Influenza
Conditions
Keywords
Immunogenicity, Influsplit Tetra (Fluarix Tetra) 2014/2015 season, Safety, Adults, Pneumovax 23/Pneumovax, Co-administration, Elderly, Seasonal influenza, Pneumococcal infection
Brief summary
The purpose of this study is to investigate the immunogenicity and safety when GSK Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age and older at risk for complications from influenza and pneumococcal infections.
Interventions
BIOLOGICALInflusplit™ Tetra (Fluarix™ Tetra)
Intramuscular injection, 1 dose each in Control and Co-Ad groups.
BIOLOGICALPneumovax™ 23
Intramuscular injection, 1 dose each in Control and Co-Ad groups.
BIOLOGICALPlacebo (Saline)
Intramuscular injection, 1 dose each in Control and Co-Ad groups.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * A male or female aged 50 years or above at the time of the first vaccination at risk for complications from influenza and/or pneumococcal infections, meeting their respective countries' recommendations for vaccination against influenza and pneumococcal disease. * At risk subjects include adults with chronic respiratory, heart, kidney, liver or neurological disease; human immunodeficiency virus (HIV) disease on combination antiretroviral therapy (cART) with cluster of differentiation 4 (CD4) T-cell counts greater than 350 cells/mm3; sickle cell disease or coeliac syndrome that may lead to splenic dysfunction (all other asplenics are excluded). The decision to enrol should be based on the investigators clinical judgement. * Written informed consent obtained from the subject. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled, topical and low-dose intra-articular steroids are allowed. * Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose and 30 days after the last dose of vaccine. * Administration of such a vaccine has to be documented in the Concomitant vaccination of the electronic Case Report Form (eCRF). * Administration of long-acting immune-modifying drugs/treatment within six months prior to the first vaccine dose or expected administration at any time during the study period. These immunosuppressant drugs/treatment/Biologics include: * Methotrexate * Leflunomide * Azathioprine and 6-mercaptopurine * Cyclosporin A * Cyclophosphamide * Tacrolimus, everolimus, sirolimus, temsirolimus * Mycophenolate mofetil * Antilymfocytaire immunoglobulins * Tumor Necrosis Factor (TNF) inhibitors: Adalimumab (Humira®), certolizumab (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®) and infliximab(Remicade®) * Monoclonal antibodies and other biologicals: Rituximab (Mabthera®), Abatacept (Orencia®), tocilizumab (RoActemra®), basiliximab (Simulect®), Natalizumab (Tysabri®) cluster of differentiation 3 (CD3), … * Antitumor agents: alkylating agents, antimetabolites, antitumor antibiotics, topoisomerase inhibitors, microtubule inhibitors and other anti-tumor agents * Lenalidomide Revlimid® * Tasonermin: Beromun® * Proleukin® (aldesleukin; Novartis, …) * Tyrosine kinase inhibitor (Glivec®)Omalizumab Xolair® * Eculizumab Soliris® The above list is compiled from: \[Federal Public Service Belgium: Health, Food Chain Safety and Environment\]. * Any immunosuppressive treatment which in the opinion of the investigator will not allow an adequate immune response. Inhaled, topical and low-dose intra-articular steroids are allowed. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. * Previous vaccination with a pneumococcal vaccine within the last five years. * Previous vaccination with an influenza vaccine within the last six months. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. HIV infected subjects on cART with CD4 T-cell counts above 350 cells/mm3 can be enrolled. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 38.0°C (100.4°F). The preferred route for recording temperature in this study will be axillary. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever \[≥ 38.0°C (100.4°F)\] may be enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular (IM) injection unsafe. * Asplenia or dysfunction of the spleen. This excludes homozygous sickle cell disease or coeliac syndrome that may lead to splenic dysfunction. * Acute clinically significant (i.e. a medically significant change from baseline condition in the past 30 days) pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * History of chronic alcohol consumption and/or drug abuse. * History of Guillain-Barré syndrome. * A history of anaphylaxis following ANY vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | At Day 28 post Influsplit™ Tetra vaccination | HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata). |
| Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | At 28 days after Pneumovax™ 23 vaccination | Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited General Adverse Events (AEs) | Within 7 days (Days 0 - 6) after each dose and across doses. | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms\*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (\>)39.0°C. \*Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain |
| Duration of Local Adverse Events | During the 7-day (Days 0-6) post-vaccination period | Duration was defined as number of days with any grade of local symptoms. |
| Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs) | Throughout the study period (Days 0-180) | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs) | During the entire study period (Days 0-180) | Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Within the 28-day (Days 0-27) post-vaccination period | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Throughout the study period (Days 0-180) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Duration of Solicited General AEs. | During the 7-day (Days 0-6) post-vaccination period | Duration was defined as number of days with any grade of general symptoms. |
| Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | At Day 0 and Day 28 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata). |
| Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | At Day 28 | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata). |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | At Day 28 | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata). |
| Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only) | The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml. PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group. POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group. |
| Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only) | Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group. POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group. |
| Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | At 28 days post-vaccination with Pneumovax™ 23 | Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4. The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | At Day 0 and Day 28 | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata). |
| Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Within 7 days (Days 0 - 6) after each dose and across doses. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. \> 100mm. |
Countries
Belgium, France
Participant flow
Recruitment details
In the Control Group, 2 subjects withdrew at Day 0. In the Co-Ad Group, 4 subjects withdrew at Day 0, 1 subject withdrew at Day 28 and 1 subject withdrew at Day 56.
