Multiple Sclerosis, Relapsing-Remitting
Conditions
Brief summary
This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \[TT\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \[23-PPV\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \[13-PCV\], influenza vaccine, keyhole limpet hemocyanin \[KLH\]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).
Interventions
BIOLOGICAL23-PPV
The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B).
BIOLOGICAL13-PCV Booster
The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A).
BIOLOGICALInfluenza Vaccine
The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B).
BIOLOGICALKLH
KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B).
DRUGOCR
OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms.
BIOLOGICALTT Vaccine
The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B).
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of RMS in accordance with the revised McDonald criteria * Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap) * Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive * For sexually active female participants of reproductive potential, use of reliable means of contraception
Exclusion criteria
* Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label * Known presence of other neurologic disorders * Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine | 8 weeks after TT vaccine | For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers | 4 weeks after TT vaccine | For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels. |
| Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | 8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV | Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \> 1 mcg/mL rise compared with pre-vaccination levels. |
| Mean Levels of Anti-Tetanus Antibody | Immediately prior to and at 4 and 8 weeks after TT vaccine | Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA). |
| Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration | Anti-KLH antibody levels were assessed by ELISA. |
| Mean Levels of Anti-KLH Antibody: Ig M | Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration | Anti-KLH antibody levels were assessed by ELISA. |
| Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | 4 weeks after 23-PPV | Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (\>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels. |
| Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes | 4 weeks after 23-PPV | Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \> 1 mcg/mL rise compared with pre-vaccination levels. |
| Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes | 4 weeks after 23-PPV | Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \> 1 mcg/mL rise compared with pre-vaccination levels. |
| Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to and 4 weeks after 23-PPV | Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID). |
| Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV | Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID). |
| Percentage of Participants With Seroprotection | 4 weeks after seasonal influenza vaccine administration | Seroprotection was defined as specific hemagglutination inhibition (HI) titers \>40 at 4 weeks after vaccination. |
| Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | 4 weeks after seasonal influenza vaccine administration | 2-fold increase from prevaccination HI titer. |
| Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | 4 weeks after seasonal influenza vaccine administration | 4-fold increase from prevaccination HI titer. |
| Percentage of Participants With Seroconversion | 4 weeks after influenza immunization | Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer \<10 and an HI titer \>40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer \<10 and HI titer \>/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer \>/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination. |
| Strain-Specific Geometric Mean Titer Levels | Baseline and Week 4 | Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination. |
| Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine | 4 weeks after TT vaccine | For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels. |
| Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| MRI Parameters: Number of T2 Lesions | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| MRI Parameters: Categorical Number of T2 Lesions | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| MRI Parameters: Normalized Brain Volume | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| MRI Parameters: Volume of T2 Lesions: White Matter Volume | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| MRI Parameters: Cortical Grey Matter Volume | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| MRI Parameters: T1 Unenhancing Lesion Volume | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| MRI Parameters: Total Number of Lesions | Baseline | MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters. |
| Cellular Immune Response Assessed by Flow Cytometry | Days 1, 15, 85, 112, 140 and 169 | Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul. Repleted is defined as CD19 \>= LLN or baseline, whichever is lower. |
| Total Immunoglobulin | Days 1, 85, and 169 | — |
| Percentage of Participants With Anti-Drug Antibody Formation | Up to 24 Weeks (ISP) | Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors. |
| Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation | During ISP (24 weeks for Group A and 12 weeks for Group B) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment. |
| Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Immediately prior to and 4 weeks after influenza vaccine | Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination. |
Countries
Canada, United States
Participant flow
Recruitment details
The study recruited participants with relapsing forms of multiple sclerosis in 2 countries from 27 October 2015 to 14 February 2017.
Pre-assignment details
A total of 122 participants were screened of which 102 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Group A1 Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV boosted with 13-PCV and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24. | 33 |
| Group A2 Participants received dual infusion of OCR 300 mg on Day 1 and then on Day 15, and then participants further received immunization course: TT containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH at 12 weeks post-OCR treatment until Week 24. | 35 |
| Group B Participants received immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. | 34 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 5 | 1 |
| Overall Study | Non-compliance | 1 | 1 | 1 |
| Overall Study | Physician Decision | 1 | 1 | 1 |
| Overall Study | Treatment change | 21 | 19 | 22 |
| Overall Study | Withdrawal by Subject | 6 | 7 | 9 |
Baseline characteristics
| Characteristic | Group A1 | Group A2 | Group B | Total |
|---|---|---|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 8 | 39.3 years STANDARD_DEVIATION 9.7 | 41.4 years STANDARD_DEVIATION 7.9 | 40.3 years STANDARD_DEVIATION 8.6 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 29 Participants | 30 Participants | 32 Participants | 91 Participants |
| Race/Ethnicity, Customized Ethnicity Not reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 32 Participants | 32 Participants | 30 Participants | 94 Participants |
| Sex: Female, Male Female | 21 Participants | 24 Participants | 27 Participants | 72 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 7 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 31 / 33 | 34 / 35 | 32 / 34 |
| serious Total, serious adverse events | 5 / 33 | 5 / 35 | 6 / 34 |
Outcome results
Primary
Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.
Time frame: 8 weeks after TT vaccine
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine | 23.9 percentage of participants |
| Group B | Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine | 54.5 percentage of participants |
Comparison: Difference in positive response, Group A minus Group B95% CI: [-50.5, -10.8]
Secondary
Cellular Immune Response Assessed by Flow Cytometry
Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul. Repleted is defined as CD19 \>= LLN or baseline, whichever is lower.
