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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01917357
First received: August 5, 2013
Last updated: July 12, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Infections
Biological: Quinvaxem in Uniject
Biological: Quinvaxem in single dose vials
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Seroprotection Rate: Anti-PRP Antibodies [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]
  • Seroprotection Rate: Anti-hepatitis B Surface Antibodies [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]
  • Anti-diphtheria Toxoid Antibodies [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]
  • Seroprotection Rate: Anti-tetanus Toxoid Antibodies [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]
  • Seroprotection Rate: Anti-B. Pertussis Antibodies [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: September 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   42 Days to 64 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01917357     History of Changes
Other Study ID Numbers: QVX-V-D001
Study First Received: August 5, 2013
Last Updated: July 12, 2014
Health Authority: Philippines: Bureau of Food and Drugs

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

Additional relevant MeSH terms:
Diphtheria
Haemophilus Infections
Hepatitis
Hepatitis B
Actinomycetales Infections
Bacterial Infections
Corynebacterium Infections
Digestive System Diseases
DNA Virus Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Pasteurellaceae Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014