Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria

Kokeellinen: Synflorix/Infanrix primed Group

Subjects previously primed with the Synflorix™ vaccine in the primary study 110521 (NCT00678301) received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Biologinen: Pneumokokkirokote GSK1024850A

Injektio lihakseen, 1 tai 2 annosta

Biologinen: InfanrixTM

Intramuscular injection, 1dose

Muut nimet:

• DTPa

Kokeellinen: Synflorix/Infanrix unprimed Group

Unprimed subjects from the primary study 110521 (NCT00678301), not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Biologinen: Pneumokokkirokote GSK1024850A

Injektio lihakseen, 1 tai 2 annosta

Biologinen: InfanrixTM

Intramuscular injection, 1dose

Muut nimet:

• DTPa

Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited).

Grade 3 symptom = severe symptom that prevented normal activity.

Solicited local symptoms assessed were pain, redness and swelling.

Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite.

Unsolicited AEs = Any AE reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.

Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).

Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.

Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.

Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).

The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.

Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.

Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8.

Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes.

Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A.

Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8.

Concentration of Antibodies Against Protein D (PD).

Anti-PD antibodies were determined using an ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EL.U/mL).

Number of Subjects Reporting Any and Grade 3 Solicited Local AEs.

Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events was actively solicited from the subject or an observer during a specified post-vaccination follow-up period.

Solicited local symptoms assessed were pain, redness and swelling.

Any = occurrence of any local symptom regardless of intensity grade.

Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs.

Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).

Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.

Related = solicited symptom assessed by the investigator as causally related to study vaccination.

Number of Subjects Reporting Unsolicited AEs.

Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Number of Subjects Reporting Serious Adverse Events (SAEs).

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.