Time frame: Days 1, 15, 85, 112, 140 and 169
Population: Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 not repleted - Day 169 | 96.9 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | >=LLN - Day 140 | 1.5 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | <LLN - Day 140 | 98.5 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 repleted - Day 140 | 1.5 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 not repleted - Day 140 | 98.5 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | >=LLN - Day 169 | 3.1 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | <LLN - Day 169 | 96.9 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 repleted - Day 169 | 3.1 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | >=lower limit of normal range (LLN) - Day 1 | 97.0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | <LLN - Day 1 | 3.0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 repleted - Day 1 | 100.0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 not repleted - Day 1 | 0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | >=LLN - Day 15 | 0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | <LLN - Day 15 | 100.0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 repleted - Day 15 | 0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 not repleted - Day 15 | 100.0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | >=LLN - Day 85 | 0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | <LLN - Day 85 | 100.0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 repleted - Day 85 | 0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 not repleted - Day 85 | 100.0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | >=LLN - Day 112 | 0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | <LLN - Day 112 | 100.0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 repleted - Day 112 | 0 percentage of participants |
| Group A (A1 + A2) | Cellular Immune Response Assessed by Flow Cytometry | CD19 not repleted - Day 112 | 100.0 percentage of participants |
| Group B | Cellular Immune Response Assessed by Flow Cytometry | >=lower limit of normal range (LLN) - Day 1 | 97.0 percentage of participants |
| Group B | Cellular Immune Response Assessed by Flow Cytometry | >=LLN - Day 85 | 90.6 percentage of participants |
| Group B | Cellular Immune Response Assessed by Flow Cytometry | <LLN - Day 1 | 3.0 percentage of participants |
| Group B | Cellular Immune Response Assessed by Flow Cytometry | CD19 repleted - Day 85 | 90.6 percentage of participants |
| Group B | Cellular Immune Response Assessed by Flow Cytometry | CD19 repleted - Day 1 | 100.0 percentage of participants |
| Group B | Cellular Immune Response Assessed by Flow Cytometry | <LLN - Day 85 | 9.4 percentage of participants |
| Group B | Cellular Immune Response Assessed by Flow Cytometry | CD19 not repleted - Day 1 | 0 percentage of participants |
| Group B | Cellular Immune Response Assessed by Flow Cytometry | CD19 not repleted - Day 85 | 9.4 percentage of participants |
Secondary
Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (A1 + A2) | Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions | 10.76 cubic centimeters (cm^3) | Standard Deviation 13.31 |
| Group B | Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions | 7.53 cubic centimeters (cm^3) | Standard Deviation 8.2 |
Secondary
Mean Level of Anti-Pneumococcal Antibody
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Time frame: Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 7F | 1.04 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 17F | 1.48 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 1 | 1.32 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 2 | 1.78 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 1 | 0.84 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 33F | 1.14 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 3 | 1.58 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9N | 0.59 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 23F | 1.11 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 4 | 1.15 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 22F | 1.22 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 22F | 1.06 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 5 | 1.09 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 15B | 1.25 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 20 | 1.63 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 6B | 1.28 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9V | 0.51 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19F | 1.56 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 7F | 1.73 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 2 | 0.98 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19A | 2.04 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 8 | 1.59 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 14 | 2.06 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 18C | 2.05 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9N | 1.08 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 10A | 0.73 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 17F | 1.51 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9V | 0.68 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 33F | 1.36 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 15B | 1.24 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 10A | 0.84 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 12F | 0.91 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 14 | 2.02 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 11F | 1.43 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 11F | 1.09 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 12F | 0.71 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 20 | 1.73 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 11F | 1.29 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 12F | 0.67 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 3 | 0.93 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 10A | 1.05 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 14 | 0.98 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 23F | 1.21 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 9V | 0.88 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 15B | 0.68 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 1 | 1.16 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 9N | 1.09 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 17F | 0.84 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 19F | 1.74 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 8 | 1.83 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 18C | 1.11 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 5 | 0.77 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 7F | 1.73 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19A | 1.24 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 4 | 0.37 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 6B | 1.72 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19F | 1.06 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 19A | 2.35 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 5 | 1.18 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 20 | 1.38 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 6B | 0.64 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 4 | 1.36 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 22F | 0.58 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 8 | 0.89 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 3 | 1.68 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 23F | 0.68 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 18C | 2.29 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 2 | 1.86 mcg/mL |
| Group A (A1 + A2) | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 33F | 0.87 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 15B | 1.66 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 8 | 0.96 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 7F | 0.76 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 1 | 1.05 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 2 | 1.27 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 3 | 1.35 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 4 | 0.88 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 5 | 1.22 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 6B | 1.08 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9N | 0.98 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9V | 1.09 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 10A | 1.01 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 11F | 1.08 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 12F | 0.89 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 14 | 1.67 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 15B | 0.96 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 17F | 0.94 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 18C | 1.04 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19A | 1.99 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19F | 1.13 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 20 | 2.13 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 22F | 0.98 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 23F | 0.77 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 33F | 1.05 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 1 | 1.46 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 2 | 1.79 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 3 | 1.56 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 4 | 1.90 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 5 | 1.44 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 6B | 1.69 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 7F | 1.10 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 8 | 1.97 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9N | 1.35 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9V | 1.21 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 10A | 1.49 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 11F | 1.27 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 12F | 1.66 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 14 | 4.83 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 15B | 1.91 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 17F | 1.35 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 18C | 1.19 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19A | 2.95 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19F | 1.58 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 20 | 2.50 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 22F | 1.14 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 23F | 1.18 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 33F | 1.82 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 1 | 1.34 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 2 | 1.67 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 3 | 1.33 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 4 | 1.84 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 5 | 1.21 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 6B | 1.94 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 7F | 1.07 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 8 | 1.80 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 9N | 1.10 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 9V | 1.08 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 10A | 1.38 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 11F | 1.08 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 12F | 2.33 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 14 | 4.87 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 17F | 1.29 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 18C | 1.18 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 19A | 3.21 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 19F | 1.56 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 20 | 2.59 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 22F | 1.09 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 23F | 1.07 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 33F | 1.68 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 1 | 11.58 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 17F | 5.57 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 1 | 11.38 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 23F | 0.96 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 6B | 0.92 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 2 | 10.07 