Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

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Dinah Henderson
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1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: (SPNG-001) Title: A study to evaluate GSK Biologicals candidate formulations of pneumococcal vaccines in young adults. Rationale: The aim of this study was to evaluate the safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals investigational pneumococcal vaccines containing Streptococcus pneumoniae proteins alone or in combination with the 10-valent conjugate vaccines in comparison to Pneumovax 23, in a healthy young adult population. Pneumococcal investigational vaccine (PV): GSK Biologicals investigational pneumococcal vaccine. Pneumovax 23 TM vaccine: MSD Sanofi Pasteur 23-valent polysaccharide pneumococcal vaccine (23PPV) Phase: I Study Period: 30 June 2008 to 15 January 2009 Study Design: Observer-blind, randomized and controlled study with 7 parallel groups. Centres: 1 centre in Belgium. Indication: Pneumococcal vaccine in young adult subjects aged between 18 years old and 40 years old, in good general health. Treatment: The study groups were as follows: PV1 : subjects receiving PV formulation 1 PV2 : subjects receiving PV formulation 2 PV3 : subjects receiving PV formulation 3 PV4 : subjects receiving PV formulation 4 PV5 : subjects receiving PV formulation 5 PV6 : subjects receiving PV formulation 6 23PPV : subjects receiving 23PPV All vaccines were administered by intramuscular injection into the deltoid region of the non-dominant arm. Objectives: To evaluate the safety profile of the investigational pneumococcal vaccines when administered intramuscularly in healthy adults as a single dose at Day 0 and again at 2 months (Day 0 and Day 60). Primary Outcome/Efficacy Variable: Safety Occurrence of any vaccine related and grade 3 solicited local and general symptoms during a 7-day follow up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose. Occurrence of any vaccine related and grade 3 unsolicited adverse events (AEs) during a 31-day follow up period (i.e. day of vaccination and 30 subsequent days) after each vaccine dose. Occurrence of any vaccine related serious adverse events (SAE) occurring from Day 0 to study conclusion (Day 90). Occurrence of any grade 3 haematological, biochemical, or urinary abnormalities, at 1 and 7 days after each vaccine dose.

2 Secondary Outcome/Efficacy Variables: Safety Occurrence of any solicited local and general symptoms during a 7-day follow up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose. Occurrence of any unsolicited AEs during a 31-day follow up period (i.e. day of vaccination and 30 subsequent days) after each vaccine dose. Occurrence of any haematological, biochemical, or urinary abnormalities at 1 and 7 days after each vaccine dose. Immunogenicity Anti-pneumococcal and anti-non typable Haemophilus influenzae (anti-nthi) investigational vaccine antigens at Days 0, 30 and 90. Criteria for assessment: - Anti-pneumolysin toxoid (Anti-dPly), anti-pneumococcal histidine triad protein D (anti-phtd) and anti-protein D (anti-pd) antibody concentrations (measured by ELISA or Multiplex assays), prior to first vaccination and 30 days (1 month) after each vaccination. -Anti-Polysaccharide (anti-ps) opsonophagocytic activity (OPA) titres, prior to first vaccination and 30 days (1 month) after each vaccination. Statistical Methods: The analyses were performed on the Total Vaccinated cohort and the ATP (According to Protocol) cohort for immunogenicity. - The Total Vaccinated cohort included all subjects with at least one study vaccine administration documented. - The ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom pre and post vaccination results were available for at least one assay. Analysis of Immunogenicity: The analysis of immunogenicity was performed on the ATP cohort for immunogenicity. Antibody geometric mean concentrations or titres (GMCs or GMTs) and seropositivity rates were calculated with their 95% confidence Intervals (CIs) for each treatment group, each time point and each antibody assessed. Analysis of safety: The analysis of safety was performed on the Total Vaccinated cohort. The percentage of subjects with each individual solicited local and general symptoms within the 7-day (Days 0-6) follow-up period after vaccination was summarized with its exact 95% CIs for each group per dose and across doses. The same tabulation was performed for grade 3 symptoms and for general symptoms assessed by the investigators as causally related to vaccination. All solicited local symptoms were assessed as causally related to the study vaccination. The percentage of subjects with unsolicited AEs within the 31-day (Days 0-30) follow-up period after vaccination were tabulated according to the Medical Dictionary for Regulatory Activities (MedDRA) preferred term. The same tabulation was performed for grade 3 AEs and for AEs assessed by the investigators as having a causal relationship to vaccination. The occurrence of SAEs and that of SAEs assessed by the investigators as causally related to study vaccination reported during the study period (from Day 0 to Day 90) were tabulated according to the MedDRA preferred term. For each haematology, biochemistry and urine parameter, the grading was summarized per study group, at 1 and 7 days after each vaccine dose. Study Population: Healthy male or female between the ages of years at the time of first vaccination. If the subject was female of child-bearing potential, she had to agree to use adequate contraception and not become pregnant for the duration of the study. Written informed consent was obtained from all the subjects before enrolment in the study. Number of subjects PV1 PV2 PV3 PV4 PV5 PV6 23PPV Planned, N Randomized, N (Total Vaccinated cohort) Completed, n (%) 10 (83.3) 21 (87.5) 23 (95.8) 24 (100) 24 (100) 21 (87.5) 23 (95.8) Total Number Subjects Withdrawn, 2 (16.7) 3 (12.5) 1 (4.2) 0 (0.0) 0 (0.0) 3 (12.5) 1 (4.2) n (%) Withdrawn due to Adverse Events, 0 (0.0) 2 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)

