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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:
ClinicalTrials.gov Identifier:
NCT01125527
First Posted: May 18, 2010
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ( Novartis Vaccines ):

Primary Outcome Measures:
  • Anti-PRP antibody levels at day 31 post last vaccination [ Time Frame: 30 days after last vaccination ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125527


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

Additional Information:
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01125527     History of Changes
Other Study ID Numbers: V37_06
First Submitted: May 14, 2010
First Posted: May 18, 2010
Last Update Posted: December 1, 2016
Last Verified: December 2011

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

Additional relevant MeSH terms:
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Krestin
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents