A Phase 3 interventional study of Pneumococcal vaccine GSK1024850A and DTPa in Infections, Streptococcal, sponsored by GlaxoSmithKline. Completed at 16 sites in Japan. Open to participants aged 90 Days to 118 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-29.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.
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Exclusion Criteria:
Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of Synflorix (10Pn) vaccine, administered intramuscularly on alternating (left/right) sides of the anterolateral thigh and DPT "KAKETSUKEN" Syringe (DTPa) vaccine administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm. Both vaccines were administered at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.
Biological: Pneumococcal vaccine GSK1024850A · Biological: DTPa
Healthy male or female subjects, between 90 and 118 days of age who received 3 doses of the DPT "KAKETSUKEN" Syringe (DTPa) vaccine, administered subcutaneously on alternating (left/right) sides of the distal one third of the upper arm at 3, 4, and 5 months of age, followed by a booster dose at 17-19 months of age.
Biological: DTPa
Intramuscular injection, 4 doses
Also known as: Synflorix
Subcutaneous injection, 4 doses
Also known as: DPT "KAKETSUKEN" Syringe
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)
Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).
Time frame: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations \< 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time frame: Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization)
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time frame: 1 month following primary immunization (at Month 3)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization)
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Time frame: 1 month following primary immunization (at Month 3)
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Concentrations of Antibodies Against Protein D (PD) (Primary Immunization)
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Protein D (PD) (Booster Immunization)
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
Time frame: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
Time frame: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
Time frame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination
Solicited local AEs assessed were pain, redness and swelling. Any = incidence 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.
Time frame: During the 8-day (Days 0-7) after each primary vaccine dose
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination
Solicited local AEs assessed were pain, redness and swelling. Any = incidence 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.
Time frame: During the 8-day (Days 0-7) period following booster vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination
General AEs = drowsiness, fever (axillary ≥ 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = 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 = \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 8-day (Days 0-7) after each primary vaccine dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination
Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 8-day (Days 0-7) period following booster vaccination
Number of Subjects With Unsolicited AEs After Primary Vaccination
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within the 31-day (Days 0-30) post-primary vaccination period, across doses
Number of Subjects With Unsolicited AEs After Booster Vaccination
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within the 31-day (Days 0-30) post booster vaccination period
Number of Subjects With 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.
Time frame: From study start at Month 0 up to study end at Month 15-17
A total of 360 subjects were enrolled in the study. All subjects received at least one vaccination dose.
| Milestone | 10Pn Group | DTPa Group | DTPa + Prevenar Group | DTPa - no Prevenar Group |
|---|---|---|---|---|
| Started | 237 | 123 | 0 | 0 |
| Completed | 233 | 122 | 0 | 0 |
| Not completed | 4 | 1 | 0 | 0 |
| Withdrew: Serious adverse event | 2 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 |
| Withdrew: Migrated/moved from study area | 0 | 1 | 0 | 0 |
| Milestone | 10Pn Group | DTPa Group | DTPa + Prevenar Group | DTPa - no Prevenar Group |
|---|---|---|---|---|
| Started | 228 | 0 | 119 | 1 |
| Completed | 226 | 0 | 119 | 1 |
| Not completed | 2 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 |
| Withdrew: Migrated/moved from study area | 1 | 0 | 0 | 0 |
Concentrations were expressed as geometric mean concentrations (GMCs). Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 microgram per milliliter (µg/mL).
| μg/mL | 10Pn Group | DTPa Group |
|---|---|---|
| Anti-1 | 6.52 (5.85 to 7.26) | 0.04 (0.03 to 0.04) |
| Anti-4 | 6.54 (5.86 to 7.30) | 0.03 (0.03 to 0.03) |
| Anti-5 | 6.54 (5.94 to 7.21) | 0.05 (0.04 to 0.06) |
| Anti-6B | 1.71 (1.43 to 2.05) | 0.03 (0.03 to 0.03) |
| Anti-7F | 6.11 (5.50 to 6.78) | 0.03 (0.03 to 0.04) |
| Anti-9V | 5.42 (4.81 to 6.10) | 0.03 (0.03 to 0.03) |
| Anti-14 | 10.03 (8.80 to 11.43) | 0.07 (0.06 to 0.09) |
| Anti-18C | 16.59 (14.40 to 19.13) | 0.04 (0.03 to 0.04) |
| Anti-19F | 17.39 (15.53 to 19.48) | 0.06 (0.05 to 0.07) |
| Anti-23F | 2.17 (1.83 to 2.57) | 0.04 (0.03 to 0.04) |
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F ELISA, expressed as GMCs, in μg/mL. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations \< 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
| μg/mL | 10Pn Group | DTPa + Prevenar Group | DTPa - no Prevenar Group |
|---|---|---|---|
| Anti-1 PRE | 0.8 (0.69 to 0.92) | 0.04 (0.03 to 0.04) | 0.03 (NA to NA) |
| Anti-1 POST | 7.81 (6.91 to 8.82) | 0.04 (0.04 to 0.05) | 0.24 (NA to NA) |
| Anti-4 PRE | 0.81 (0.7 to 0.93) | 0.85 (0.71 to 1.02) | 0.03 (NA to NA) |
| Anti-4 POST | 12.89 (11.41 to 14.56) | 0.78 (0.64 to 0.94) | 0.03 (NA to NA) |
| Anti-5 PRE | 1.22 (1.05 to 1.41) | 0.08 (0.07 to 0.1) | 0.05 (NA to NA) |
| Anti-5 POST | 8.81 (7.87 to 9.86) | 0.15 (0.12 to 0.17) | 0.03 (NA to NA) |
| Anti-6B PRE | 0.93 (0.79 to 1.1) | 0.34 (0.27 to 0.44) | 0.03 (NA to NA) |
| Anti-6B POST | 3.66 (3.14 to 4.27) | 0.33 (0.25 to 0.42) | 0.03 (NA to NA) |
| Anti-7F PRE | 1.48 (1.32 to 1.65) | 0.05 (0.04 to 0.05) | 0.03 (NA to NA) |
| Anti-7F POST | 10.68 (9.66 to 11.81) | 0.09 (0.08 to 0.11) | 0.03 (NA to NA) |
| Anti-9V PRE | 1.81 (1.61 to 2.03) | 1.01 (0.83 to 1.25) | 0.03 (NA to NA) |
| Anti-9V POST | 12.79 (11.49 to 14.23) | 0.96 (0.79 to 1.17) | 0.03 (NA to NA) |
| Anti-14 PRE | 2.37 (2.04 to 2.74) | 3.17 (2.74 to 3.67) | 0.09 (NA to NA) |
| Anti-14 POST | 15.72 (13.97 to 17.69) | 2.92 (2.53 to 3.38) | 0.16 (NA to NA) |
| Anti-18C PRE | 2.18 (1.89 to 2.51) | 0.94 (0.79 to 1.11) | 0.03 (NA to NA) |
| Anti-18C POST | 34.9 (31.05 to 39.23) | 0.77 (0.65 to 0.92) | 0.03 (NA to NA) |
| Anti-19F PRE | 2.92 (2.5 to 3.41) | 0.51 (0.38 to 0.68) | 0.03 (NA to NA) |
| Anti-19F POST | 28.72 (25.29 to 32.63) | 0.68 (0.51 to 0.91) | 0.03 (NA to NA) |
| Anti-23F PRE | 1.14 (0.93 to 1.39) | 0.55 (0.42 to 0.73) | 0.03 (NA to NA) |
| Anti-23F POST | 7.68 (6.68 to 8.83) | 0.88 (0.7 to 1.12) | 0.03 (NA to NA) |
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
| Titers | 10Pn Group | DTPa Group |
|---|---|---|
| OPSONO-1 | 619.8 (511.9 to 750.6) | 4.8 (4.2 to 5.5) |
| OPSONO-4 | 1184.6 (1043.7 to 1344.5) | 4.1 (3.9 to 4.3) |
| OPSONO-5 | 335.1 (286.4 to 392.1) | 4.2 (4 to 4.5) |
| OPSONO-6B | 1926.6 (1559.6 to 2380) | 5 (4.2 to 5.9) |
| OPSONO-7F | 7905.9 (6854.5 to 9118.6) | 69.5 (43.2 to 111.9) |
| OPSONO-9V | 4063.4 (3565.8 to 4630.4) | 4.9 (4.2 to 5.6) |
| OPSONO-14 | 3392.4 (2962.5 to 3884.8) | 6.5 (5 to 8.5) |
| OPSONO-18C | 893.2 (727.7 to 1096.2) | 4.8 (4 to 5.7) |
| OPSONO-19F | 1254.6 (1031.1 to 1526.5) | 4.4 (4 to 4.9) |
| OPSONO-23F | 4312.1 (3401.5 to 5466.5) | 6 (4.5 to 8) |
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
| Titers | 10Pn Group | DTPa + Prevenar Group | DTPa - no Prevenar Group |
|---|---|---|---|
| OPSONO-1 PRE | 45.9 (34.9 to 60.4) | 4.5 (4 to 5.1) | 4 (NA to NA) |
| OPSONO-1 POST | 2320.7 (1941.8 to 2773.6) | 4.7 (4.1 to 5.5) | 4 (NA to NA) |
| OPSONO-4 PRE | 58.3 (43.6 to 77.9) | 79 (49.3 to 126.7) | 371 (NA to NA) |
| OPSONO-4 POST | 3863.1 (3319.7 to 4495.5) | 69.3 (43.1 to 111.5) | 493 (NA to NA) |
| OPSONO-5 PRE | 22.9 (19.1 to 27.6) | 4.2 (3.9 to 4.5) | 4 (NA to NA) |
| OPSONO-5 POST | 686.7 (583.8 to 807.9) | 4.7 (4.1 to 5.3) | 4 (NA to NA) |
| OPSONO-6B PRE | 191.2 (141.9 to 257.5) | 118.5 (66.3 to 211.7) | 4 (NA to NA) |
| OPSONO-6B POST | 1682.9 (1379.1 to 2053.7) | 119 (68.5 to 206.9) | 4 (NA to NA) |
| OPSONO-7F PRE | 2244.8 (1921.9 to 2621.9) | 1014.7 (743.8 to 1384.1) | 588 (NA to NA) |
| OPSONO-7F POST | 14144.3 (12109.3 to 16521.4) | 1165.6 (855.7 to 1587.8) | 1278 (NA to NA) |
| OPSONO-9V PRE | 520 (437.3 to 618.5) | 1081.6 (803.3 to 1456.4) | 4595 (NA to NA) |
| OPSONO-9V POST | 4693.7 (4099 to 5374.6) | 958.8 (680 to 1351.8) | 367 (NA to NA) |
| OPSONO-14 PRE | 673.1 (573.1 to 790.6) | 826.7 (669.3 to 1021) | 4 (NA to NA) |
| OPSONO-14 POST | 6209 (5299.3 to 7274.8) | 819.1 (651.4 to 1030.1) | 4 (NA to NA) |
| OPSONO-18C PRE | 26.3 (21.1 to 32.6) | 11.5 (8.2 to 16) | 4 (NA to NA) |
| OPSONO-18C POST | 2181 (1900.1 to 2503.4) | 12.7 (9.1 to 17.7) | 4 (NA to NA) |
| OPSONO-19F PRE | 83.4 (64.7 to 107.6) | 21.1 (13.5 to 32.9) | 4 (NA to NA) |
| OPSONO-19F POST | 3496.3 (2938.8 to 4159.6) | 20.9 (13.7 to 31.8) | 191 (NA to NA) |
| OPSONO-23F PRE | 600.5 (417.6 to 863.4) | 1048 (561.5 to 1956.1) | 4 (NA to NA) |
| OPSONO-23F POST | 7057.2 (5896.6 to 8446.1) | 1758.3 (949.4 to 3256.5) | 4 (NA to NA) |
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
| μg/mL | 10Pn Group | DTPa Group |
|---|---|---|
| Anti-6A | 0.41 (0.34 to 0.49) | 0.04 (0.03 to 0.04) |
| Anti-19A | 0.48 (0.4 to 0.57) | 0.04 (0.04 to 0.05) |
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations. Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A. The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. Antibody concentrations \< 0.05 g/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
| μg/mL | 10Pn Group | DTPa + Prevenar Group | DTPa - no Prevenar Group |
|---|---|---|---|
| Anti-6A PRE | 0.61 (0.5 to 0.75) | 0.19 (0.14 to 0.26) | 0.03 (NA to NA) |
| Anti-6A POST | 2.72 (2.24 to 3.3) | 0.21 (0.16 to 0.27) | 0.03 (NA to NA) |
| Anti-19A PRE | 0.57 (0.45 to 0.71) | 0.12 (0.09 to 0.16) | 0.03 (NA to NA) |
| Anti-19A POST | 5.16 (4.18 to 6.37) | 0.15 (0.11 to 0.2) | 0.03 (NA to NA) |
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
| Titers | 10Pn Group | DTPa Group |
|---|---|---|
| Opsono-6A | 339.6 (253.8 to 454.4) | 4.6 (4.1 to 5.1) |
| Opsono-19A | 34.3 (26.2 to 44.9) | 4.3 (4 to 4.6) |
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. Administration of catch-up pneumococcal vaccination with a licensed product other than Synflorix was allowed in the DTPa Group at least 7 days before DTPa vaccine booster dose. Thus, for this booster phase analysis, the DTPa Group was further split in DTPa + Prevenar Group and DTPa - no Prevenar Group.
