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Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

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ClinicalTrials.gov Identifier: NCT01044316
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : December 30, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:
This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III Observer-Blind, Randomized, Controlled, Single-Coordinating Center Pediatric Study in China Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Using a Local Dosing Regimen in Infants
Study Start Date : April 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2010


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 - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine.
Active Comparator: Arm 2 Biological: Haemophilus influenzae type b (Hib) vaccine
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine.



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

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


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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants 6-12 months of age.

Exclusion Criteria:

  • Prior Hib vaccine administration.
  • History of serious reaction(s) following vaccination.
  • Any vaccination within 14 days of study vaccination.
  • Known or suspected immune impairment.
  • For additional entry criteria please refer to the protocol.

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): NCT01044316


Locations
China
Hebei Province, China
Sponsors and Collaborators
Novartis Vaccines

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01044316     History of Changes
Other Study ID Numbers: V37_07
First Posted: January 7, 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
Booster

Additional relevant MeSH terms:
Infection
Influenza, Human
Diphtheria
Tetanus
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Clostridium 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