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Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01226953
First Posted: October 22, 2010
Last Update Posted: December 30, 2011
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 booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age

Condition Intervention Phase
Haemophilus Influenzae Type b (Hib) Infection Biological: Haemophilus influenzae type b (Hib) vaccine 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 Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Vaccines ):

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

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

Enrollment: 660
Study Start Date: October 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Biological: Haemophilus influenzae type b (Hib) vaccine
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines
Active Comparator: Arm 2 Biological: Haemophilus influenzae type b (Hib) vaccine
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   365 Days to 569 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants 365-569 days of age.

Exclusion Criteria:

  • Subjects who already received a booster dose of Hib vaccine.
  • History of serious reaction(s) following vaccination.
  • Any vaccination within 7 days of study vaccination.
  • Known or suspected immune impairment.
  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): NCT01226953


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01226953     History of Changes
Other Study ID Numbers: V37_07E1
First Submitted: October 21, 2010
First Posted: October 22, 2010
Last Update Posted: December 30, 2011
Last Verified: December 2011

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs