Clinical trial NCT01357720: Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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: 2011-05-23
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 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.


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 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

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: Seroprotection Rate: 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:
citation: Capeding MR, Jica C, Macura-Biegun A, Rauscher M, Alberto E. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study. Vaccine. 2014 Feb 7;32(7):888-94. doi: 10.1016/j.vaccine.2013.10.059. Epub 2013 Oct 29.