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

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ClinicalTrials.gov Identifier: NCT01357720
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : May 22, 2013
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 23, 2011
Results First Submitted Date  ICMJE March 27, 2013
Results First Posted Date  ICMJE May 22, 2013
Last Update Posted Date September 9, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • Seroprotection Rate: Anti-PRP Antibodies [ Time Frame: 1 month after the third vaccination ]
    Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)
  • Seroprotection Rate: Anti-hepatitis B Surface Antibodies [ Time Frame: 1 month after the third vaccination ]
    Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)
  • Seroprotection Rate: Anti-diphtheria Toxoid Antibodies [ Time Frame: 1 month after the third vaccination ]
    Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
  • Seroprotection Rate: Anti-tetanus Toxoid Antibodies [ Time Frame: 1 month after the third vaccination ]
    Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
  • Seroprotection Rate: Anti-B. Pertussis Antibodies [ Time Frame: 1 month after the third vaccination ]
    Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01357720 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • Seroprotection rate: anti-PRP antibodies [ Time Frame: 1 month after the third vaccination ]
    Percentage of subjects with an anti-PRP titer ≥1.0 µg/mL
  • Geometric mean concentrations (GMCs) [ Time Frame: 1 month after the third vaccination ]
    GMCs for anti-HBs, anti-diphtheria, anti-tetanus, anti-B. pertussis, anti-PRP antibody
  • Solicited or unsolicited local and systemic adverse events [ Time Frame: Up to 1 month after the third vaccination ]
    Percentage of subjects reporting solicited or unsolicited local and systemic adverse events after vaccination
  • Fever [ Time Frame: Up to 1 month after the third vaccination ]
    Percentage of subjects reporting fever ≥38 °C after vaccination
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Pertussis
  • Tetanus
  • Hepatitis B
  • Haemophilus Infections
Intervention  ICMJE
  • Biological: Quinvaxem

    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

  • Biological: Quinvaxem/Tritanrix

    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

Study Arms  ICMJE
  • Experimental: Quinvaxem
    Intervention: Biological: Quinvaxem
  • Active Comparator: Tritanrix Hib/HepB + Quinvaxem
    Intervention: Biological: Quinvaxem/Tritanrix
Publications * Capeding MR, Jica C, Macura-Biegun A, Rauscher M, Alberto E. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study. Vaccine. 2014 Feb 7;32(7):888-94. doi: 10.1016/j.vaccine.2013.10.059. Epub 2013 Oct 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2012)
400
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2011)
360
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 64 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01357720
Other Study ID Numbers  ICMJE QVX-V-A001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Crucell Holland BV
Study Sponsor  ICMJE Crucell Holland BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria RZ Capeding, MD Research Institute for Tropical Medicine (RITM)
PRS Account Crucell Holland BV
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP