Diphtheria, Haemophilus Infections, Hepatitis B, Pertussis, Tetanus
Conditions
Keywords
Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity
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.
Interventions
BIOLOGICALQuinvaxem in Uniject
BIOLOGICALQuinvaxem in single dose vials
Sponsors
Crucell Holland BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 64 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprotection Rate: Anti-PRP Antibodies | 1 month after the third vaccination |
| Seroprotection Rate: Anti-hepatitis B Surface Antibodies | 1 month after the third vaccination |
| Anti-diphtheria Toxoid Antibodies | 1 month after the third vaccination |
| Seroprotection Rate: Anti-tetanus Toxoid Antibodies | 1 month after the third vaccination |
| Seroprotection Rate: Anti-B. Pertussis Antibodies | 1 month after the third vaccination |
Countries
Philippines
Outcome results
None listed