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

Novartis

Status and phase: Completed; Phase 3

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

Treatments: Biological: Hib-TT; Biological: Hib-CRM197

Study type: Interventional

Funder types: Industry

Identifiers

NCT02139228

V37_07E2

Details and patient eligibility

About

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.

Enrollment: 426 patients

Sex: All

Ages: 5 to 6 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

426 participants in 2 patient groups

Hib CRM197

Experimental group

Description:

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

Treatment:

Biological: Hib-CRM197

Hib TT

Active Comparator group

Description:

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

Treatment:

Biological: Hib-TT