Pre-assignment details
Of the 357 subjects enrolled, 1 subject failed to meet the inclusion criteria hence he/she was excluded from study start.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28. | 179 |
| Co-Ad Group Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28. | 177 |
| Total | 356 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Unwilling to be vaccinated in left arm | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Control Group | Co-Ad Group | Total |
|---|---|---|---|
| Age, Continuous | 68.4 Years STANDARD_DEVIATION 9.4 | 68.1 Years STANDARD_DEVIATION 9 | 68.3 Years STANDARD_DEVIATION 9.2 |
| Race/Ethnicity, Customized African Heritage / African American | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Mixed Origin | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 175 Participants | 172 Participants | 347 Participants |
| Sex: Female, Male Female | 77 Participants | 76 Participants | 153 Participants |
| Sex: Female, Male Male | 102 Participants | 101 Participants | 203 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 117 / 179 | 127 / 177 |
| serious Total, serious adverse events | 11 / 179 | 7 / 177 |
Outcome results
Primary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).
Time frame: At Day 28 post Influsplit™ Tetra vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | H1N1 | 253.2 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | H3N2 | 73.6 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | Victoria | 178.7 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | Yamagata | 346.5 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | Yamagata | 353.8 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | H1N1 | 235.5 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | Victoria | 157.9 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains. | H3N2 | 78.6 Titers |
Comparison: The adjusted GMT of HI antibodies for H1N1 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.95% CI: [0.88, 1.46]ANCOVA
Comparison: The adjusted GMT of HI antibodies for H3N2 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.95% CI: [0.78, 1.21]ANCOVA
Comparison: The adjusted GMT of HI antibodies for Victoria strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.95% CI: [0.98, 1.4]ANCOVA
Comparison: The adjusted GMT of HI antibodies for Yamagata strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.95% CI: [0.84, 1.16]ANCOVA
Primary
Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).
Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).
Time frame: At 28 days after Pneumovax™ 23 vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 01 IgG | 5.5 ug per ml |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 03 IgG | 1.7 ug per ml |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 04 IgG | 2.3 ug per ml |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 7F IgG | 9.0 ug per ml |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 14 IgG | 20.2 ug per ml |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 19A IgG | 9.2 ug per ml |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 14 IgG | 14.1 ug per ml |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 01 IgG | 4.9 ug per ml |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 7F IgG | 8.1 ug per ml |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 03 IgG | 1.7 ug per ml |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 19A IgG | 7.7 ug per ml |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A). | Polysaccharide 04 IgG | 1.7 ug per ml |
Comparison: Anti-pneumococcal antibody concentrations for Polysaccharide 01 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.95% CI: [0.86, 1.5]ANCOVA
Comparison: Anti-pneumococcal antibody concentrations for Polysaccharide 03 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.95% CI: [0.96, 1.45]ANCOVA
Comparison: Anti-pneumococcal antibody concentrations for Polysaccharide 04 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.95% CI: [0.98, 1.62]ANCOVA
Comparison: Anti-pneumococcal antibody concentrations for Polysaccharide 7F serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.95% CI: [0.95, 1.63]ANCOVA
Comparison: Anti-pneumococcal antibody concentrations for Polysaccharide 14 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.95% CI: [0.91, 1.57]ANCOVA
Comparison: Anti-pneumococcal antibody concentrations for Polysaccharide 19A serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.95% CI: [1.05, 1.7]ANCOVA
Secondary
Duration of Local Adverse Events
Duration was defined as number of days with any grade of local symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Duration of Local Adverse Events | Pain, Dose 1 | 2.0 Days |
| Control Group | Duration of Local Adverse Events | Pain, Dose 2 | 2.0 Days |
| Control Group | Duration of Local Adverse Events | Redness, Dose 1 | 4.0 Days |
| Control Group | Duration of Local Adverse Events | Redness, Dose 2 | 2.0 Days |
| Control Group | Duration of Local Adverse Events | Swelling, Dose 1 | 4.5 Days |
| Control Group | Duration of Local Adverse Events | Swelling, Dose 2 | 3.0 Days |
| Co-Ad Group | Duration of Local Adverse Events | Pain, Dose 1 | 2.0 Days |
| Co-Ad Group | Duration of Local Adverse Events | Swelling, Dose 1 | 2.0 Days |
| Co-Ad Group | Duration of Local Adverse Events | Pain, Dose 2 | 2.0 Days |
| Co-Ad Group | Duration of Local Adverse Events | Redness, Dose 2 | 1.0 Days |
| Co-Ad Group | Duration of Local Adverse Events | Redness, Dose 1 | 2.0 Days |
Secondary
Duration of Solicited General AEs.