3 n (%) Withdrawn due to Lack of Efficacy, Not Not Not Not Not Not Not n (%) applicable applicable applicable applicable applicable applicable applicable Withdrawn for other reasons, n (%) 2 (16.7) 1 (4.2) 1 (4.2) 0 (0.0) 0 (0.0) 3 (12.5) 1 (4.2) Demographics PV1 PV2 PV3 PV4 PV5 PV6 23PPV N (Total Vaccinated cohort) Females : Males 4:8 14:10 16:8 14:10 14:10 15:9 15:9 Mean Age, years (SD) 26.3 (5.74) 25.8 (5.39) 26.3 (5.17) 23.3 (3.87) 25.0 (6.53) 23.0 (5.09) 26.3 (6.90) White - Caucasian / European heritage, n (%) 11 (91.7) 24 (100) 24 (100) 24 (100) 24 (100) 24 (100) 24 (100) Primary Efficacy Results: Number (%) of subjects reporting solicited local symptoms reported during the 7-day (Days 0-6) post-vaccination period following each dose and across doses (Total Vaccinated cohort) PV1 PV2 PV3 95 % CI 95 % CI 95 % CI Symptom Intensity N n % LL UL N n % LL UL N n % LL UL Dose 1 Pain Any Grade 3* Redness Any > 50 mm* Swelling Any > 50 mm* Dose 2 Pain Any Grade 3* Redness Any > 50 mm* Swelling Any > 50 mm* Across Doses Pain Any Grade 3* Redness Any > 50 mm* Swelling Any > 50 mm* PV4 PV5 PV6 95 % CI 95 % CI 95 % CI Symptom Intensity N n % LL UL N n % LL UL N n % LL UL Dose 1 Pain Any Grade 3* Redness Any > 50 mm* Swelling Any > 50 mm* Dose 2 Pain Any Grade 3* Redness Any

4 > 50 mm* Swelling Any > 50 mm* Across Doses Pain Any Grade 3* Redness Any > 50 mm* Swelling Any > 50 mm* PPV 95 % CI Symptom Intensity N n % LL UL Dose 1 Pain Any Grade 3* Redness Any > 50 mm* Swelling Any > 50 mm* Dose 2 Pain Any Grade 3* Redness Any > 50 mm* Swelling Any > 50 mm* Across Doses Pain Any Grade 3* Redness Any > 50 mm* Swelling Any > 50 mm* N = number of subjects with at least one documented dose n (%) = number(percentage) of subjects reporting at least once the symptom 95% CI = Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = occurrence of any local symptom regardless of intensity grade Grade 3 pain = pain that prevented normal activity *Primary outcome variable Primary Efficacy Results: Number (%) of subjects reporting solicited general symptoms reported during the 7-day (Days 0-6) post-vaccination period following each dose and across doses (Total Vaccinated cohort) PV1 PV2 PV3 95 % CI 95 % CI 95 % CI Symptom Intensity/ Relationship N n % LL UL N n % LL UL N n % LL UL Dose 1 Fatigue Any Grade 3* Related* Gastrointestinal Any Grade 3*

