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
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

Additional relevant MeSH terms:
Diphtheria
Influenza, Human
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Krestin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014