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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Pertussis; Tetanus; Diphtheria; Haemophilus Infections
• Intervention / Treatment: Biological: Quinvaxem in Uniject; Biological: Quinvaxem in single dose vials

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Philippines
  • Muntinlupa City, Philippines
    • Research Institute For Tropical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: Quinvaxem in Uniject
Active Comparator: 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	Biological: Quinvaxem in single dose vials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Crucell Holland BV
• Investigators: Principal Investigator: Maria RZ Capeding, MD, Research Institute for Tropical Medicine (RITM)

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Estimate): July 15, 2014
• Last Update Submitted That Met QC Criteria: July 12, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Immunity; Vaccination; Hepatitis B; Pertussis; Immunisation; Virus; Diphtheria; Tetanus; Haemophilus Influenzae
• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Clostridium Infections; Corynebacterium Infections; Pasteurellaceae Infections; Hepatitis B; Whooping Cough; Hepatitis; Tetanus; Diphtheria; Haemophilus Infections
• Other Study ID Numbers: QVX-V-D001