5 Related* Headache Any Grade 3* Related* Malaise Any Grade 3* Related* Myalgia Any Grade 3* Related* Temperature (Orally) 37.5 C > 39.5 C* Related* Dose 2 Fatigue Any Grade 3* Related* Gastrointestinal Any Grade 3* Related* Headache Any Grade 3* Related* Malaise Any Grade 3* Related* Myalgia Any Grade 3* Related* Temperature (Orally) 37.5 C >39.5 C* Related* Across Doses Fatigue Any Grade 3* Related* Gastrointestinal Any Grade 3* Related* Headache Any Grade 3* Related* Malaise Any Grade 3* Related* Myalgia Any Grade 3* Related* Temperature (Orally) Symptom 37.5 C >39.5 C* Related* PV4 PV5 PV6 95 % CI 95 % CI 95 % CI Intensity/ Relationship N n % LL UL N n % LL UL N n % LL UL

6 Dose 1 Fatigue Any Grade 3* Related* Gastrointestinal Any Grade 3* Related* Headache Any Grade 3* Related* Malaise Any Grade 3* Related* Myalgia Any Grade 3* Related* Temperature (Orally) 37.5 C >39.5 C* Related* Dose 2 Fatigue Any Grade 3* Related* Gastrointestinal Any Grade 3* Related* Headache Any Grade 3* Related* Malaise Any Grade 3* Related* Myalgia Any Grade 3* Related* Temperature (Orally) 37.5 C >39.5 C* Related* Across Doses Fatigue Any Grade 3* Related* Gastrointestinal Any Grade 3* Related* Headache Any Grade 3* Related* Malaise Any Grade 3* Related* Myalgia Any Grade 3* Related* Temperature/(Or ally) 37.5 C >39.5 C*

7 Related* PPV 95 % CI Symptom Intensity/Relationship N n % LL UL Dose 1 Fatigue Any Grade 3* Related* Gastrointestinal Any Grade 3* Related Headache Any Grade 3* Related* Malaise Any Grade 3* Related* Myalgia Any Grade 3* Related* Temperature/(Orally) 37.5 C >39.5 C* Related* Dose 2 Fatigue Any Grade 3* Related* Gastrointestinal Any Grade 3* Related* Headache Any Grade 3* Related* Malaise Any Grade 3* Related* Myalgia Any Grade 3* Related* Temperature/(Orally) 37.5 C >39.5 C* Related* Across Doses Fatigue Any Grade 3* Related* Gastrointestinal Any Grade 3* Related* Headache Any Grade 3** Related* Malaise All Grade 3* Related* Myalgia Any

8 Grade 3* Related* Temperature/(Orally) 37.5 C >39.5 C* Related* N= number of subjects with at least one documented dose n (%)= number(percentage) of subjects reporting at least once the symptom 95%CI= Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = occurrence of any general symptom regardless of the intensity grade or relationship to vaccination Grade 3 = symptoms that prevented normal activity Related = general symptoms assessed by the investigator to be casually related to the study vaccination *Primary outcome variable Primary Efficacy Results: Number (%) of subjects with haematology and biochemistry abnormalities during the postvaccination period (Total Vaccinated cohort) Grade 1 Grade 2 Grade 3* Grade 4 Laboratory test Timing N n % n % n % n % Alanine Aminotransferase PV1 Day Day Day PV2 Day Day Day Day PV3 Day Day Day Day PV4 Day Day PV5 Day Day PV6 Day Aspartate aminotransferse PV1 Day Day Day PV2 Day Day PV4 Day Day Day PV6 Day Cholesterol PV1 Day Day Day Day PV2 Day Day Day PV3 Day Day Day Day PV4 Day Day Day Day

