Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children

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.

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

Conditions
-----------------
Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b

Intervention / Treatment
-----------------
* Biological: Hib-CRM197
* Biological: Hib-TT


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hib CRM197<br>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<br>* No vaccine administered in V37_07E2 study<br>|
| Active Comparator: Hib TT<br>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<br>* No vaccine administered in V37_07E2 study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemophilus influenzae type b, persistency, children, CRM197, anti-PRP antibody