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 22F | 0.82 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 22F | 4.69 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 3 | 2.99 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 20 | 1.29 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 18C | 7.14 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 4 | 1.96 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19F | 1.16 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 5 | 1.31 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 5 | 9.17 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19A | 2.09 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 33F | 0.67 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 6B | 4.85 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 18C | 1.14 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 19A | 9.56 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 7F | 4.95 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 17F | 1.05 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 4 | 0.59 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 8 | 8.57 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 15B | 1.18 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 33F | 5.01 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 9N | 3.37 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 14 | 1.09 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 19F | 4.91 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 9V | 4.44 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 12F | 0.54 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 2 | 1.25 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 10A | 5.75 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 11F | 1.03 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 23F | 2.44 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 11F | 4.42 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 11F | 4.74 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 10A | 0.96 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 12F | 1.82 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 10A | 5.20 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 20 | 3.56 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 14 | 12.51 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9V | 3.84 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 12F | 2.13 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 15B | 5.60 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9N | 3.26 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9V | 0.74 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 17F | 5.33 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 8 | 9.04 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 1 | 1.02 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 18C | 7.35 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 7F | 4.92 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 14 | 12.29 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19A | 8.96 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 6B | 3.94 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9N | 1.06 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19F | 5.09 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 5 | 10.16 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 8 | 0.91 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 20 | 3.74 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 4 | 2.02 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 8 weeks after 23-PPV: Serotype : 15B | 5.76 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 22F | 4.51 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 3 | 2.76 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 7F | 0.94 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 23F | 2.90 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 2 | 9.41 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 3 | 0.95 mcg/mL |
| Group B | Mean Level of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 33F | 5.11 mcg/mL |
Secondary
Mean Levels of Anti-KLH Antibody: Ig M
Anti-KLH antibody levels were assessed by ELISA.
Time frame: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A (A1 + A2) | Mean Levels of Anti-KLH Antibody: Ig M | Immediately prior to first KLH administration | 100 titer units |
| Group A (A1 + A2) | Mean Levels of Anti-KLH Antibody: Ig M | 4 weeks after first KLH administration | 124 titer units |
| Group A (A1 + A2) | Mean Levels of Anti-KLH Antibody: Ig M | 8 weeks after first KLH administration | 361 titer units |
| Group A (A1 + A2) | Mean Levels of Anti-KLH Antibody: Ig M | 12 weeks after first KLH administration | 372 titer units |
| Group B | Mean Levels of Anti-KLH Antibody: Ig M | 12 weeks after first KLH administration | 1883 titer units |
| Group B | Mean Levels of Anti-KLH Antibody: Ig M | Immediately prior to first KLH administration | 130 titer units |
| Group B | Mean Levels of Anti-KLH Antibody: Ig M | 8 weeks after first KLH administration | 1086 titer units |
| Group B | Mean Levels of Anti-KLH Antibody: Ig M | 4 weeks after first KLH administration | 217 titer units |
Secondary
Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G
Anti-KLH antibody levels were assessed by ELISA.
Time frame: Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A (A1 + A2) | Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | Immediately prior to first KLH administration | 274 titer units |
| Group A (A1 + A2) | Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | 4 weeks after first KLH administration | 384 titer units |
| Group A (A1 + A2) | Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | 8 weeks after first KLH administration | 2916 titer units |
| Group A (A1 + A2) | Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | 12 weeks after first KLH administration | 5298 titer units |
| Group B | Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | 12 weeks after first KLH administration | 60270 titer units |
| Group B | Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | Immediately prior to first KLH administration | 235 titer units |
| Group B | Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | 8 weeks after first KLH administration | 17737 titer units |
| Group B | Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G | 4 weeks after first KLH administration | 1086 titer units |
Secondary
Mean Levels of Anti-Pneumococcal Antibody
Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).
Time frame: Immediately prior to and 4 weeks after 23-PPV
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 10A | 0.88 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 33F | 0.96 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 1 | 0.94 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 1 | 1.31 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 11F | 1.09 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 2 | 1.79 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 6B | 0.84 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 3 | 1.57 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 12F | 0.79 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 4 | 1.54 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 3 | 1.10 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 5 | 1.25 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 14 | 1.33 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 6B | 1.47 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 7F | 0.89 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 7F | 1.36 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 15B | 0.82 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 8 | 1.78 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19F | 1.57 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9N | 1.21 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 17F | 0.89 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9V | 0.94 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 8 | 0.92 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 10A | 1.14 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 18C | 1.08 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 11F | 1.34 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 4 | 0.68 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 12F | 1.13 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19A | 1.58 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 14 | 3.22 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9N | 0.74 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 15B | 1.57 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19F | 1.09 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 17F | 1.41 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 2 | 1.12 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 18C | 1.55 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 20 | 1.71 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19A | 2.47 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 20 | 2.03 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9V | 0.79 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 22F | 1.10 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 22F | 0.73 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 23F | 1.14 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 5 | 0.96 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 33F | 1.44 mcg/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 23F | 0.72 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 33F | 5.11 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19F | 5.09 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 1 | 1.02 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 2 | 1.25 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 3 | 0.95 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 4 | 0.59 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 5 | 1.31 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 6B | 0.92 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 7F | 0.94 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 8 | 0.91 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9N | 1.06 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 9V | 0.74 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 10A | 0.96 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 11F | 1.03 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 12F | 0.54 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 14 | 1.09 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 15B | 1.18 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 17F | 1.05 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 18C | 1.14 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19A | 2.09 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 19F | 1.16 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 20 | 1.29 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 22F | 0.82 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 23F | 0.96 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | Immediately prior to 23-PPV: Serotype : 33F | 0.67 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 1 | 11.58 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 2 | 9.41 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 3 | 2.76 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 4 | 2.02 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 5 | 10.16 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 6B | 3.94 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 7F | 4.92 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 8 | 9.04 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9N | 3.26 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 9V | 3.84 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 10A | 5.20 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 11F | 4.74 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 12F | 1.82 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 14 | 12.51 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 15B | 5.60 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 17F | 5.33 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 18C | 7.35 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 20 | 3.74 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 22F | 4.51 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 23F | 2.90 mcg/mL |
| Group B | Mean Levels of Anti-Pneumococcal Antibody | 4 weeks after 23-PPV: Serotype : 19A | 8.96 mcg/mL |
Secondary
Mean Levels of Anti-Tetanus Antibody
Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA).
