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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01917357
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Infections Biological: Quinvaxem in Uniject Biological: Quinvaxem in single dose vials Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2013
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diphtheria Tetanus
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Seroprotection Rate: Anti-PRP Antibodies [ Time Frame: 1 month after the third vaccination ]
  2. Seroprotection Rate: Anti-hepatitis B Surface Antibodies [ Time Frame: 1 month after the third vaccination ]
  3. Anti-diphtheria Toxoid Antibodies [ Time Frame: 1 month after the third vaccination ]
  4. Seroprotection Rate: Anti-tetanus Toxoid Antibodies [ Time Frame: 1 month after the third vaccination ]
  5. Seroprotection Rate: Anti-B. Pertussis Antibodies [ Time Frame: 1 month after the third vaccination ]


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Ages Eligible for Study:   42 Days to 64 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917357


Locations
Philippines
Research Institute for Tropical Medicine
Muntinlupa City, Philippines
Sponsors and Collaborators
Crucell Holland BV
Investigators
Principal Investigator: Maria RZ Capeding, MD Research Institute for Tropical Medicine (RITM)

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01917357     History of Changes
Other Study ID Numbers: QVX-V-D001
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: February 2014

Keywords provided by Crucell Holland BV:
Vaccination
Immunisation
Virus
Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Influenzae
Immunity

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Whooping Cough
Tetanus
Diphtheria
Haemophilus Infections
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Pasteurellaceae Infections
Diphtheria Antitoxin
Tetanus Antitoxin
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents