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

C

Crucell

Status and phase

Completed
Phase 3

Conditions

Diphtheria
Haemophilus Infections
Hepatitis B
Tetanus
Pertussis

Treatments

Biological: Quinvaxem in single dose vials
Biological: Quinvaxem in Uniject

Study type

Interventional

Funder types

Industry

Identifiers

NCT01917357
QVX-V-D001

Details and patient eligibility

About

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.

Enrollment

400 patients

Sex

All

Ages

42 to 64 days old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

Quinvaxem in Uniject
Experimental group
Description:
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
Treatment:
Biological: Quinvaxem in Uniject
Quinvaxem in single dose vials
Active Comparator group
Description:
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
Treatment:
Biological: Quinvaxem in single dose vials

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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