Time frame: Immediately prior to and at 4 and 8 weeks after TT vaccine
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A (A1 + A2) | Mean Levels of Anti-Tetanus Antibody | Pre-Vaccination | 1.680 IU/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Tetanus Antibody | 4 weeks after TT vaccine | 4.132 IU/mL |
| Group A (A1 + A2) | Mean Levels of Anti-Tetanus Antibody | 8 weeks after TT vaccine | 3.743 IU/mL |
| Group B | Mean Levels of Anti-Tetanus Antibody | Pre-Vaccination | 2.147 IU/mL |
| Group B | Mean Levels of Anti-Tetanus Antibody | 4 weeks after TT vaccine | 12.157 IU/mL |
| Group B | Mean Levels of Anti-Tetanus Antibody | 8 weeks after TT vaccine | 9.812 IU/mL |
Secondary
MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: 1 lesions | 8 participants |
| Group A (A1 + A2) | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: 3 lesions | 2 participants |
| Group A (A1 + A2) | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: 2 lesions | 2 participants |
| Group A (A1 + A2) | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: >=4 lesions | 9 participants |
| Group A (A1 + A2) | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: 0 lesions | 44 participants |
| Group B | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: >=4 lesions | 2 participants |
| Group B | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: 0 lesions | 31 participants |
| Group B | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: 1 lesions | 0 participants |
| Group B | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: 2 lesions | 1 participants |
| Group B | MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions | Baseline: 3 lesions | 0 participants |
Secondary
MRI Parameters: Categorical Number of T2 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | MRI Parameters: Categorical Number of T2 Lesions | Baseline: 0-5 lesions | 1 participants |
| Group A (A1 + A2) | MRI Parameters: Categorical Number of T2 Lesions | Baseline: 6-9 lesions | 1 participants |
| Group A (A1 + A2) | MRI Parameters: Categorical Number of T2 Lesions | Baseline: >9 lesions | 64 participants |
| Group B | MRI Parameters: Categorical Number of T2 Lesions | Baseline: 0-5 lesions | 0 participants |
| Group B | MRI Parameters: Categorical Number of T2 Lesions | Baseline: 6-9 lesions | 1 participants |
| Group B | MRI Parameters: Categorical Number of T2 Lesions | Baseline: >9 lesions | 33 participants |
Secondary
MRI Parameters: Cortical Grey Matter Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (A1 + A2) | MRI Parameters: Cortical Grey Matter Volume | 521.19 cm^3 | Standard Deviation 35.28 |
| Group B | MRI Parameters: Cortical Grey Matter Volume | 519.70 cm^3 | Standard Deviation 36.18 |
Secondary
MRI Parameters: Normalized Brain Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (A1 + A2) | MRI Parameters: Normalized Brain Volume | 1470.51 cm^3 | Standard Deviation 77.83 |
| Group B | MRI Parameters: Normalized Brain Volume | 1456.35 cm^3 | Standard Deviation 70.03 |
Secondary
MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (A1 + A2) | MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions | 2.85 lesions | Standard Deviation 10.93 |
| Group B | MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions | 0.62 lesions | Standard Deviation 2.65 |
Secondary
MRI Parameters: Number of T2 Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (A1 + A2) | MRI Parameters: Number of T2 Lesions | 57.94 lesions | Standard Deviation 45.43 |
| Group B | MRI Parameters: Number of T2 Lesions | 45.53 lesions | Standard Deviation 28.61 |
Secondary
MRI Parameters: T1 Unenhancing Lesion Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (A1 + A2) | MRI Parameters: T1 Unenhancing Lesion Volume | 1.85 cm^3 | Standard Deviation 2.75 |
| Group B | MRI Parameters: T1 Unenhancing Lesion Volume | 1.31 cm^3 | Standard Deviation 1.75 |
Secondary
MRI Parameters: Total Number of Lesions
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (A1 + A2) | MRI Parameters: Total Number of Lesions | 25.51 lesions | Standard Deviation 27.76 |
| Group B | MRI Parameters: Total Number of Lesions | 18.85 lesions | Standard Deviation 15.99 |
Secondary
MRI Parameters: Volume of T2 Lesions: White Matter Volume
MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.
Time frame: Baseline
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A (A1 + A2) | MRI Parameters: Volume of T2 Lesions: White Matter Volume | 808.22 cm^3 | Standard Deviation 60.11 |
| Group B | MRI Parameters: Volume of T2 Lesions: White Matter Volume | 794.53 cm^3 | Standard Deviation 47.58 |
Secondary
Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers
2-fold increase from prevaccination HI titer.
