Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01125527
First received: May 14, 2010
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.


Condition Intervention Phase
Haemophilus Influenzae Type b (Hib) Infection
Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)
Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Anti-PRP antibody levels at day 31 post last vaccination [ Time Frame: 30 days after last vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Solicited local and systemic reactions, AEs, and SAEs [ Time Frame: 30 days post last vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 700
Study Start Date: August 2009
Study Completion Date: April 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)
a single dose was administered
Active Comparator: Arm 2 Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)
a single dose was administered

  Eligibility

Ages Eligible for Study:   13 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants 13-59 months of age.

Exclusion Criteria:

  • Prior Hib vaccine administration.
  • History of serious reaction(s) following vaccination.
  • Any vaccination within 7 days of study vaccination.
  • Known or suspected immune impairment.
  • Premature (before 37th week of gestation) or birth weight less than 2500g
  • For additional entry criteria please refer to the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125527

Locations
China
Hebei Province, China
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01125527     History of Changes
Other Study ID Numbers: V37_06
Study First Received: May 14, 2010
Last Updated: December 27, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Haemophilus influenzae type b (Hib)
Vaccine
Anti PRP antibody

ClinicalTrials.gov processed this record on October 21, 2014