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

Study Overview
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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.

Official Title
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A Phase III, Open-label, Randomized Parallel-group Study on the Immunogenicity and Safety of Quinvaxem® DTwP-HepB-Hib) in Uniject™ With Quinvaxem® Monodose Vials in Healthy Infants at 6, 10 and 14 Weeks of Age

Conditions
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Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Infections

Intervention / Treatment
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* Biological: Quinvaxem in Uniject
* Biological: Quinvaxem in single dose vials


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 64 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quinvaxem in Uniject<br>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 | Biological: Quinvaxem in Uniject<br> <br> |
| Active Comparator: Quinvaxem in single dose vials<br>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 | Biological: Quinvaxem in single dose vials<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection Rate: Anti-PRP Antibodies |  | 1 month after the third vaccination | 
| Seroprotection Rate: Anti-hepatitis B Surface Antibodies |  | 1 month after the third vaccination | 
| Anti-diphtheria Toxoid Antibodies |  | 1 month after the third vaccination | 
| Seroprotection Rate: Anti-tetanus Toxoid Antibodies |  | 1 month after the third vaccination | 
| Seroprotection Rate: Anti-B. Pertussis Antibodies |  | 1 month after the third vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity