Evaluation of the immune response and safety of a booster dose of Pfizer's13-valent pneumococcal conjugate vaccine in children primed with 2 dosesof either GSK's 10-valent pneumococcal conjugate vaccine or Pfizer's 13-valent pneumococcal conjugate vaccine in the Slovak Republic

• Conditions: To induce appropriate protection against pneumococcal disease. Toassess non-inferiority of OPA response for serotype 19A after boosterdose of PCV13 administered between 11-12 months of age in subjectsprimed with 10Pn-PD-DiT vs those primed with PCV13.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-005367-27-SK
• Lead Sponsor: BIOVOMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-05
• Last Update Posted: 25 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All subjects must satisfy ALL the following criteria at study entry:
• Subjects who the investigator believes that their parent(s)/Legally
Acceptable Representative(s) (LARs) can and will comply with the
requirements of the protocol (e.g. completion of the diary cards, return
for follow-up visits).
• Written informed consent obtained from the parents/LAR(s) of the
subject.
• Healthy subjects as established by medical history and clinical
examination before entering into the study.
• Subjects between and including 11 to 12 months of age at the time of
vaccination for booster dose with PCV13.
• Previously completed two-dose vaccination course till month 6 with
either 10Pn-PD-DiT for Group 10Pn-PD-DiT or PCV13 for Group PCV13.
Are the trial subjects under 18? yes
Number of subjects for this age range: 92
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following criteria should be checked at the time of study entry for all subjects. If ANY exclusion criterion applies, the subject must not be
included in the study:
• Child in care (A child who has been placed under the control or
protection of an agency, organisation, institution or entity by the courts,
the government or a government body, acting in accordance with powers
conferred on them by law or regulation.)
• Use of any investigational or non-registered product (drug or vaccine)
other than the study vaccine within 30 days preceding the dose of study
vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) of
immunosuppressants or other immune-modifying drugs since birth. For
corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or
equivalent. Inhaled and topical steroids are allowed.
• Planned administration/administration of a vaccine not foreseen by
the study protocol during the study period starting from 30 days before
the dose and ending 30 days after the dose of vaccine(s), with the
exception of licensed influenza vaccines and licensed DTP vaccines.
The licensed influenza vaccines are always allowed, even if
concomitantly administered with the study vaccines.
Administration of any of the vaccines mentioned above has to be
documented in the Concomitant vaccination of the CRF (Case Record
Form).
• Concurrently participating in another clinical study, at any time
during the study period, in which the subject has been or will be exposed
to an investigational or a non-investigational product (pharmaceutical
product or device).
• Previous booster vaccination against S. pneumoniae.
• Any confirmed or suspected immunosuppressive or immunodeficient
condition, based on medical history and physical examination (no
laboratory testing required).
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by
any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment. Subjects with
temperature bellow 37.5°C on oral, axillary or tympanic setting, or
bellow 38.0°C on rectal setting and subjects with mild disease without
fever e.g mild diarrhea or mild URTI may be enrolled at the discreation
of the investigator.
• Administration of immunoglobulins and/or any blood products within
the 3 months preceding vaccination or planned administration during
study period.
• Any medical condition which might interfere with the assessment of
the study objectives in the opinion of the investigator.
• Anaphylaxis following previous administration of a pneumococcal
conjugate vaccine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified