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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

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ClinicalTrials.gov Identifier: NCT01226953
Recruitment Status : Completed
First Posted : October 22, 2010
Last Update Posted : December 30, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Haemophilus Influenzae Type b (Hib) Infection Biological: Haemophilus influenzae type b (Hib) vaccine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 660 participants
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
Study Start Date : October 2010
Primary Completion Date : December 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

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 Posted: October 22, 2010    Key Record Dates
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