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

December 27, 2011 updated by: Novartis Vaccines

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

670

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hebei Province, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-PRP antibody levels at day 31 post last vaccination
Time Frame: 30 days after last vaccination
30 days after last vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Solicited local and systemic reactions, AEs, and SAEs
Time Frame: 30 days post last vaccination
30 days post last vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 3, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

December 30, 2011

Last Update Submitted That Met QC Criteria

December 27, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V37_07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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