Duration was defined as number of days with any grade of general symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control Group | Duration of Solicited General AEs. | Gastrointestinal symptoms, Dose 2 | 3.0 Days |
| Control Group | Duration of Solicited General AEs. | Muscle aches, Dose 1 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Fatigue, Dose 1 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Muscle aches, Dose 2 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Headache, Dose 1 | 1.0 Days |
| Control Group | Duration of Solicited General AEs. | Sweating, Dose 1 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Gastrointestinal symptoms, Dose 1 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Sweating, Dose 2 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Headache, Dose 2 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Shivering, Dose 1 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Joint pain, Dose 1 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Shivering, Dose 2 | 1.0 Days |
| Control Group | Duration of Solicited General AEs. | Fatigue, Dose 2 | 3.0 Days |
| Control Group | Duration of Solicited General AEs. | Joint pain, Dose 2 | 2.0 Days |
| Control Group | Duration of Solicited General AEs. | Fever, Dose 2 | 1.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Joint pain, Dose 2 | 2.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Fatigue, Dose 1 | 2.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Fatigue, Dose 2 | 3.5 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Gastrointestinal symptoms, Dose 1 | 2.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Gastrointestinal symptoms, Dose 2 | 3.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Headache, Dose 1 | 1.5 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Joint pain, Dose 1 | 2.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Headache, Dose 2 | 2.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Muscle aches, Dose 1 | 3.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Muscle aches, Dose 2 | 2.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Sweating, Dose 1 | 2.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Sweating, Dose 2 | 2.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Shivering, Dose 1 | 1.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Shivering, Dose 2 | 3.0 Days |
| Co-Ad Group | Duration of Solicited General AEs. | Fever, Dose 1 | 1.0 Days |
Secondary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains
HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).
Time frame: At Day 0 and Day 28
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | H1N1, Day 0 | 32.4 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | H1N1, Day 28 | 34.0 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | H3N2, Day 0 | 20.8 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | H3N2, Day 28 | 73.6 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | Victoria, Day 0 | 48.7 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | Victoria, Day 28 | 178.7 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | Yamagata, Day 0 | 120.7 Titers |
| Control Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | Yamagata, Day 28 | 346.5 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | Yamagata, Day 28 | 353.8 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | H1N1, Day 0 | 253.2 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | Victoria, Day 0 | 51.5 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | H1N1, Day 28 | 235.5 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | Yamagata, Day 0 | 119.9 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | H3N2, Day 0 | 21.8 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | Victoria, Day 28 | 157.9 Titers |
| Co-Ad Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains | H3N2, Day 28 | 78.6 Titers |
Secondary
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.
MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).
Time frame: At Day 28
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Control Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | Victoria | 3.6 Fold increase |
| Control Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | H1N1 | 7.7 Fold increase |
| Control Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | Yamagata | 2.8 Fold increase |
| Control Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | H3N2 | 3.5 Fold increase |
| Co-Ad Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | Yamagata | 3.0 Fold increase |
| Co-Ad Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | H1N1 | 6.9 Fold increase |
| Co-Ad Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | Victoria | 3.1 Fold increase |
| Co-Ad Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. | H3N2 | 3.6 Fold increase |
Secondary
Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).
Time frame: At Day 28
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1 | 110 Subjects |
| Control Group | Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2 | 62 Subjects |
| Control Group | Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria | 73 Subjects |
| Control Group | Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata | 60 Subjects |
| Co-Ad Group | Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata | 54 Subjects |
| Co-Ad Group | Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1 | 101 Subjects |
| Co-Ad Group | Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria | 55 Subjects |
| Co-Ad Group | Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2 | 61 Subjects |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: Within the 28-day (Days 0-27) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any Unsolicited AEs | 35 Subjects |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 Unsolicited AEs | 5 Subjects |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related Unsolicited AEs | 5 Subjects |
| Co-Ad Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any Unsolicited AEs | 42 Subjects |
| Co-Ad Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 Unsolicited AEs | 8 Subjects |
| Co-Ad Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related Unsolicited AEs | 5 Subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: Throughout the study period (Days 0-180)
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Any SAE(s) | 11 Subjects |
| Control Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
| Control Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Fatal SAE(s) | 0 Subjects |
| Control Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related Fatal SAE(s) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related Fatal SAE(s) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Any SAE(s) | 7 Subjects |
| Co-Ad Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Fatal SAE(s) | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related SAE(s) | 0 Subjects |
Secondary
Number of Subjects Reporting Solicited General Adverse Events (AEs)
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms\*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (\>)39.0°C. \*Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain
Time frame: Within 7 days (Days 0 - 6) after each dose and across doses.