| Titers | 10Pn Group | DTPa + Prevenar Group | DTPa - no Prevenar Group |
|---|---|---|---|
| OPSONO-6A PRE | 138.5 (103.3 to 185.7) | 60.4 (35.2 to 103.7) | 4 (NA to NA) |
| OPSONO-6A POST | 767.9 (593.1 to 994.1) | 103.3 (60.4 to 176.6) | 4 (NA to NA) |
| OPSONO-19A PRE | 13.1 (10.1 to 16.9) | 7.7 (5.5 to 10.6) | 4 (NA to NA) |
| OPSONO-19A POST | 431.4 (330.9 to 562.4) | 8.6 (6 to 12.2) | 4 (NA to NA) |
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
| EL.U/mL | 10Pn Group | DTPa Group |
|---|---|---|
| Concentrations of Antibodies Against Protein D (PD) (Primary Immunization) | 2548.6 (2315.1 to 2805.7) | 87.9 (75.8 to 102) |
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
| EL.U/mL | 10Pn Group | DTPa Booster Group |
|---|---|---|
| Anti-PD PRE | 702.6 (601 to 821.5) | 82.3 (71.7 to 94.5) |
| Anti-PD POST | 2916.9 (2552.9 to 3332.7) | 86.9 (75.1 to 100.4) |
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
| IU/mL | 10Pn Group | DTPa Group |
|---|---|---|
| Anti-DT | 5.363 (5.002 to 5.749) | 3.829 (3.464 to 4.233) |
| Anti-TT | 5.427 (4.94 to 5.962) | 3.626 (3.174 to 4.143) |
Concentrations of antibodies are presented as geometric mean concentrations expressed as International units per millilitre (IU/mL). Seroprotection status, defined as Anti-DT or Anti-TT antibody concentration equal to or greater than 0.1 IU/mL.
| IU/mL | 10Pn Group | DTPa Booster Group |
|---|---|---|
| Anti-DT PRE | 0.615 (0.556 to 0.679) | 0.717 (0.618 to 0.833) |
| Anti-DT POST | 15.977 (14.573 to 17.515) | 10.814 (9.684 to 12.075) |
| Anti-TT PRE | 2.043 (1.677 to 2.489) | 1.352 (1.038 to 1.762) |
| Anti-TT POST | 11.057 (9.949 to 12.287) | 6.278 (5.334 to 7.389) |
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
| EL.U/mL | 10Pn Group | DTPa Group |
|---|---|---|
| Anti-PT | 123.2 (115.2 to 131.7) | 133.1 (119.5 to 148.3) |
| Anti-FHA | 308.6 (284.8 to 334.3) | 365 (327.9 to 406.2) |
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per millilitre (EL.U/mL). Seropositivity was defined as an antibody concentration equal to or greater than 5 EL.U/mL
| EL.U/mL | 10Pn Group | DTPa Booster Group |
|---|---|---|
| Anti-PT PRE | 14.9 (13.2 to 16.8) | 18.1 (15.1 to 21.7) |
| Anti-PT POST | 158.4 (143.7 to 174.7) | 204 (176.7 to 235.6) |
| Anti-FHA PRE | 37.9 (33.3 to 43.1) | 48.4 (40.6 to 57.8) |
| Anti-FHA POST | 460.6 (421.2 to 503.7) | 584.5 (512.6 to 666.6) |
Solicited local AEs assessed were pain, redness and swelling. Any = incidence 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.
| Participants | 10Pn Group | DTPa Group |
|---|---|---|
| Any pain Dose 1 | 83 | 19 |
| Grade 3 pain Dose 1 | 1 | 0 |
| Any redness Dose 1 | 182 | 71 |
| Grade 3 Redness Dose 1 | 10 | 0 |
| Any swelling Dose 1 | 126 | 33 |
| Grade 3 Swelling Dose 1 | 16 | 0 |
| Any pain Dose 2 | 74 | 26 |
| Grade 3 pain Dose 2 | 0 | 0 |
| Any redness Dose 2 | 200 | 96 |
| Grade 3 Redness Dose 2 | 25 | 4 |
| Any swelling Dose 2 | 160 | 75 |
| Grade 3 Swelling Dose 2 | 26 | 4 |
| Any pain Dose 3 | 63 | 23 |
| Grade 3 pain Dose 3 | 1 | 0 |
| Any redness Dose 3 | 178 | 84 |
| Grade 3 Redness Dose 3 | 24 | 0 |
| Any swelling Dose 3 | 142 | 65 |
| Grade 3 Swelling Dose 3 | 27 | 1 |
Solicited local AEs assessed were pain, redness and swelling. Any = incidence 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.
| Subjects | 10Pn Group | DTPa Booster Group |
|---|---|---|
| Any pain | 134 | 47 |
| Grade 3 pain | 12 | 0 |
| Any redness | 197 | 102 |
| Redness > 30 mm | 72 | 20 |
| Any swelling | 180 | 90 |
| Swelling > 30 mm | 65 | 18 |
General AEs = drowsiness, fever (axillary ≥ 37.5 degrees Celsius), irritabilityand loss of appetite, vomiting. Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = 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 = \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
| Participants | 10Pn Group | DTPa Group |
|---|---|---|
| Any drowsiness Dose 1 | 67 | 24 |
| Grade 3 drowsiness Dose 1 | 3 | 0 |
| Related drowsiness Dose 1 | 24 | 6 |
| Any Fever Dose 1 | 61 | 20 |
| Grade 3 Fever Dose 1 | 1 | 0 |
| Related fever Dose 1 | 20 | 5 |
| Any irritability Dose 1 | 100 | 43 |
| Grade 3 irritability Dose 1 | 6 | 3 |
| Related irritability Dose 1 | 40 | 12 |
| Any loss of appetite Dose 1 | 32 | 12 |
| Grade 3 loss of appetite Dose 1 | 0 | 0 |
| Related loss of appetite Dose 1 | 4 | 1 |
| Any drowsiness Dose 2 | 67 | 34 |
| Grade 3 drowsiness Dose 2 | 2 | 0 |
| Related drowsiness Dose 2 | 26 | 9 |
| Any Fever Dose 2 | 65 | 22 |
| Grade 3 Fever Dose 2 | 0 | 0 |
| Related fever Dose 2 | 31 | 7 |
| Any irritability Dose 2 | 88 | 45 |
| Grade 3 irritability Dose 2 | 4 | 0 |
| Related irritability Dose 2 | 30 | 12 |
| Any loss of appetite Dose 2 | 27 | 7 |
| Grade 3 loss of appetite Dose 2 | 0 | 0 |
| Related loss of appetite Dose 2 | 7 | 2 |
| Any drowsiness Dose 3 | 41 | 25 |
| Grade 3 drowsiness Dose 3 | 0 | 0 |
| Related drowsiness Dose 3 | 15 | 10 |
| Any Fever Dose 3 | 51 | 21 |
| Grade 3 Fever Dose 3 | 2 | 0 |
| Related fever Dose 3 | 21 | 2 |
| Any irritability Dose 3 | 80 | 31 |
| Grade 3 irritability Dose 3 | 3 | 0 |
| Related irritability Dose 3 | 31 | 10 |
| Any loss of appetite Dose 3 | 25 | 7 |
| Grade 3 loss of appetite Dose 3 | 0 | 0 |
| Related loss of appetite Dose 3 | 5 | 0 |
Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature \> 39.5°C Related = symptom assessed by the investigator as related to the vaccination.