Time frame: 4 weeks after seasonal influenza vaccine administration
Population: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = BPHU13 | 42.4 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = BBRIS08 | 27.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = H3N2SW13 | 36.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = AHK4801 | 80.0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = H1N1CA09 | 45.7 percentage of participants |
| Group B | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = AHK4801 | 83.3 percentage of participants |
| Group B | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = H1N1CA09 | 87.5 percentage of participants |
| Group B | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = BPHU13 | 80.0 percentage of participants |
| Group B | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = H3N2SW13 | 96.2 percentage of participants |
| Group B | Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers | Strain = BBRIS08 | 73.3 percentage of participants |
Comparison: Strain = H1N1CA09 (Group A2 minus Group B)95% CI: [-61.9, -21.7]
Comparison: Strain = BPHU13 (Group A2 minus Group B)95% CI: [-59.7, -15.5]
Comparison: Strain = H3N2SW13 (Group A2 minus Group B)95% CI: [-78.2, -40.7]
Comparison: Strain = BBRIS08 (Group A2 minus Group B)95% CI: [-76, -15.1]
Comparison: Strain = AHK4801 (Group A2 minus Group B)95% CI: [-49.4, 42.7]
Secondary
Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers
4-fold increase from prevaccination HI titer.
Time frame: 4 weeks after seasonal influenza vaccine administration
Population: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = BPHU13 | 15.2 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = BBRIS08 | 16.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = H1N1CA09 | 20.0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = AHK4801 | 60.0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = H3N2SW13 | 10.0 percentage of participants |
| Group B | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = AHK4801 | 66.7 percentage of participants |
| Group B | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = BPHU13 | 70.0 percentage of participants |
| Group B | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = H3N2SW13 | 92.3 percentage of participants |
| Group B | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = BBRIS08 | 53.3 percentage of participants |
| Group B | Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers | Strain = H1N1CA09 | 81.3 percentage of participants |
Comparison: Strain = H1N1CA09 - Difference in at least 4-fold response, Group A2 minus Group B95% CI: [-80.2, -42.3]
Comparison: Strain = BPHU13 - Difference in at least 4-fold response, Group A2 minus Group B95% CI: [-75.3, -34.4]
Comparison: Strain = H3N2SW13 - Difference in at least 4-fold response, Group A2 minus Group B95% CI: [-97.1, -67.5]
Comparison: Strain = BBRIS08 - Difference in at least 4-fold response, Group A2 minus Group B95% CI: [-67.2, -6.1]
Comparison: Strain = AHK4801 - Difference in at least 4-fold response, Group A2 minus Group B95% CI: [-63.8, 50.5]
Secondary
Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment.
Time frame: During ISP (24 weeks for Group A and 12 weeks for Group B)
Population: Safety population included all participants who received any ocrelizumab or any vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation | AEs | 82.4 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation | Serious AEs | 0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 percentage of participants |
| Group B | Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation | AEs | 50.0 percentage of participants |
| Group B | Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation | Serious AEs | 0 percentage of participants |
| Group B | Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation | AEs Leading to Study Discontinuation | 0 percentage of participants |
Secondary
Percentage of Participants With Anti-Drug Antibody Formation
Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.
Time frame: Up to 24 Weeks (ISP)
Population: Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for participants with measurable ADA samples.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Anti-Drug Antibody Formation | Baseline | 0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Anti-Drug Antibody Formation | Post-baseline | 0 percentage of participants |
| Group B | Percentage of Participants With Anti-Drug Antibody Formation | Post-baseline | 0 percentage of participants |
Secondary
Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \> 1 mcg/mL rise compared with pre-vaccination levels.
Time frame: 4 weeks after 23-PPV
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes | 37.3 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes | 97.1 percentage of participants |
95% CI: [-72.6, -46.8]
Secondary
Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \> 1 mcg/mL rise compared with pre-vaccination levels.
Time frame: 4 weeks after 23-PPV
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes | 86.6 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes | 100.0 percentage of participants |
95% CI: [-21.6, -5.3]
Secondary
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or \> 1 mcg/mL rise compared with pre-vaccination levels.
