Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China

December 7, 2011 updated by: Novartis Vaccines

A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection

This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

846

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

1 year to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Toddlers 12-18 months of age who have previously participated in study M37P2.

Exclusion Criteria:

  • Prior Hib booster administration.
  • History of serious reaction(s) following vaccination.
  • 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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 2
Biological: Hiberix (Haemophilus influenzae type b (Hib) vaccine)
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
ACTIVE_COMPARATOR: Arm 1
Biological: Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Novartis Vaccines

Investigators

  • Study Chair: Novartis Basel, 41 61 324 1111

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

September 1, 2009

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (ESTIMATE)

December 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 7, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M37P2E1

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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