| Subjects | 10Pn Group | DTPa Booster Group |
|---|---|---|
| Any drowsiness | 69 | 30 |
| Grade 3 drowsiness | 3 | 3 |
| Related drowsiness | 19 | 7 |
| Fever >= 37.5°C | 90 | 24 |
| Fever > 39.5°C | 6 | 0 |
| Related fever | 41 | 11 |
| Any irritability | 90 | 35 |
| Grade 3 irritability | 8 | 2 |
| Related irritability | 36 | 10 |
| Any loss of appetite | 48 | 17 |
| Grade 3 loss of appetite | 4 | 1 |
| Related loss of appetite | 12 | 2 |
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
| Subjects | 10Pn Group | DTPa Group |
|---|---|---|
| Number of Subjects With Unsolicited AEs After Primary Vaccination | 193 | 97 |
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
| Subjects | 10Pn Group | DTPa Booster Group |
|---|---|---|
| Number of Subjects With Unsolicited AEs After Booster Vaccination | 132 | 66 |
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.
| Participants | 10Pn Group | DTPa Group |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 28 | 19 |
Collected over Solicited AEs: within 8 days (Day 0 - Day 7) after any vaccine dose; Unsolicited AEs: within 31 days (Day 0 - Day 30) after any vaccine dose. SAEs: from Dose 1 up to Study End (Day 0 to Month 15-17). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10Pn Group | 1/237 (0.4%) | 28/237 (11.8%) | 236/237 (99.6%) |
| DTPa Group | 0/123 (0%) | 19/123 (15.4%) | 122/123 (99.2%) |
| Event | 10Pn Group | DTPa Group |
|---|---|---|
| PneumoniaInfections and infestations | 6/237 | 1/123 |
| BronchitisInfections and infestations | 3/237 | 3/123 |
| Croup infectiousInfections and infestations | 0/237 | 3/123 |
| Respiratory syncytial virus infectionInfections and infestations | 5/237 | 1/123 |
| Urinary tract infectionInfections and infestations | 0/237 | 2/123 |
| GastroenteritisInfections and infestations | 3/237 | 0/123 |
| Gastroenteritis rotavirusInfections and infestations | 2/237 | 1/123 |
| Otitis mediaInfections and infestations | 2/237 | 0/123 |
| Upper respiratory tract infectionInfections and infestations | 2/237 | 0/123 |
| Febrile convulsionNervous system disorders | 2/237 | 0/123 |
| Event | 10Pn Group | DTPa Group |
|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 230/237 | 114/123 |
| SwellingGeneral disorders | 214/237 | 113/123 |
| IrritabilityPsychiatric disorders | 177/237 | 81/123 |
| PainGeneral disorders | 167/237 | 62/123 |
| PyrexiaGeneral disorders | 156/237 | 64/123 |
| SomnolenceNervous system disorders | 131/237 | 63/123 |
| Decreased appetiteMetabolism and nutrition disorders | 91/237 | 37/123 |
| Upper respiratory tract infectionInfections and infestations | 85/237 | 43/123 |
| Injection site indurationGeneral disorders | 56/237 | 23/123 |
| EczemaSkin and subcutaneous tissue disorders | 49/237 | 25/123 |
| Age, Continuous(Weeks) | 10Pn Group | DTPa Group | Total |
|---|---|---|---|
| Mean | 13.6 ± 1.02 | 13.5 ± 1.1 | 13.57 ± 1.05 |
| Sex: Female, Male(Participants) | 10Pn Group | DTPa Group | Total |
|---|---|---|---|
| Female | 117 | 59 | 176 |
| Male | 120 | 64 | 184 |
Plan to share: Yes — IPD for this study is available via the Clinical Study Data Request site (click on the link provided below)
Supporting information: Study protocol, Sap, Icf, Csr
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