
| 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) | 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. | At Day 1 (4 years post booster dose administered in study V37_07E1) | No |