9 PV5 Day Day Day Day PV6 Day Day Day Day PPV Day Day Day Day Creatine Phosphokinase PV1 Day Day Day Day PV2 Day Day Day Day PV3 Day Day Day Day PV4 Day Day Day Day PV5 Day Day Day Day PV6 Day Day Day PPV Day Day Day Day Eosinophils PV3 Day PV5 Day PV6 Day Haemoglobin PV1 Day Day Day PV2 Day Day Day PV3 Day Day Day Day PV4 Day Day PV5 Day Day

10 Day PV6 Day Day Day Day PPV Day Day Day Day Haemoglobin decrease PV1 Day Day Day Day PV2 Day Day Day Day PV3 Day Day Day Day PV4 Day Day Day Day PV5 Day Day Day Day PV6 Day Day Day Day PPV Day Day Day Day Lactate dehydrogenase PV3 Day PV4 Day Day Day PV5 Day Day PV6 Day Day Day Lymphocytes PV4 Day PV5 Day Day PV6 Day Neutrophils PV1 Day Day Day Day PV2 Day Day

11 Day PV3 Day Day Day PV4 Day Day Day PV5 Day Day PPV Day Day Day Platelets PV1 Day Day Day Day PV3 Day Red blood cells (urine) PV1 Day Day Day Day PV2 Day Day Day Day PV3 Day Day Day Day PV4 Day Day Day Day PV5 Day Day Day Day PV6 Day Day Day Day PPV Day Day Day Day Reticulocyte count PV1 Day PV3 Day Day Day PV5 Day White blood cells decrease PV1 Day Day Day Day PV2 Day PV3 Day

12 Day PV5 Day PPV Day White blood cells increase PV2 Day Day PV3 Day Day PV4 Day PV5 Day Day PV6 Day Day PPV Day Day Overall parameters PV1 Day Day Day Day PV2 Day Day Day Day PV3 Day Day Day Day PV4 Day Day Day Day PV5 Day Day Day Day PV6 Day Day Day Day PPV Day Day Day Day N = number of subjects with laboratory results at the specified time point n(%) = number (percentage) of subjects with a maximum grade in the given category FDA Toxicity Grading Scale for biochemical parameters: Liver Function Tests-ALT, AST increase by factor Mild (Grade 1) Moderate (Grade 2) Severe (Grade 3) Potentially Life Threatening (Grade 4)** x ULN x ULN x ULN > 10 x ULN Cholesterol >226 - Creatinine mg/dl >2.5 or requires dialysis Eosinophilscell/mm >5000 Hypereosinophilic

13 Hemoglobin <8.0 (Female)-gm/dL Hemoglobin Any decrease >5.0 (Female) change from baseline valuegm/dl Hemoglobin (Male) <8.5 gm/dl Hemoglobin (Male) Any decrease >5.0 change from baseline valuegm/dl Lymphocytes 750-1, <250 Decrease-cell/mm 3 Neutrophils 1,500-2,000 1,000-1, <500 Decrease-cell/mm 3 Platelets Decreasecell/mm 125, , , ,000 25,000-99,000 <25,000 3 WBC Increasecell/mm 10,800-15,000 15,001-20,000 20,001-25,000 >25,000 3 WBC Decreasecell/mm 2,500-3,500 1,500-2,499 1,000-1,499 <1,000 3 ULN = upper limit normal Grades for study required tests not included within the FDA Toxicity Grading Scale: Normal Grade 1 Grade 2 Grade 3 Grade 4 (SAE) LDH Units/L x ULN x ULN 2-3 x ULN >3 x ULN Reticulocytes x ULN x ULN 2-3 x ULN >3 x ULN index- Male Reticulocytes index- Female x ULN x ULN 2-3 x ULN >3 x ULN ULN = upper limit normal *Primary outcome variable Primary Efficacy Results: Number (%) of subjects with urine abnormalities during the post-vaccination period (Total Vaccinated cohort) Grade 1 Grade 2 Grade 3* Grade 4 Laboratory test** Timing N n % n % n % n % Blood (Erythrocytes or Hemoglobulin) PV1 Day Day Day PV2 Day Day Day PV3 Day Day Day PV4 Day Day Day Day PV5 Day Day Day Day PV6 Day Day

