Clinical trial NCT01917357: A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Infections
Keywords: Vaccination
Immunisation
Virus
Diphtheria
Pertussis
Tetanus
Hepatitis B
Haemophilus Influenzae
Immunity
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2013-08-06
Enrollment: 400
Sex: ALL
Minimum age (years): 42
Maximum age (years): 64
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Seroprotection Rate: Anti-PRP Antibodies
timeFrame: 1 month after the third vaccination
measure: Seroprotection Rate: Anti-hepatitis B Surface Antibodies
timeFrame: 1 month after the third vaccination
measure: Anti-diphtheria Toxoid Antibodies
timeFrame: 1 month after the third vaccination
measure: Seroprotection Rate: Anti-tetanus Toxoid Antibodies
timeFrame: 1 month after the third vaccination
measure: Seroprotection Rate: Anti-B. Pertussis Antibodies
timeFrame: 1 month after the third vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Muntinlupa City
country: Philippines
facility: Research Institute for Tropical Medicine
Study officials:
affiliation: Research Institute for Tropical Medicine (RITM)
name: Maria RZ Capeding, MD
role: PRINCIPAL_INVESTIGATOR
References: