A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-04-30

Brief Summary

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This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.

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Detailed Description

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Conditions

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Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Quinvaxem in Uniject

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 intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using the Uniject pre-filled injection device

Group Type EXPERIMENTAL

Quinvaxem in Uniject

Intervention Type BIOLOGICAL

Quinvaxem in single dose vials

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 intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using a needle and syringe from single dose vials

Group Type ACTIVE_COMPARATOR

Quinvaxem in single dose vials

Intervention Type BIOLOGICAL

Interventions

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Quinvaxem in Uniject

Intervention Type BIOLOGICAL

Quinvaxem in single dose vials

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
* Written informed consent obtained from parents/legal guardians of the subject
* Free of obvious health problems as established by medical history and/or clinical examination before entering the study
* HepB vaccination at birth (within 48 hours)
* Available for all scheduled study visits

Exclusion Criteria

* Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up
* Planned administration of a vaccine not foreseen by the Study Protocol
* Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)
* Administration of parenteral immunoglobulin preparation and/or blood products since birth
* Previous vaccination against Hib and/or DTP
* History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal
* Clinically significant acute infection
* Clinically significant acute illness
* Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
* Participation in another clinical study

Minimum Eligible Age

42 Days

Maximum Eligible Age

64 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes