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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Infections Biological: Quinvaxem Biological: Quinvaxem/Tritanrix Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Quinvaxem 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
Active Comparator: Tritanrix Hib/HepB + Quinvaxem 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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)


Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT01357720


Locations
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Philippines
Research Institute for Tropical Medicine
Muntinlupa City, Philippines
Sponsors and Collaborators
Crucell Holland BV
Investigators
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Principal Investigator: Maria RZ Capeding, MD Research Institute for Tropical Medicine (RITM)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01357720    
Other Study ID Numbers: QVX-V-A001
First Posted: May 23, 2011    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: September 9, 2013
Last Verified: August 2013
Keywords provided by Crucell Holland BV:
Vaccination
Immunisation
Virus
Diphtheria
Pertussis
 Tetanus
Hepatitis B
Haemophilus Influenzae
Immunity
Additional relevant MeSH terms:
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Hepatitis B
Whooping Cough
Tetanus
Diphtheria
Haemophilus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Blood-Borne Infections
Communicable Diseases
 Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Pasteurellaceae Infections