Time frame: 8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 12F | 22.6 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 5 | 38.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 33F | 45.2 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 11A | 32.3 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 6B | 48.4 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 19F | 41.9 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 10A | 29.0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 7F | 51.6 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 17F | 41.9 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 9V | 51.6 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 8 | 54.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 1 | 54.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 9N | 45.2 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 19A | 58.1 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 15B | 35.5 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 2 | 54.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 23F | 48.4 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 20 | 25.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 3 | 35.5 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 22F | 38.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 14 | 64.5 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 4 | 32.3 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 18C | 51.6 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 14 | 67.6 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 20 | 14.7 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 22F | 23.5 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 23F | 29.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 33F | 44.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 1 | 38.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 2 | 44.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 3 | 29.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 4 | 23.5 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 5 | 44.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 6B | 44.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 7F | 35.3 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 8 | 67.6 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 9N | 47.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 9V | 50.0 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 10A | 29.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 11A | 44.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 12F | 20.6 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 15B | 38.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 17F | 44.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 18C | 32.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 19A | 35.3 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 19F | 29.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 18C | 94.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 11A | 82.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 4 | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 22F | 91.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 12F | 79.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 3 | 85.3 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 2 | 97.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 14 | 85.3 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 1 | 100.0 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 19F | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 15B | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 33F | 94.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 19A | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 8 | 97.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 17F | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 9N | 82.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 7F | 94.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 23F | 76.5 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 9V | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 6B | 82.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 20 | 85.3 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 10A | 91.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV | Serotype 5 | 97.1 percentage of participants |
Comparison: Serotype 1- Difference in positive response, Group A1 minus Group B95% CI: [-62.7, -27.6]
Comparison: Serotype 2- Difference in positive response, Group A1 minus Group B95% CI: [-60.6, -23.8]
Comparison: Serotype 3- Difference in positive response, Group A1 minus Group B95% CI: [-70.4, -29.2]
Comparison: Serotype 4- Difference in positive response, Group A1 minus Group B95% CI: [-75.7, -36.3]
Comparison: Serotype 5- Difference in positive response, Group A1 minus Group B95% CI: [-76.4, -40.3]
Comparison: Serotype 6B- Difference in positive response, Group A1 minus Group B95% CI: [-55.7, -12.2]
Comparison: Serotype 7F- Difference in positive response, Group A1 minus Group B95% CI: [-61.8, -23.2]
Comparison: Serotype 8- Difference in positive response, Group A1 minus Group B95% CI: [-60.6, -23.8]
Comparison: Serotype 9N- Difference in positive response, Group A1 minus Group B95% CI: [-58.9, -15.5]
Comparison: Serotype 9V- Difference in positive response, Group A1 minus Group B95% CI: [-57.3, -16]
Comparison: Serotype 10A- Difference in positive response, Group A1 minus Group B95% CI: [-80.8, -43.5]
Comparison: Serotype 11A- Difference in positive response, Group A1 minus Group B95% CI: [-71, -29.2]
Comparison: Serotype 12F- Difference in positive response, Group A1 minus Group B95% CI: [-76.9, -36.8]
Comparison: Serotype 14- Difference in positive response, Group A1 minus Group B95% CI: [-41.4, -0.2]
Comparison: Serotype 15B- Difference in positive response, Group A1 minus Group B95% CI: [-72.8, -32.7]
Comparison: Serotype 17F- Difference in positive response, Group A1 minus Group B95% CI: [-66.8, -25.8]
Comparison: Serotype 18C- Difference in positive response, Group A1 minus Group B95% CI: [-61.8, -23.2]
Comparison: Serotype 19A- Difference in positive response, Group A1 minus Group B95% CI: [-50.6, -9.7]
Comparison: Serotype 19F- Difference in positive response, Group A1 minus Group B95% CI: [-66.8, -25.8]
Comparison: Serotype 20- Difference in positive response, Group A1 minus Group B95% CI: [-79, -40]
Comparison: Serotype 22F- Difference in positive response, Group A1 minus Group B95% CI: [-72.1, -32.8]
Comparison: Serotype 23F- Difference in positive response, Group A1 minus Group B95% CI: [-50.7, -5.4]
Comparison: Serotype 33F- Difference in positive response, Group A1 minus Group B95% CI: [-68.2, -29.7]
Comparison: Serotype 1- Difference in positive response, Group A2 minus Group B95% CI: [-78.1, -45.4]
Comparison: Serotype 2- Difference in positive response, Group A2 minus Group B95% CI: [-70.6, -35.3]
Comparison: Serotype 3- Difference in positive response, Group A2 minus Group B95% CI: [-75.3, -36.5]
Comparison: Serotype 4- Difference in positive response, Group A2 minus Group B95% CI: [-82.6, -46.8]
Comparison: Serotype 5- Difference in positive response, Group A2 minus Group B95% CI: [-70.6, -35.3]
Comparison: Serotype 6B- Difference in positive response, Group A2 minus Group B95% CI: [-59.3, -17.2]
Comparison: Serotype 7F- Difference in positive response, Group A2 minus Group B95% CI: [-76.7, -40.9]
Comparison: Serotype 8- Difference in positive response, Group A2 minus Group B95% CI: [-46.1, -12.7]
Comparison: Serotype 9N- Difference in positive response, Group A2 minus Group B95% CI: [-56.4, -14.2]
Comparison: Serotype 9V- Difference in positive response, Group A2 minus Group B95% CI: [-58.2, -18.2]
Comparison: Serotype 10A- Difference in positive response, Group A2 minus Group B95% CI: [-79.8, -43.7]
Comparison: Serotype 11A- Difference in positive response, Group A2 minus Group B95% CI: [-59.3, -17.2]
Comparison: Serotype 12F- Difference in positive response, Group A2 minus Group B95% CI: [-78, -39.6]
Comparison: Serotype 14- Difference in positive response, Group A2 minus Group B95% CI: [-37.4, 2.1]
Comparison: Serotype 15B- Difference in positive response, Group A2 minus Group B95% CI: [-69.6, -30.4]
Comparison: Serotype 17F- Difference in positive response, Group A2 minus Group B95% CI: [-64, -24.2]
Comparison: Serotype 18C- Difference in positive response, Group A2 minus Group B95% CI: [-79.4, -44.2]
Comparison: Serotype 19A- Difference in positive response, Group A2 minus Group B95% CI: [-72.3, -33.6]
Comparison: Serotype 19F- Difference in positive response, Group A2 minus Group B95% CI: [-77.6, -40.1]
Comparison: Serotype 20- Difference in positive response, Group A2 minus Group B95% CI: [-87.4, -53.8]
Comparison: Serotype 22F- Difference in positive response, Group A2 minus Group B95% CI: [-84.8, -50.5]
Comparison: Serotype 23F- Difference in positive response, Group A2 minus Group B95% CI: [-68, -26.1]
Comparison: Serotype 33F- Difference in positive response, Group A2 minus Group B95% CI: [-68.5, -31.5]
Secondary
Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV
Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (\>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels.