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Sweating, Dose 1 | 11 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fatigue, Dose 1 | 30 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fatigue, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any GI symptoms, Dose 1 | 16 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 GI symptoms, Dose 1 | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related GI symptoms, Dose 1 | 9 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Headache, Dose 1 | 21 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Headache, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Headache, Dose 1 | 13 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Joint pain, Dose 1 | 11 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Joint pain, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Joint pain, Dose 1 | 6 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Muscle aches, Dose 1 | 15 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Muscle aches, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Muscle aches, Dose 1 | 12 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Shivering, Dose 1 | 6 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Shivering, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Shivering, Dose 1 | 5 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fatigue, Dose 1 | 23 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Sweating, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Sweating, Dose 1 | 9 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fever, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fever, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fever, Dose 1 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fatigue, Dose 2 | 25 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fatigue, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fatigue, Dose 2 | 22 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any GI symptoms, Dose 2 | 11 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 GI symptoms, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related GI symptoms, Dose 2 | 9 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Headache, Dose 2 | 18 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Headache, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Headache, Dose 2 | 14 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Joint pain, Dose 2 | 17 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Joint pain, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Joint pain, Dose 2 | 12 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Muscle aches, Dose 2 | 21 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Muscle aches, Dose 2 | 4 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Muscle aches, Dose 2 | 19 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Shivering, Dose 2 | 8 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Shivering, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Shivering, Dose 2 | 5 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Sweating, Dose 2 | 10 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Sweating, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Sweating, Dose 2 | 5 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fever, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fever, Dose 2 | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fever, Dose 2 | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fatigue, Across Doses | 43 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fatigue, Across Doses | 2 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fatigue, Across Doses | 34 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any GI symptoms, Across Doses | 23 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 GI symptoms, Across Doses | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related GI symptoms, Across Doses | 15 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Headache, Across Doses | 30 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Headache, Across Doses | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Headache, Across Doses | 22 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Joint pain, Across Doses | 25 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Joint pain, Across Doses | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Joint pain, Across Doses | 16 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Muscle aches, Across Doses | 32 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Muscle aches, Across Doses | 4 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Muscle aches, Across Doses | 28 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Shivering, Across Doses | 13 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Shivering, Across Doses | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Shivering, Across Doses | 9 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Sweating, Across Doses | 16 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Sweating, Across Doses | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Sweating, Across Doses | 11 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fever, Across Doses | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fever, Across Doses | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fever, Across Doses | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Joint pain, Dose 2 | 7 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fatigue, Dose 1 | 33 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Sweating, Across Doses | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fatigue, Dose 1 | 39 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Headache, Across Doses | 27 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fatigue, Dose 1 | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Muscle aches, Dose 2 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any GI symptoms, Dose 1 | 12 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Shivering, Across Doses | 14 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 GI symptoms, Dose 1 | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Muscle aches, Dose 2 | 6 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related GI symptoms, Dose 1 | 5 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Headache, Across Doses | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Headache, Dose 1 | 20 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Shivering, Dose 2 | 5 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Headache, Dose 1 | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fever, Across Doses | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Headache, Dose 1 | 17 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Shivering, Dose 2 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Joint pain, Dose 1 | 16 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Headache, Across Doses | 20 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Joint pain, Dose 1 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Shivering, Dose 2 | 3 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Joint pain, Dose 1 | 14 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Shivering, Across Doses | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Muscle aches, Dose 1 | 20 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Sweating, Dose 2 | 8 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Muscle aches, Dose 1 | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Joint pain, Across Doses | 23 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Muscle aches, Dose 1 | 19 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Shivering, Dose 1 | 10 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Sweating, Dose 2 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Sweating, Across Doses | 14 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Shivering, Dose 1 | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Sweating, Dose 2 | 5 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Shivering, Dose 1 | 8 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Joint pain, Across Doses | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Sweating, Dose 1 | 16 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fever, Dose 2 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Sweating, Dose 1 | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Shivering, Across Doses | 10 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Sweating, Dose 1 | 10 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fever, Dose 2 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fever, Dose 1 | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Joint pain, Across Doses | 20 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fever, Dose 1 | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fever, Dose 2 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fever, Dose 1 | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fever, Across Doses | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fatigue, Dose 2 | 12 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fatigue, Across Doses | 43 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Muscle aches, Across Doses | 28 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fatigue, Dose 2 | 6 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Fatigue, Across Doses | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any GI symptoms, Dose 2 | 7 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Sweating, Across Doses | 19 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Muscle aches, Dose 2 | 12 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 GI symptoms, Dose 2 | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Fatigue, Across Doses | 37 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related GI symptoms, Dose 2 | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Muscle aches, Across Doses | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Headache, Dose 2 | 10 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any GI symptoms, Across Doses | 17 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Headache, Dose 2 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Fever, Across Doses | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Headache, Dose 2 | 3 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 GI symptoms, Across Doses | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Any Joint pain, Dose 2 | 11 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related Muscle aches, Across Doses | 24 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Grade 3 Joint pain, Dose 2 | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited General Adverse Events (AEs) | Related GI symptoms, Across Doses | 7 Subjects |
Secondary
Number of Subjects Reporting Solicited Local Adverse Events (AEs)
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. \> 100mm.
