Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

Phase 3

Completed

Conditions: Infections, Streptococcal
Streptococcus Pneumoniae

Interventions: Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)
Biological: Pneumococcal conjugate vaccine GSK 1024850A

Registration Number: NCT00907777

Lead Sponsor: GlaxoSmithKline

Brief Summary: The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 4. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 52

Inclusion Criteria

Male or female between, and including, 46-50 months of age at the time of vaccination.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
Written informed consent obtained from both parents/guardians of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
Administration of any pneumococcal vaccine since the end of study NCT00333450.
Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical
History of any neurologic disorders or seizures
Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
History of hypotonic-hyporesponsive episode after any previous vaccination.
Major congenital defects or serious chronic illness.
History of invasive pneumococcal diseases.
Acute disease at the time of vaccination
Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prev Group	Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)	Subjects receiving Prevenar™ vaccine.
Pn Group	Pneumococcal conjugate vaccine GSK 1024850A	Subjects receiving GSK 1024850A vaccine.

Primary Outcome Measures

Name	Time	Method
Vaccine Pneumococcal Serotype Antibody Concentrations	Before (PRE) and one month after (POST) the additional dose	The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Secondary Outcome Measures

Name	Time	Method
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes	Before (PRE) and one month after (POST) the additional dose	The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms	During the 8-day (Days 0-7) post-additional dose	Solicited local symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Cross-reactive Pneumococcal Serotype Antibody Concentrations	Before (PRE) and one month after (POST) the additional dose	The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	During the 8-day (Days 0-7) post-additional dose	Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)	Within 31 days (Day 0-30) post-additional vaccination	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes	Before (PRE) and one month after (POST) the additional dose	The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Anti-protein D Antibody Concentrations	Before (PRE) and one month after (POST) the additional dose	The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Number of Subjects With Serious Adverse Events (SAEs)	Throughout the entire study period (approximately 1 month per subject)	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.