Time frame: 4 weeks after 23-PPV
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 11A | 29.9 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 6B | 47.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 7F | 32.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 8 | 64.2 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 9N | 41.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 9V | 50.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 10A | 28.4 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 12F | 20.9 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 14 | 62.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 15B | 40.3 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 17F | 31.3 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 18C | 38.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 19A | 41.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 19F | 32.8 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 20 | 20.9 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 22F | 34.3 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 23F | 43.3 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 33F | 46.3 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 1 | 49.3 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 2 | 53.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 3 | 34.3 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 4 | 28.4 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 5 | 40.3 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 18C | 91.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 11A | 82.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 33F | 94.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 6B | 85.3 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 19A | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 7F | 91.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 3 | 82.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 8 | 97.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 19F | 85.3 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 9N | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 1 | 100.0 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 9V | 91.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 20 | 82.4 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 10A | 91.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 5 | 94.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 12F | 76.5 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 22F | 91.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 14 | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 2 | 97.1 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 15B | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 23F | 76.5 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 17F | 88.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV | Serotype 4 | 91.2 percentage of participants |
Comparison: Serotype 195% CI: [-62.7, -38.8]
Comparison: Serotype 295% CI: [-56.5, -30.1]
Comparison: Serotype 395% CI: [-65.2, -30.9]
Comparison: Serotype 495% CI: [-77.2, -48.4]
Comparison: Serotype 595% CI: [-68, -39.7]
Comparison: Serotype 6B95% CI: [-54.4, -20.7]
Comparison: Serotype 7F95% CI: [-73.1, -43.6]
Comparison: Serotype 895% CI: [-45.7, -20.1]
Comparison: Serotype 9N95% CI: [-62.5, -30.4]
Comparison: Serotype 9V95% CI: [-55.7, -25.1]
Comparison: Serotype 10A95% CI: [-77.2, -48.4]
Comparison: Serotype 11A95% CI: [-69.4, -35.6]
Comparison: Serotype 12F95% CI: [-72.8, -38.3]
Comparison: Serotype 1495% CI: [-41.4, -9.7]
Comparison: Serotype 15B95% CI: [-63.9, -32]
Comparison: Serotype 17F95% CI: [-72.4, -41.4]
Comparison: Serotype 18C95% CI: [-67.4, -37.3]
Comparison: Serotype 19A95% CI: [-62.5, -30.4]
Comparison: Serotype 19F95% CI: [-68.8, -36.1]
Comparison: Serotype 2095% CI: [-77.5, -45.4]
Comparison: Serotype 22F95% CI: [-71.7, -42]
Comparison: Serotype 23F95% CI: [-51.7, -14.6]
Comparison: Serotype 33F95% CI: [-62.2, -33.5]
Secondary
Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Time frame: 4 weeks after TT vaccine
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine | 24.2 percentage of participants |
| Group B | Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine | 60.6 percentage of participants |
Comparison: Difference in positive response, Group A minus Group B95% CI: [-56, -16.7]
Secondary
Percentage of Participants With Seroconversion
Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer \<10 and an HI titer \>40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer \<10 and HI titer \>/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer \>/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination.
Time frame: 4 weeks after influenza immunization
Population: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Seroconversion | Strain = H3N2SW13 (as per protocol) | 20.0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroconversion | Strain = BPHU13 (as per protocol) | 0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroconversion | Strain = BBRIS08 (as per FDA guidance) | 16.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroconversion | Strain = BPHU13 (as per FDA guidance) | 12.1 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroconversion | Strain = BBRIS08 (as per protocol) | 0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroconversion | Strain = H3N2SW13 (as per FDA guidance) | 10.0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroconversion | Strain = AHK4801 (as per FDA guidance) | 60.0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroconversion | Strain = H1N1CA09 (as per protocol) | 42.9 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroconversion | Strain = H1N1CA09 (as per FDA guidance) | 20.0 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = AHK4801 (as per FDA guidance) | 66.7 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = AHK4801 (as per protocol) | 100.0 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = H1N1CA09 (as per FDA guidance) | 81.3 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = H1N1CA09 (as per protocol) | 88.9 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = BPHU13 (as per FDA guidance) | 70.0 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = BPHU13 (as per protocol) | 55.6 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = H3N2SW13 (as per FDA guidance) | 88.5 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = H3N2SW13 (as per protocol) | 77.8 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = BBRIS08 (as per FDA guidance) | 53.3 percentage of participants |
| Group B | Percentage of Participants With Seroconversion | Strain = BBRIS08 (as per protocol) | 25.0 percentage of participants |
Comparison: Strain = H1N1CA09 (Group A2 minus Group B) \[FDA\]95% CI: [-80.2, -42.3]
Comparison: Strain = H1N1CA09 (Group A2 minus Group B) \[Protocol\]95% CI: [-88, -4]
Comparison: Strain = BPHU13 (Group A2 minus Group B) \[FDA\]95% CI: [-77.7, -38.1]
Comparison: Strain = BPHU13 (Group A2 minus Group B) \[Protocol\]95% CI: [-88, -23.1]
Comparison: Strain = H3N2SW13 (Group A2 minus Group B) \[FDA\]95% CI: [-94.8, -62.2]
Comparison: Strain = H3N2SW13 (Group A2 minus Group B) \[Protocol\]95% CI: [-100, -13.4]
Comparison: Strain = BBRIS08 (Group A2 minus Group B) \[FDA\]95% CI: [-67.2, -6.1]
Comparison: Strain = BBRIS08 (Group A2 minus Group B) \[Protocol\]95% CI: [-67.4, 17.4]
Comparison: Strain = AHK4801 (Group A2 minus Group B) \[FDA\]95% CI: [-63.8, 50.5]
Secondary
Percentage of Participants With Seroprotection
Seroprotection was defined as specific hemagglutination inhibition (HI) titers \>40 at 4 weeks after vaccination.
