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Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b

NCT ID: NCT00808392

Last Updated: 2011-12-29

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

916 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-02-28

Brief Summary

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This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.

Detailed Description

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Conditions

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Haemophilus Influenzae Type b

Keywords

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vaccine prevention haemophilus influenzae type b children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

Haemophilus influenzae type b vaccine

Intervention Type BIOLOGICAL

3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine

2

Group Type ACTIVE_COMPARATOR

Commercial Haemophilus influenzae type b vaccine

Intervention Type BIOLOGICAL

3 doses one month apart of Haemophilus influenzae type b vaccine.

Interventions

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Haemophilus influenzae type b vaccine

3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine

Intervention Type BIOLOGICAL

Commercial Haemophilus influenzae type b vaccine

3 doses one month apart of Haemophilus influenzae type b vaccine.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Infants of either sex, aged 2 - 4 months
* In good health as determined by:

* medical history
* physical examination
* clinical judgment of the investigator;
* Available for all visits scheduled in the study and able to comply with all study regulations
* For whom written informed consent has been obtained from at least one parent or legal guardian

Exclusion Criteria

* Parent or legal guardian is unwilling or unable to give written informed consent to participate in study
* Infants who have received any other Haemophilus influenzae type b immunization dose before
* Infants who presented a previous disease potentially related to Haemophilus influenzae type b
* Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease
* Premature (before 37th week of gestation) or birth weight less than 2500 g
* History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
* Fever ≥ 38.0 °C (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment
* Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease
* Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
* Subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder
* Subjects with a clinically significant genetic anomaly
* Treatment with corticosteroids or other immunosuppressive drugs
* Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
* Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
* Participation in any other investigational trial simultaneously
* Planned surgery during the study period
* Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective
Minimum Eligible Age

2 Months

Maximum Eligible Age

4 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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the CDC of Dingxing county(site no 02)

Dingxing, Hebei, China

Site Status

The CDC of Zhengding county(site no 01)

Zhengding, Hebei, China

Site Status

Countries

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China

Other Identifiers

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M37P2

Identifier Type: -

Identifier Source: org_study_id