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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

NCT ID: NCT01025544

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

846 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Haemophilus Influenzae Type b (Hib) Infection

Keywords

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Haemophilus influenzae type b (Hib) Vaccine Booster

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)

Intervention Type BIOLOGICAL

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

Arm 2

Group Type ACTIVE_COMPARATOR

Hiberix (Haemophilus influenzae type b (Hib) vaccine)

Intervention Type BIOLOGICAL

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

Interventions

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Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

Intervention Type BIOLOGICAL

Hiberix (Haemophilus influenzae type b (Hib) vaccine)

Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Basel

Role: STUDY_CHAIR

41 61 324 1111

Locations

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Hebei Province, , China

Site Status

Countries

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China

Other Identifiers

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M37P2E1

Identifier Type: -

Identifier Source: org_study_id