Time frame: Within 7 days (Days 0 - 6) after each dose and across doses.
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling, Across Doses (Pneumovax™23) | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Dose 1 (Influsplit™ Tetra) | 28 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain,Dose 1(Influsplit™ Tetra) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Dose 1 (Placebo) | 10 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Dose 1 (Placebo) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Dose 1 (Influsplit™ Tetra) | 3 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade3 Redness,Dose 1(Influsplit™ Tetra) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Dose 1 (Placebo) | 3 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Dose 1 (Placebo) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Dose1 (Influsplit™ Tetra) | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade3 Swelling,Dose1(Influsplit™ Tetra) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Dose 1 (Placebo) | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling, Dose 1 (Placebo) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Dose 2 (Pneumovax™ 23) | 63 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Dose 2 (Pneumovax™ 23) | 8 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Dose 2 (Pneumovax™ 23) | 8 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Dose 2 (Pneumovax™ 23) | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Dose 2 (Pneumovax™ 23) | 5 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling, Dose 2 (Pneumovax™ 23) | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Across Doses (Influsplit™ Tetra) | 28 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Across Doses (Influsplit™Tetra) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Across Doses (Placebo) | 10 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Across Doses (Placebo) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Across Doses (Pneumovax™ 23) | 63 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Across Doses (Pneumovax™ 23) | 8 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Across Doses (Influsplit™Tetra) | 3 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Across Doses (Influsplit™ Tetra) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Across Doses (Placebo) | 3 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Across Doses (Placebo) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Across Doses (Pneumovax™ 23) | 8 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Across Doses (Pneumovax™23) | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Across Doses (Influsplit™Tetra) | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling, Across Doses (Influsplit™Tetra) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Across Doses (Placebo) | 1 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling, Across Doses (Placebo) | 0 Subjects |
| Control Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Across Doses (Pneumovax™23) | 5 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Across Doses (Placebo) | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling, Across Doses (Influsplit™Tetra) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Dose 1 (Influsplit™ Tetra) | 58 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Across Doses (Influsplit™ Tetra) | 58 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain,Dose 1(Influsplit™ Tetra) | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Across Doses (Placebo) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Across Doses (Influsplit™Tetra) | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Dose 1 (Pneumovax™ 23) | 76 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Dose 1 (Pneumovax™ 23) | 6 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling, Across Doses (Pneumovax™23) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Dose 1 (Influsplit™ Tetra) | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Across Doses (Placebo) | 8 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade3 Redness,Dose 1(Influsplit™ Tetra) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Across Doses (Pneumovax™ 23) | 8 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Across Doses (Placebo) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Dose 1 (Pneumovax™ 23) | 8 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Dose 1 (Pneumovax™ 23) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Across Doses (Placebo) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Dose1 (Influsplit™ Tetra) | 3 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Across Doses (Pneumovax™ 23) | 76 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade3 Swelling,Dose1(Influsplit™ Tetra) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Across Doses (Pneumovax™23) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Across Doses (Pneumovax™ 23) | 6 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Dose 1 (Pneumovax™ 23) | 7 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling,Dose 1 (Pneumovax™ 23) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Pain, Dose 2 (Placebo) | 8 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Pain, Dose 2 (Placebo) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Across Doses (Pneumovax™23) | 7 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Across Doses (Influsplit™Tetra) | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Redness, Dose 2 (Placebo) | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Dose 2 (Placebo) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Across Doses (Influsplit™Tetra) | 3 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Redness, Across Doses (Influsplit™ Tetra) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Any Swelling, Dose 2 (Placebo) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling, Dose 2 (Placebo) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting Solicited Local Adverse Events (AEs) | Grade 3 Swelling, Across Doses (Placebo) | 0 Subjects |
Secondary
Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.
Time frame: Throughout the study period (Days 0-180)
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs) | Any MAE(s) | 37 Subjects |
| Control Group | Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs) | Related MAE(s) | 2 Subjects |
| Co-Ad Group | Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs) | Any MAE(s) | 43 Subjects |
| Co-Ad Group | Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs) | Related MAE(s) | 2 Subjects |
Secondary
Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination.
Time frame: During the entire study period (Days 0-180)
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs) | Any pIMD(s) | 0 Subjects |
| Control Group | Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs) | Related pIMD(s) | 0 Subjects |
| Co-Ad Group | Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs) | Any pIMD(s) | 1 Subjects |
| Co-Ad Group | Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs) | Related pIMD(s) | 0 Subjects |
Secondary
Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.
Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4. The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: At 28 days post-vaccination with Pneumovax™ 23
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 05 Ab.IgG5 (≥ 2) | 156 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 01 Ab.IgG (≥ 4) | 134 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 03 Ab.IgG (≥ 2) | 121 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 03 Ab.IgG (≥ 4) | 80 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 04 Ab.IgG (≥ 2) | 149 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 04 Ab.IgG (≥ 4) | 127 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 01 Ab.IgG (≥ 2) | 149 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 05 Ab.IgG5 (≥ 4) | 127 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 14 Ab.IgG (≥ 2) | 123 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 14 Ab.IgG (≥ 4) | 90 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 18C Ab.IgG (≥ 2) | 149 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 18C Ab.IgG (≥ 4) | 123 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 19A Ab.IgG (≥ 2) | 133 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 19A Ab.IgG (≥ 4) | 111 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 19F Ab.IgG (≥ 2) | 146 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 19F Ab.IgG (≥ 4) | 111 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 23F Ab.IgG (≥ 2) | 133 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 23F Ab.IgG (≥ 4) | 108 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 6B Ab.IgG (≥ 2) | 141 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 6B Ab.IgG (≥ 4) | 113 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 7F Ab.IgG (≥ 2) | 155 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 7F Ab.IgG (≥ 4) | 138 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 9V Ab.IgG (≥ 2) | 146 Subjects |
| Control Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 9V Ab.IgG (≥ 4) | 131 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 9V Ab.IgG (≥ 2) | 140 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 01 Ab.IgG (≥ 2) | 144 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 19A Ab.IgG (≥ 2) | 123 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 01 Ab.IgG (≥ 4) | 126 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 6B Ab.IgG (≥ 2) | 127 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 03 Ab.IgG (≥ 2) | 97 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 19A Ab.IgG (≥ 4) | 87 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 03 Ab.IgG (≥ 4) | 65 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 7F Ab.IgG (≥ 4) | 119 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 04 Ab.IgG (≥ 2) | 137 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 19F Ab.IgG (≥ 2) | 141 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 04 Ab.IgG (≥ 4) | 112 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 6B Ab.IgG (≥ 4) | 109 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 05 Ab.IgG5 (≥ 2) | 138 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 19F Ab.IgG (≥ 4) | 109 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 05 Ab.IgG5 (≥ 4) | 114 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 9V Ab.IgG (≥ 4) | 121 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 14 Ab.IgG (≥ 2) | 102 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 23F Ab.IgG (≥ 2) | 122 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 14 Ab.IgG (≥ 4) | 82 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 7F Ab.IgG (≥ 2) | 144 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 18C Ab.IgG (≥ 2) | 133 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 23F Ab.IgG (≥ 4) | 94 Subjects |
| Co-Ad Group | Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects. | Polysaccharide 18C Ab.IgG (≥ 4) | 116 Subjects |
Secondary
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).
Time frame: At Day 0 and Day 28
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria, Day 0 | 106 Subjects |
| Control Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2, Day 0 | 57 Subjects |
| Control Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria, Day 28 | 167 Subjects |
| Control Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1, Day 0 | 83 Subjects |
| Control Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata, Day 0 | 159 Subjects |
| Control Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2, Day 28 | 131 Subjects |
| Control Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata, Day 28 | 169 Subjects |
| Control Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1, Day 28 | 160 Subjects |
| Co-Ad Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata, Day 28 | 162 Subjects |
| Co-Ad Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1, Day 0 | 77 Subjects |
| Co-Ad Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2, Day 0 | 50 Subjects |
| Co-Ad Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2, Day 28 | 128 Subjects |
| Co-Ad Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria, Day 0 | 113 Subjects |
| Co-Ad Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria, Day 28 | 154 Subjects |
| Co-Ad Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata, Day 0 | 146 Subjects |
| Co-Ad Group | Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1, Day 28 | 157 Subjects |
Secondary
Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml. PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group. POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.
