Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination

Study Overview
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Brief Summary
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This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, 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) 1 month after completion of the 6-10-14 week vaccination course.

Official Title
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A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age

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

Intervention / Treatment
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* Biological: Quinvaxem
* Biological: Quinvaxem/Tritanrix


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 guardian of the subject Free of obvious health problems as established by medical history and/or clinical examination before entering the study Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study visits Exclusion Criteria: Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of study vaccine, or 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 Human immunodeficiency virus (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 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 Haemophilus influenzae type b (Hib) and/or diphtheria, tetanus, pertussis (DTP) History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component or to products containing mercury compounds, such as sodium ethylmercuro-thiosalicylate Significant acute infection Any condition which, 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quinvaxem<br> | Biological: Quinvaxem<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 at Weeks 6, 10 and 14<br>|
| Active Comparator: Tritanrix Hib/HepB + Quinvaxem<br> | Biological: Quinvaxem/Tritanrix<br>* A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), inactive pertussis bacteria (>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection Rate: Anti-PRP Antibodies | Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate) | 1 month after the third vaccination | 
| Seroprotection Rate: Anti-hepatitis B Surface Antibodies | Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate) | 1 month after the third vaccination | 
| Seroprotection Rate: Anti-diphtheria Toxoid Antibodies | Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate) | 1 month after the third vaccination | 
| Seroprotection Rate: Anti-tetanus Toxoid Antibodies | Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate) | 1 month after the third vaccination | 
| Seroprotection Rate: Anti-B. Pertussis Antibodies | Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate) | 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