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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01357720
First received: May 19, 2011
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Infections
Biological: Quinvaxem
Biological: Quinvaxem/Tritanrix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

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 ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)


Enrollment: 400
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  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 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
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: NCT01357720

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 by Crucell Holland BV

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01357720     History of Changes
Other Study ID Numbers: QVX-V-A001
Study First Received: May 19, 2011
Results First Received: March 27, 2013
Last Updated: August 29, 2013
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:
Hepatitis
Hepatitis B
Diphtheria
Haemophilus Infections
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 22, 2014