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Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children

NCT ID: NCT01125527

Last Updated: 2016-12-01

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

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-04-30

Brief Summary

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This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 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 Anti PRP antibody

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)

Intervention Type BIOLOGICAL

a single dose was administered

Arm 2

Group Type ACTIVE_COMPARATOR

Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)

Intervention Type BIOLOGICAL

a single dose was administered

Interventions

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Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)

a single dose was administered

Intervention Type BIOLOGICAL

Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)

a single dose was administered

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Infants 13-59 months of age.

Exclusion Criteria

* Prior Hib vaccine administration.
* History of serious reaction(s) following vaccination.
* Any vaccination within 7 days of study vaccination.
* Known or suspected immune impairment.
* Premature (before 37th week of gestation) or birth weight less than 2500g
* For additional entry criteria please refer to the protocol.
Minimum Eligible Age

13 Months

Maximum Eligible Age

59 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

Locations

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Hebei Province, , China

Site Status

Countries

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China

Other Identifiers

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V37_06

Identifier Type: -

Identifier Source: org_study_id