Time frame: 4 weeks after seasonal influenza vaccine administration
Population: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Seroprotection | Strain = BPHU13 | 66.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroprotection | Strain = BBRIS08 | 55.6 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroprotection | Strain = H3N2SW13 | 66.7 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroprotection | Strain = AHK4801 | 80.0 percentage of participants |
| Group A (A1 + A2) | Percentage of Participants With Seroprotection | Strain = H1N1CA09 | 71.4 percentage of participants |
| Group B | Percentage of Participants With Seroprotection | Strain = AHK4801 | 83.3 percentage of participants |
| Group B | Percentage of Participants With Seroprotection | Strain = H1N1CA09 | 97.0 percentage of participants |
| Group B | Percentage of Participants With Seroprotection | Strain = BPHU13 | 80.6 percentage of participants |
| Group B | Percentage of Participants With Seroprotection | Strain = H3N2SW13 | 92.6 percentage of participants |
| Group B | Percentage of Participants With Seroprotection | Strain = BBRIS08 | 75.0 percentage of participants |
Comparison: Strain = H1N1CA09 (Group A2 minus Group B)95% CI: [-41.6, -9.5]
Comparison: Strain = BPHU13 (Group A2 minus Group B)95% CI: [-35.2, 7.3]
Comparison: Strain = H3N2SW13 (Group A2 minus Group B)95% CI: [-45.5, -6.4]
Comparison: Strain = BBRIS08 (Group A2 minus Group B)95% CI: [-50.7, 11.8]
Comparison: Strain = AHK4801 (Group A2 minus Group B)95% CI: [-49.4, 42.7]
Secondary
Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.
Time frame: 4 weeks after TT vaccine
Population: OC population included all randomized participants who completed the ISP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A (A1 + A2) | Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers | 40.9 percentage of participants |
| Group B | Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers | 87.9 percentage of participants |
Comparison: Difference in positive response, Group A minus Group B95% CI: [-63.2, -30.7]
Secondary
Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination
Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination.
Time frame: Immediately prior to and 4 weeks after influenza vaccine
Population: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (A1 + A2) | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = BPHU13 | 1.35 ratio | Standard Deviation 1.62 |
| Group A (A1 + A2) | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = BBRIS08 | 1.38 ratio | Standard Deviation 1.9 |
| Group A (A1 + A2) | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = H3N2SW13 | 1.25 ratio | Standard Deviation 0.94 |
| Group A (A1 + A2) | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = AHK4801 | 2.30 ratio | Standard Deviation 1.6 |
| Group A (A1 + A2) | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = H1N1CA09 | 1.31 ratio | Standard Deviation 1.04 |
| Group B | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = AHK4801 | 2.83 ratio | Standard Deviation 3.34 |
| Group B | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = H1N1CA09 | 5.74 ratio | Standard Deviation 21.05 |
| Group B | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = BPHU13 | 6.45 ratio | Standard Deviation 28.31 |
| Group B | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = H3N2SW13 | 8.18 ratio | Standard Deviation 11.7 |
| Group B | Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination | Strain = BBRIS08 | 4.68 ratio | Standard Deviation 9.19 |
Secondary
Strain-Specific Geometric Mean Titer Levels
Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination.
Time frame: Baseline and Week 4
Population: OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = H1N1CA09 | 126.5 hemagglutination inhibition titers |
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = H1N1CA09 | 154.8 hemagglutination inhibition titers |
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = BPHU13 | 67.7 hemagglutination inhibition titers |
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = BPHU13 | 84.6 hemagglutination inhibition titers |
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = H3N2SW13 | 110.0 hemagglutination inhibition titers |
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = H3N2SW13 | 134.5 hemagglutination inhibition titers |
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = BBRIS08 | 49.3 hemagglutination inhibition titers |
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = BBRIS08 | 65.8 hemagglutination inhibition titers |
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = AHK4801 | 52.8 hemagglutination inhibition titers |
| Group A (A1 + A2) | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = AHK4801 | 121.3 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = BBRIS08 | 311.7 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = H1N1CA09 | 86.0 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = H3N2SW13 | 342.8 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = H1N1CA09 | 390.8 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = AHK4801 | 127.0 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = BPHU13 | 54.0 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = BBRIS08 | 71.3 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | 4 weeks after influenza vaccine: Strain = BPHU13 | 243.1 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = AHK4801 | 45.9 hemagglutination inhibition titers |
| Group B | Strain-Specific Geometric Mean Titer Levels | Prior to influenza vaccine: Strain = H3N2SW13 | 62.6 hemagglutination inhibition titers |
Secondary
Total Immunoglobulin
Time frame: Days 1, 85, and 169
Population: Safety population included all participants who received any ocrelizumab or any vaccine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (A1 + A2) | Total Immunoglobulin | Day 1 | 13.45 grams per liter (g/L) | Standard Deviation 2.75 |
| Group A (A1 + A2) | Total Immunoglobulin | Day 85 | 13.45 grams per liter (g/L) | Standard Deviation 2.8 |
| Group A (A1 + A2) | Total Immunoglobulin | Day 169 | 13.26 grams per liter (g/L) | Standard Deviation 2.62 |
| Group B | Total Immunoglobulin | Day 1 | 14.05 grams per liter (g/L) | Standard Deviation 3.01 |
| Group B | Total Immunoglobulin | Day 85 | 14.53 grams per liter (g/L) | Standard Deviation 3.19 |