Estudio en fase III abierto, para evaluar la seguridad, reactogenicidad e inmunogenicidad de una dosis de recuerdo de la vacuna antineumocócica conjugada 10-valente de GlaxoSmithKline (GSK) Biologicals coadministrada con una dosis de recuerdo de la vacuna DTPa-IPV/Hib (Infanrix-IPV/Hib) en niños prematuros a los 16-18 meses de edad previamente inmunizados en el estudio de primovacunación 10PN-PD-DIT-015 (107737).A phase III open study to assess the safety, reactogenicity and immunogenicity following booster administration of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine, co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) vaccine in preterm born children at 16-18 months of age following primary immunisation in study 10PN-PD-DIT-015 (107737). - 10PN-PD-DIT-016 BST:015

Phase 1

• Conditions: Vacunación de recuerdo frente a Streptococcus pneumoniae en niños prematuros sanos de edad entre 16-18 meses previamente vacunados con 3 dosis de la vacuna antineumocócica decavalente de GSK Biologicals coadministrada con DTPa-HBV-IPV/Hib en el estudio de primovacunación 10PN-PD-DIT-015.

• Registration Number: EUCTR2007-000596-42-ES
• Lead Sponsor: GlaxoSmithKline SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-21
• Study Completion: 2009-03-30
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
A male or female between, and including, 16-18 months of age at the time of the booster vaccination.
A male or female who previously participated in study 10PN-PD-DIT-015 and received three doses of pneumococcal conjugate vaccine.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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. If any apply, the subject must not be included in the study:
•Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2).
•Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 10PN-PD-DIT-015
•History of or intercurrent diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b disease.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
•History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without temperature increase, i.e. oral/axillary/tympanic temperature <37.5°C / rectal temperature <38°C ).
•Febrile illness defined as oral, axillary or tympanic temperature >=37.5°C / rectal temperature >=38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodeficiency.
•Major congenital defects or serious chronic illness.
•Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within three months (90 days) preceding the booster dose of study vaccines or planned administration during the active phase of the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and reactogenicity of a booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib vaccine in preterm born children at 16-18 months of age.;Secondary Objective: To assess one month post booster vaccination the immunogenicity of a booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib vaccine in preterm born children at 16-18 months of age<br>To assess prior to the booster dose the antibody persistence 10 to 12 months after the completion of the 3-dose primary vaccination course with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine.<br>;Primary end point(s): Occurrence of core fever >39°C (rectal temperature) or >38.5°C (oral, axillary or tympanic temperature) within 4 days (day 0-day 3) after booster vaccination.