CompletedPhase 3

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

China426 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range5 Years – 6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✕. 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.

What they're measuring

Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)

Timeframe: At Day 1 (4 years post booster dose administered in study V37_07E1)

Trial details

NCT IDNCT02139228

SponsorNovartis Vaccines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-12

Results submitted2015-05-19

View on ClinicalTrials.gov More Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b trials