Time frame: At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 18C Ab.IgG (≥ 0.2 µg/ml) (PRE) | 154 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 7F Ab.IgG (≥ 0.2 µg/ml) (POST) | 165 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 9V Ab.IgG (≥ 0.05 µg/ml) (PRE) | 165 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 9V Ab.IgG (≥ 0.05 µg/ml) (POST) | 168 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 9V Ab.IgG (≥ 0.2 µg/ml) (PRE) | 123 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 9V Ab.IgG (≥ 0.2 µg/ml) (POST) | 166 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 14 Ab.IgG (≥ 0.05 µg/ml) (PRE) | 170 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 14 Ab.IgG (≥ 0.05 µg/ml) (POST) | 169 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 14 Ab.IgG (≥ 0.2 µg/ml) (PRE) | 168 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 14 Ab.IgG (≥ 0.2 µg/ml) (POST) | 168 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 18C Ab.IgG (≥ 0.05 µg/ml) (PRE) | 166 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 18C Ab.IgG (≥ 0.05 µg/ml) (POST) | 169 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 7F Ab.IgG (≥ 0.2 µg/ml) (PRE) | 127 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 18C Ab.IgG (≥ 0.2 µg/ml) (POST) | 168 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19A Ab.IgG (≥ 0.05 µg/ml) (PRE) | 168 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19A Ab.IgG (≥ 0.05 µg/ml) (POST) | 169 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19A Ab.IgG (≥ 0.2 µg/ml) (PRE) | 146 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19A Ab.IgG (≥ 0.2 µg/ml) (POST) | 165 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19F Ab.IgG (≥ 0.05 µg/ml) (PRE) | 169 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19F Ab.IgG (≥ 0.05 µg/ml) (POST) | 169 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19F Ab.IgG (≥ 0.2 µg/ml) (PRE) | 151 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19F Ab.IgG (≥ 0.2 µg/ml) (POST) | 169 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 23F Ab.IgG (≥ 0.05 µg/ml) (PRE) | 151 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 23F Ab.IgG (≥ 0.05 µg/ml) (POST) | 165 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 23F Ab.IgG (≥ 0.2 µg/ml) (PRE) | 112 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 23F Ab.IgG (≥ 0.2 µg/ml) (POST) | 155 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 01 Ab.IgG (≥ 0.05 µg/ml) (PRE) | 162 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 01 Ab.IgG (≥ 0.05 µg/ml) (POST) | 169 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 01 Ab.IgG (≥ 0.2 µg/ml) (PRE) | 112 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 01 Ab.IgG (≥ 0.2 µg/ml) (POST) | 167 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 03 Ab.IgG (≥ 0.05 µg/ml) (PRE) | 158 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 03 Ab.IgG (≥ 0.05 µg/ml) (POST) | 167 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 03 Ab.IgG (≥ 0.2 µg/ml) (PRE) | 114 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 03 Ab.IgG (≥ 0.2 µg/ml) (POST) | 158 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 04 Ab.IgG (≥ 0.05 µg/ml) (PRE) | 138 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 04 Ab.IgG (≥ 0.05 µg/ml) (POST) | 167 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 04 Ab.IgG (≥ 0.2 µg/ml) (PRE) | 77 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 04 Ab.IgG (≥ 0.2 µg/ml) (POST) | 158 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 05 Ab.IgG5 (≥ 0.05 µg/ml) (PRE) | 165 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 05 Ab.IgG5 (≥ 0.05 µg/ml) (POST) | 169 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 05 Ab.IgG5 (≥ 0.2 µg/ml) (PRE) | 130 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 05 Ab.IgG5 (≥ 0.2 µg/ml) (POST) | 163 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 6B Ab.IgG (≥ 0.05 µg/ml) (PRE) | 158 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 6B Ab.IgG (≥ 0.05 µg/ml) (POST) | 164 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 6B Ab.IgG (≥ 0.2 µg/ml) (PRE) | 106 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 6B Ab.IgG (≥ 0.2 µg/ml) (POST) | 157 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 7F Ab.IgG (≥ 0.05 µg/ml) (PRE) | 159 Subjects |
| Control Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 7F Ab.IgG (≥ 0.05 µg/ml) (POST) | 169 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 05 Ab.IgG5 (≥ 0.2 µg/ml) (POST) | 155 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 7F Ab.IgG (≥ 0.2 µg/ml) (PRE) | 130 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 23F Ab.IgG (≥ 0.2 µg/ml) (PRE) | 125 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 7F Ab.IgG (≥ 0.2 µg/ml) (POST) | 161 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 04 Ab.IgG (≥ 0.2 µg/ml) (PRE) | 82 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 9V Ab.IgG (≥ 0.05 µg/ml) (PRE) | 150 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 23F Ab.IgG (≥ 0.2 µg/ml) (POST) | 147 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 9V Ab.IgG (≥ 0.05 µg/ml) (POST) | 160 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 6B Ab.IgG (≥ 0.2 µg/ml) (PRE) | 110 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 9V Ab.IgG (≥ 0.2 µg/ml) (PRE) | 117 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 01 Ab.IgG (≥ 0.05 µg/ml) (PRE) | 152 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 9V Ab.IgG (≥ 0.2 µg/ml) (POST) | 157 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 04 Ab.IgG (≥ 0.2 µg/ml) (POST) | 149 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 14 Ab.IgG (≥ 0.05 µg/ml) (PRE) | 163 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 03 Ab.IgG (≥ 0.05 µg/ml) (POST) | 161 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 14 Ab.IgG (≥ 0.05 µg/ml) (POST) | 162 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 01 Ab.IgG (≥ 0.05 µg/ml) (POST) | 162 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 14 Ab.IgG (≥ 0.2 µg/ml) (PRE) | 160 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 6B Ab.IgG (≥ 0.05 µg/ml) (PRE) | 149 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 14 Ab.IgG (≥ 0.2 µg/ml) (POST) | 162 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 01 Ab.IgG (≥ 0.2 µg/ml) (PRE) | 118 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 18C Ab.IgG (≥ 0.05 µg/ml) (PRE) | 161 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 05 Ab.IgG5 (≥ 0.05 µg/ml) (PRE) | 159 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 18C Ab.IgG (≥ 0.05 µg/ml) (POST) | 162 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 01 Ab.IgG (≥ 0.2 µg/ml) (POST) | 159 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 18C Ab.IgG (≥ 0.2 µg/ml) (PRE) | 148 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 7F Ab.IgG (≥ 0.05 µg/ml) (POST) | 162 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 18C Ab.IgG (≥ 0.2 µg/ml) (POST) | 159 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 03 Ab.IgG (≥ 0.05 µg/ml) (PRE) | 149 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19A Ab.IgG (≥ 0.05 µg/ml) (PRE) | 160 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 05 Ab.IgG5 (≥ 0.05 µg/ml) (POST) | 162 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19A Ab.IgG (≥ 0.05 µg/ml) (POST) | 161 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 6B Ab.IgG (≥ 0.05 µg/ml) (POST) | 160 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19A Ab.IgG (≥ 0.2 µg/ml) (PRE) | 148 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 03 Ab.IgG (≥ 0.2 µg/ml) (PRE) | 121 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19A Ab.IgG (≥ 0.2 µg/ml) (POST) | 158 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 7F Ab.IgG (≥ 0.05 µg/ml) (PRE) | 154 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19F Ab.IgG (≥ 0.05 µg/ml) (PRE) | 160 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 03 Ab.IgG (≥ 0.2 µg/ml) (POST) | 153 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19F Ab.IgG (≥ 0.05 µg/ml) (POST) | 162 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 05 Ab.IgG5 (≥ 0.2 µg/ml) (PRE) | 115 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19F Ab.IgG (≥ 0.2 µg/ml) (PRE) | 152 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 04 Ab.IgG (≥ 0.05 µg/ml) (PRE) | 129 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 19F Ab.IgG (≥ 0.2 µg/ml) (POST) | 161 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 6B Ab.IgG (≥ 0.2 µg/ml) (POST) | 147 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 23F Ab.IgG (≥ 0.05 µg/ml) (PRE) | 151 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 04 Ab.IgG (≥ 0.05 µg/ml) (POST) | 158 Subjects |
| Co-Ad Group | Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Polysaccharide 23F Ab.IgG (≥ 0.05 µg/ml) (POST) | 159 Subjects |
Secondary
Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)
Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group. POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.
Time frame: At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 05 Ab.IgG5 (PRE) | 0.6 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 01 Ab.IgG (POST) | 5.5 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 03 Ab.IgG (PRE) | 0.4 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 03 Ab.IgG (POST) | 1.7 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 04 Ab.IgG (PRE) | 0.2 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 04 Ab.IgG (POST) | 2.3 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 01 Ab.IgG (PRE) | 0.4 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 05 Ab.IgG5 (POST) | 7.8 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 6B Ab.IgG (PRE) | 0.4 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 6B Ab.IgG (POST) | 3.9 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 7F Ab.IgG (PRE) | 0.6 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 7F Ab.IgG (POST) | 9.0 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 9V Ab.IgG (PRE) | 0.5 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 9V Ab.IgG (POST) | 5.9 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 14 Ab.IgG (PRE) | 3.7 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 14 Ab.IgG (POST) | 20.2 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 18C Ab.IgG (PRE) | 1.4 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 18C Ab.IgG (POST) | 13.5 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 19A Ab.IgG (PRE) | 1.3 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 19A Ab.IgG (POST) | 9.2 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 19F Ab.IgG (PRE) | 1.3 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 19F Ab.IgG (POST) | 11.9 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 23F Ab.IgG (PRE) | 0.4 Titers |
| Control Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 23F Ab.IgG (POST) | 3.1 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 23F Ab.IgG (PRE) | 0.5 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 01 Ab.IgG (PRE) | 0.4 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 9V Ab.IgG (PRE) | 0.5 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 01 Ab.IgG (POST) | 4.9 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 19A Ab.IgG (PRE) | 1.5 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 03 Ab.IgG (PRE) | 0.5 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 9V Ab.IgG (POST) | 4.4 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 03 Ab.IgG (POST) | 1.7 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 19F Ab.IgG (POST) | 10.6 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 04 Ab.IgG (PRE) | 0.2 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 14 Ab.IgG (PRE) | 2.9 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 04 Ab.IgG (POST) | 1.7 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 19A Ab.IgG (POST) | 7.7 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 05 Ab.IgG5 (PRE) | 0.5 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 14 Ab.IgG (POST) | 14.1 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 05 Ab.IgG5 (POST) | 5.7 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 23F Ab.IgG (POST) | 2.9 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 6B Ab.IgG (PRE) | 0.4 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 18C Ab.IgG (PRE) | 1.2 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 6B Ab.IgG (POST) | 3.1 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 19F Ab.IgG (PRE) | 1.4 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 7F Ab.IgG (PRE) | 0.7 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 18C Ab.IgG (POST) | 11.1 Titers |
| Co-Ad Group | Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) | Polysaccharide 7F Ab.IgG (POST) | 8.1 Titers |