14 Day Day PPV Day Day Day Day Overall parameters PV1 Day Day Day PV2 Day Day Day PV3 Day Day Day PV4 Day Day Day Day PV5 Day Day Day Day PV6 Day Day Day Day PPV Day Day Day Day N= number of subjects with laboratory results at the specified time point n(%)=number(percentage) of subjects with a maximum grade in the given category *Primary outcome variable **Urine parameters were assessed by Reagent-strip testing Primary Efficacy Results: Please refer to the safety section of this CTRS for the results of unsolicited AEs and SAEs Secondary Outcome Variables: Seropositivity rates and GMCs for Anti-PhtD antibodies (ATP cohort for immunogenicity) 391 LU/mL GMC (LU/mL) 95% CI 95% CI Antibody Timing N n % LL UL value LL UL Anti-PhtD PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90)

15 PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) Seropositivity rate = anti-phtd antibody concentration 391 LU/mL GMC = geometric mean antibody concentration N = number of subjects with available results n(%) = number(percentage) of subjects with concentration within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PRE = Blood sample before dose 1 PI(D30) = Blood sample 30 days after dose 1 PII(D90) = Blood sample 30 days after dose 2 Secondary Outcome Variables: Seropositivity rates and GMCs for Anti-dPly antibodies (ATP cohort for immunogenicity) 599 LU/mL GMC (LU/mL) 95% CI 95% CI Antibody Timing N n % LL UL value LL UL Anti-dPly PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) Seropositivity rate = anti-dply antibody concentration 599 LU/mL GMC = geometric mean antibody concentration N = number of subjects with available results n(%) = number (percentage) of subjects with concentration within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PRE = Blood sample before dose 1 PI(D30) = Blood sample 30 days after dose 1 PII(D90) = Blood sample 30 days after dose 2 Secondary Outcome Variables: Seropositivity rates and GMCs for Anti-PD antibodies measured by multiplex assay (ATP cohort for immunogenicity) 112 LU/mL GMC (LU/mL) 95% CI 95% CI Antibody Timing N n % LL UL value LL UL Anti-PD PV1 PRE PI(D30) PII(D90)

16 PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) Seropositivity rate = anti-pd antibody concentration 112 LU/mL GMC = geometric mean antibody concentration N = number of subjects with available results n(%) = number (percentage) of subjects with concentration within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PRE = Blood sample before dose 1 PI(D30) = Blood sample 30 days after dose 1 PII(D90) = Blood sample 30 days after dose 2 Secondary Outcome Variables: Seropositivity rates and GMCs for Anti-PD antibodies measured by ELISA assay (ATP cohort for immunogenicity) 100 EL.U/mL GMC (EL.U/mL) 95% CI 95% CI Antibody Timing N n % LL UL value LL UL Anti-PD PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90)

17 Seropositivity rate = anti-pd antibody concentration 100 EL.U/mL GMC = geometric mean antibody concentration N = number of subjects with available results n(%) = number(percentage) of subjects with concentration within the specified range 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit PRE = Blood sample before dose 1 PI(D30) = Blood sample 30 days after dose 1 PII(D90) = Blood sample 30 days after dose 2 Secondary Outcome Variables: Seropositivity rates and GMTs for OPSONO-1, OPSONO-4, OPSONO-5, OPSONO- 6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19F and OPSONO-23F antibodies (ATP cohort for immunogenicity) 8 GMT 95% CI 95% CI Antibody Timing N n % LL UL value LL UL OPSONO-1 PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) OPSONO-4 PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90)

18 OPSONO-5 PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) OPSONO-6B PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) OPSONO-7F PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30)

19 PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) OPSONO-9V PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) OPSONO-14 PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) OPSONO-18C PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE

20 PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) OPSONO-19F PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90) OPSONO-23F PV1 PRE PI(D30) PII(D90) PV2 PRE PI(D30) PII(D90) PV3 PRE PI(D30) PII(D90) PV4 PRE PI(D30) PII(D90) PV5 PRE PI(D30) PII(D90) PV6 PRE PI(D30) PII(D90) PPV PRE PI(D30) PII(D90)

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.