ClinicalTrials.Veeva

Menu

Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

Novartis logo

Novartis

Status and phase

Completed
Phase 3

Conditions

Haemophilus Influenzae Type b (Hib) Infection

Treatments

Biological: Haemophilus influenzae type b (Hib) vaccine

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.

Enrollment

670 patients

Sex

All

Ages

6 to 12 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Infants 6-12 months of age.

Exclusion criteria

  • Prior Hib vaccine administration.
  • History of serious reaction(s) following vaccination.
  • Any vaccination within 14 days of study vaccination.
  • Known or suspected immune impairment.
  • For additional entry criteria please refer to the protocol.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

670 participants in 2 patient groups

Arm 1
Active Comparator group
Treatment:
Biological: Haemophilus influenzae type b (Hib) vaccine
Arm 2
Active Comparator group
Treatment:
Biological: Haemophilus influenzae type b (Hib) vaccine

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems