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The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| >= 65-year age group-13vPnC | Experimental |
| |
| >= 65-year age group-23vPS | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Biological | A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). | One month after vaccination |
| Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination | For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. | One month after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Co.LTA PS Clinic | Fukuoka | Fukuoka | Japan | |||
| Seishinkai Inoue Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. |
| FG001 | 23vPS | 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 23-valent pneumococcal polysaccharide vaccine | Biological | A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1. |
|
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| One month after vaccination |
| Within 14 days after vaccination |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 37.5 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors. | Within 14 days after vaccination |
| Itoshima |
| Fukuoka |
| Japan |
| Yokohama Minoru Clinic | Yokohama | Kanagawa | Japan |
| Uzumasa Medical Clinic | Kyoto | Kyoto | Japan |
| Senbon Hospital | Osaka | Osaka | Japan |
| Oda Clinic | Shinjuku-ku | Tokyo | Japan |
| Sone Clinic | Shinjuku-ku | Tokyo | Japan |
| Medical Co. LTA Sumida Hospital | Sumida-ku | Tokyo | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. |
| BG001 | 23vPS | 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination | Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). | Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month after vaccination |
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| Primary | Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination | For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion. | Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with determinate fold rise of OPA antibody titer to serotype 6A. | Posted | Number | 95% Confidence Interval | percentage of participants | One month after vaccination |
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| Secondary | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination | Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). | Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype. | Posted | Geometric Mean | 95% Confidence Interval | titer | One month after vaccination |
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| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination | Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder). | Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after vaccination |
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| Other Pre-specified | Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination | Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 37.5 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors. | Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 14 days after vaccination |
|
AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 14 days after vaccination).
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1. | 1 | 382 | 211 | 382 | ||
| EG001 | 23vPS | 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1. | 0 | 382 | 166 | 382 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vaccination site pruritus | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Intercostal neuralgia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
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| Redness (Any) | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
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| Redness (Mild) | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
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| Redness (Moderate) | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
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| Redness (Severe) | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
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| Swelling (Any) | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
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| Swelling (Mild) | Skin and subcutaneous tissue disorders | Local Reaction | Systematic Assessment |
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| Swelling (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
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| Swelling (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
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| Pain (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
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| Pain (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
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| Pain (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
| |
| Pain (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
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| Limitation of arm movement (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
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| Limitation of arm movement (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
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| Limitation of arm movement (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
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| Limitation of arm movement (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment |
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| Fever >=37.5 to <38.5 degrees C | General disorders | Systemic Events | Systematic Assessment |
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| Fever >=38.5 to <39 degrees C | General disorders | Syetemic Events | Systematic Assessment |
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| Fever >=39 to <=40 degrees C | General disorders | Systemic Events | Systematic Assessment | All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors. |
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| Fever >40 degrees C | General disorders | Systemic Events | Systematic Assessment | All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors. |
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| Fatigue | General disorders | Systemic Events | Systematic Assessment |
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| Headache | General disorders | Systemic Events | Systematic Assessment |
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| Chills | General disorders | Systemic Events | Systematic Assessment |
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| Rash | General disorders | Systemic Events | Systematic Assessment |
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| Vomiting | General disorders | Systemic Events | Systematic Assessment |
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| Decreased appetite | General disorders | Systemic Events | Systematic Assessment |
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| New muscle pain | General disorders | Systemic Events | Systematic Assessment |
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| Aggravated muscle pain | General disorders | Systemic Events | Systematic Assessment |
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| New joint pain | General disorders | Systemic Events | Systematic Assessment |
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| Aggravated joint pain | General disorders | Systemic Events | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
Not provided
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| Male |
|
| 4 (n=360, 362) |
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| 5 (n=350, 361) |
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| 6B (n=360, 359) |
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| 7F (n=365, 364) |
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| 9V (n=365,358) |
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| 14 (n=363, 359) |
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| 18C (n=366, 362) |
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| 19A (n=365, 362) |
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| 19F (n=352, 357) |
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| 23F (n=366, 363) |
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Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). |
| GMT Ratio |
| 0.7 |
| 2-Sided |
| 95 |
| 0.59 |
| 0.89 |
| Yes |
| Non-Inferiority or Equivalence |
Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 2.6 | 2-Sided | 95 | 1.96 | 3.44 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 2.9 | 2-Sided | 95 | 2.22 | 3.86 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 1.4 | 2-Sided | 95 | 1.10 | 1.75 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 1.4 | 2-Sided | 95 | 1.12 | 1.74 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 2.3 | 2-Sided | 95 | 1.59 | 3.24 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 1.0 | 2-Sided | 95 | 0.77 | 1.23 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 2.1 | 2-Sided | 95 | 1.61 | 2.86 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 2.3 | 2-Sided | 95 | 1.81 | 2.92 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 2.0 | 2-Sided | 95 | 1.42 | 2.79 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
| Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). | GMT Ratio | 2.5 | 2-Sided | 95 | 1.84 | 3.49 | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5. |
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| Participants |
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| Units | Counts |
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| Participants |
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