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Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B

NCT ID: NCT01362517

Last Updated: 2013-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-04-30

Brief Summary

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The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule

Detailed Description

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Conditions

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Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Influenzae Infections

Keywords

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Vaccination Immunisation Virus Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Influenzae Immunity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quinvaxem

Group Type EXPERIMENTAL

Quinvaxem

Intervention Type BIOLOGICAL

A single dose (0.5 mL) of Quinvaxem contains:

diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen

One dose of Quinvaxem given at 2, 3 and 4 months of age

Interventions

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Quinvaxem

A single dose (0.5 mL) of Quinvaxem contains:

diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen

One dose of Quinvaxem given at 2, 3 and 4 months of age

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems
* Have a normal gestational age (≥ 37 weeks); birth weight \> 2.5 kg
* There is no congenital disease detected through interview and clinical examination
* Already had or not yet received Hepatitis B vaccination at birth
* Do not have dermatological diseases such as eczema, allergies
* Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures

Exclusion Criteria

* Already vaccinated with DTP vaccine
* Have an acute infection at the time of study vaccination
* Contraindications to Quinvaxem
* Receiving treatment with systemic corticosteroids
* Currently participating in another clinical trial
* In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth
* Parents intend to move to another location during the study (the next 12 months)
Minimum Eligible Age

60 Days

Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Crucell Holland BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tran Ngoc Huu, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Pasteur Institute of Ho Chi Minh City

Locations

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Pasteur Institute

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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QVX-V-C001

Identifier Type: -

Identifier Source: org_study_id