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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

Primary Purpose

Haemophilus Influenzae Type b (Hib) Infection

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Haemophilus influenzae type b (Hib) vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Haemophilus Influenzae Type b (Hib) Infection focused on measuring Haemophilus influenzae type b (Hib), Vaccine, Booster

Eligibility Criteria

6 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Anti-PRP antibody levels at day 31 post last vaccination

Secondary Outcome Measures

Solicited local and systemic reactions, AEs, and SAEs

Full Information

First Posted
January 3, 2010
Last Updated
December 27, 2011
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01044316
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilus Influenzae Type b (Hib) Infection
Keywords
Haemophilus influenzae type b (Hib), Vaccine, Booster

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
670 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Haemophilus influenzae type b (Hib) vaccine
Intervention Description
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 Measure Information:
Title
Anti-PRP antibody levels at day 31 post last vaccination
Time Frame
30 days after last vaccination
Secondary Outcome Measure Information:
Title
Solicited local and systemic reactions, AEs, and SAEs
Time Frame
30 days post last vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
City
Hebei Province
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23964690
Citation
Jun L, Yuguo C, Zhiguo W, Jinfeng L, Huawei M, Xiuhua L, Yonggui Z, Yanhua X, Kong Y, Hongtao L, Yuliang Z. Assessment of immunogenicity and safety following primary and booster immunisation with a CRM197 -conjugated Haemophilus influenzae type B vaccine in healthy Chinese infants. Int J Clin Pract. 2013 Oct;67(10):971-8. doi: 10.1111/ijcp.12267. Epub 2013 Aug 22.
Results Reference
derived

Learn more about this trial

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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