A phase III, open, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar when given as a booster dose between 11-18 months of age in children previously vaccinated in the primary study 10PN-PD-DIT-011 (107005) with either GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar. - 10PN-PD-DIT-017 BST 011

GlaxoSmithKline Biologicals0 sites1,437 target enrollmentJune 26, 2007

ConditionsBooster vaccination against Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b in healthy infants 11 to18 months of age who were previously primed with three doses of pneumococcal conjugate vaccine co-administered with three doses of DTPa-combined and MenC or Hib-MenC vaccines.

DrugsMenitorix Prevenar Meningitec Neisvac Infanrix penta

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Booster vaccination against Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b in healthy infants 11 to18 months of age who were previously primed with three doses of pneumococcal conjugate vaccine co-administered with three doses of DTPa-combined and MenC or Hib-MenC vaccines.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 1437
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 26, 2007

End Date

June 14, 2008

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•All subjects must satisfy the following criteria at study entry:
•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, 11\-18 months of age at the time of the booster vaccination.
•A male or female who previously participated in study 10PN\-PD\-DIT\-011 (107005\) 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

Exclusion Criteria

•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 one month (30 days) preceding the booster dose of study vaccines, or planned use during the entire study period (active phase and 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 vaccines. (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 one month (30 days) before the booster dose of study vaccines (Visit 1\) and up to the follow\-up visit (Visit 2\).
•Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib\-MenC vaccines other than the study vaccines from study 10PN\-PD\-DIT\-011 (107005\).
•History of , or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C 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 a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea or mild upper respiratory infections with or without low\-grade febrile illness, i.e. oral/axillary/tympanic temperature \<37\.5°C / rectal temperature \<38\.0°C).