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The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13vPnC+TIV Followed by Placebo 1 month later | Experimental |
| |
| Placebo+TIV Followed by 13vPnC 1 month later | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Biological | Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later. |
| Measure | Description | Time Frame |
|---|---|---|
| TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) | Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared. | Baseline and 1 month after TIV vaccination |
| 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) | IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. | 1 month after 13vPnC vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pre-specified Local Reactions | Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder). |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
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A total of 1185 participants were enrolled, of which 1160 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC+TIV Followed by Placebo 1 Month Later | Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later. |
| FG001 | Placebo+TIV Followed by 13vPnC 1 Month Later | Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC+TIV Followed by Placebo 1 Month Later | Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Data for participants in the safety population (ie. those who received at least 1 dose of study vaccine) are presented. The number of participants equals the number receiving Dose 1 in the Participant Flow section (1152), minus 1 participant in the "13vPnC+TIV followed by placebo 1 month later" group who received a regimen that was not part of the study. |
| 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 | TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) | Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared. | Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and 1 month after TIV vaccination |
|
AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).
SAEs were grouped by organ system, with number and frequency of events summarized. Non-serious AEs were summarized in a similar manner and included solicited AEs collected in the e-diary (systematic assessment) and unsolicited events collected on the case report form at each visit (non-systematic 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+TIV | Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Redness (any) = present at site of vaccination |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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|
| 13vPnC + TIV | Biological | Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later. |
|
| Days 1 through 14 after 13vPnC vaccination |
| Percentage of Participants With Pre-specified Systemic Events | Systemic events (Any fever >= 38 degrees Celsius [C]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category. | Days 1 through 14 after 13vPnC vaccination |
| Other |
|
| Death |
|
| Adverse Event |
|
| Failed to return |
|
| Lost to Follow-up |
|
| Placebo+TIV Followed by 13vPnC 1 Month Later |
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Data for participants in the safety population (ie. those who received at least 1 dose of study vaccine) are presented. The number of participants equals the number receiving Dose 1 in the Participant Flow section (1152), minus 1 participant in the "13vPnC+TIV followed by placebo 1 month later" group who received a regimen that was not part of the study. | Count of Participants | Participants |
|
| OG001 |
| Placebo+TIV |
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM. |
|
|
|
| Primary | 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) | IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. | Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 1 month after 13vPnC vaccination |
|
|
|
|
| Other Pre-specified | Percentage of Participants With Pre-specified Local Reactions | Local reactions were reported using an electronic diary. Pain was scaled as Any; Mild (awareness but easily tolerated); Moderate (discomfort enough to interfere with usual activity) and Severe (incapacitating the usual activity). Redness and swelling were scaled as Any; Mild (2.5 cm to 5.0 cm); Moderate (5.1 to 10.0 cm)and Severe (> 10.0 cm). Limitation in arm movement were scaled as Any; Mild (some limitation); Moderate (unable to move above head but able to move above shoulder) and Severe (unable to move above shoulder). | Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively. | Posted | Number | percentage of participants | Days 1 through 14 after 13vPnC vaccination |
|
|
|
| Other Pre-specified | Percentage of Participants With Pre-specified Systemic Events | Systemic events (Any fever >= 38 degrees Celsius [C]), fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, any aggravated muscle pain, new joint pain or any aggravated joint pain. Participants may be presented in more than one category. | Safety population: included all participants who received at least 1 dose of study vaccine. n=number of participants at each timepoint, in each group respectively. | Posted | Number | Percentage of participants | Days 1 through 14 after 13vPnC vaccination |
|
|
|
| Post-Hoc | 13vPnC Comparisons: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) | Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of a subset of participants using a microcolony OPA (mcOPA) assay. | Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. n= number of participants with a determinate OPA antibody titer to the given serotype. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titers | 1 month after 13vPnC vaccination |
|
|
|
|
| 4 |
| 576 |
| 307 |
| 576 |
| EG001 | Placebo | Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM [13vPnC + TIV]). | 8 | 559 | 194 | 559 |
| EG002 | Placebo+TIV | Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM. | 0 | 575 | 256 | 575 |
| EG003 | 13vPnC | Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM [Placebo + TIV]). | 5 | 558 | 237 | 558 |
| Cardiac failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Endoscopy small intestine | Investigations | MedDRA | Non-systematic Assessment |
|
| Electrocardiogram ST segment elevation | Investigations | MedDRA | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
|
| Redness (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Redness (mild) = 2.5 to 5.0 cm |
|
| Redness (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Redness (moderate) = 5.1 to 10.0 cm |
|
| Redness (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Redness (severe) = >10.0 cm |
|
| Swelling (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Swelling (any) = present at site of vaccination |
|
| Swelling (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Swelling (mild) = 2.5 to 5.0 cm |
|
| Swelling (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Swelling (moderate) = 5.1 to 10.0 cm |
|
| Swelling (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Swelling (severe) = >10.0 cm |
|
| Pain (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Pain (any) = present at site of vaccination |
|
| Pain (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Pain (mild) = awareness of symptoms but easily tolerated |
|
| Pain (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Pain (moderate) = discomfort enough to cause interference with usual activity |
|
| Pain (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Pain (severe) = unable to move above shoulder |
|
| Limitation of arm movement (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Limitation of arm movement (any) = present |
|
| Limitation of arm movement (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Limitation of arm movement (mild) = some limitation |
|
| Limitation of arm movement (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Limitation of arm movement (moderate) = unable to move above head but able to move above shoulder |
|
| Limitation of arm movement (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Limitation of arm movement (severe) = unable to move above shoulder |
|
| Fever ≥ 38 degrees C but < 38.5 degrees C | General disorders | Systemic events | Systematic Assessment |
|
| Fever ≥ 38.5 degrees C but < 39 degrees C | General disorders | Systemic events | Systematic Assessment |
|
| Fever ≥ 39 degrees C but ≤ 40.0 degrees C | General disorders | Systemic events | Systematic Assessment |
|
| Fever > 40.0 degrees C | General disorders | Systemic events | Systematic Assessment |
|
| Fatigue | General disorders | Systemic events | Systematic Assessment |
|
| Headache | General disorders | Systemic events | Systematic Assessment |
|
| Chills | General disorders | Systemic events | Systematic Assessment |
|
| Rash | General disorders | Systemic events | Systematic Assessment |
|
| Vomiting | General disorders | Systemic events | Systematic Assessment |
|
| Decreased appetite | General disorders | Systemic events | Systematic Assessment |
|
| New muscle pain | General disorders | Systemic events | Systematic Assessment |
|
| Any aggravated muscle pain | General disorders | Systemic events | Systematic Assessment |
|
| New joint pain | General disorders | Systemic events | Systematic Assessment |
|
| Any aggravated joint pain | General disorders | Systemic events | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
|
| Sensation of foreign body | General disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Eyelid infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Total lung capacity decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Nephrocalcinosis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Bartholin's cyst | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Diaphragmatic hernia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Dental prosthesis user | Social circumstances | MedDRA | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA | Non-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.
| D007239 | Infections |
| Serotype 4 |
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| Serotype 5 |
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| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
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| Serotype 9V |
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| Serotype 14 |
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| Serotype 18C |
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| Serotype 19A |
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| Serotype 19F |
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| Serotype 23F |
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| Serotype 3. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.94 | 2-Sided | 95 | 0.78 | 1.13 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 4. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.66 | 2-Sided | 95 | 0.51 | 0.87 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 5. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.69 | 2-Sided | 95 | 0.55 | 0.86 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 6A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.76 | 2-Sided | 95 | 0.61 | 0.94 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 6B. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.97 | 2-Sided | 95 | 0.75 | 1.25 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 7F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.84 | 2-Sided | 95 | 0.67 | 1.07 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 9V. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.80 | 2-Sided | 95 | 0.63 | 1.02 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 14. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.72 | 2-Sided | 95 | 0.53 | 0.97 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 18C. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.80 | 2-Sided | 95 | 0.64 | 1.01 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 19A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.70 | 2-Sided | 95 | 0.56 | 0.87 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 19F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.65 | 2-Sided | 95 | 0.49 | 0.85 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Serotype 23F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | Ratio of GMCs | 0.95 | 2-Sided | 95 | 0.71 | 1.27 | CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion). |
| Redness: Moderate (n= 433, 424) |
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| Redness: Severe (n= 429, 420) |
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| Swelling: Any (n= 441, 431) |
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| Swelling: Mild (n= 440, 430) |
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| Swelling: Moderate (n= 432, 423) |
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| Swelling: Severe (n= 428, 420) |
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| Pain: Any (n= 480, 470) |
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| Pain: Mild (n= 470, 462) |
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| Pain: Moderate (n= 447, 442) |
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| Pain: Severe (n= 429, 421) |
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| Limitation of arm movement: Any (n= 445, 432) |
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| Limitation of arm movement: Mild (n= 444, 432) |
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| Limitation of arm movement:Moderate (n= 430, 420) |
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| Limitation of arm movement: Severe (n= 429, 420) |
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| Any local reaction (n= 488, 470) |
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| Fever >=39degreesC but <=40.0degreesC (n=428,420) |
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| Fever >40.0 degrees C (n= 429, 422) |
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| Fatigue (n= 476, 456) |
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| Headache (n= 472, 449) |
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| Chills (n= 443, 429) |
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| Rash (n= 433, 427) |
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| Vomiting (n= 432, 424) |
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| Decreased appetite (n= 450, 434) |
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| New muscle pain (n= 468, 448) |
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| Any aggravated muscle pain (n= 454, 439) |
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| New joint pain (n= 452, 435) |
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| Any aggravated joint pain (n= 452, 428) |
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| Any systemic event (n= 510, 488) |
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| Serotype 4 (n= 247, 245) |
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| Serotype 5 (n= 245, 234) |
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| Serotype 6A (n= 250, 252) |
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| Serotype 6B (n= 259, 248) |
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| Serotype 7F (n= 246, 248) |
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| Serotype 9V (n= 247, 242) |
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| Serotype 14 (n= 247, 236) |
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| Serotype 18C (n= 250, 244) |
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| Serotype 19A (n= 251, 247) |
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| Serotype 19F (n= 247, 242) |
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| Serotype 23F (n= 252, 242) |
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| Serotype 3. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.9 | 2-Sided | 95 | 0.69 | 1.20 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 4. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.7 | 2-Sided | 95 | 0.47 | 0.95 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 5. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 1.1 | 2-Sided | 95 | 0.77 | 1.60 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 6A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.8 | 2-Sided | 95 | 0.54 | 1.08 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 6B. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.8 | 2-Sided | 95 | 0.55 | 1.09 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 7F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.7 | 2-Sided | 95 | 0.47 | 1.12 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 9V. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.7 | 2-Sided | 95 | 0.42 | 1.03 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 14. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.9 | 2-Sided | 95 | 0.65 | 1.24 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 18C. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.8 | 2-Sided | 95 | 0.59 | 1.14 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 19A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.8 | 2-Sided | 95 | 0.61 | 1.12 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 19F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.8 | 2-Sided | 95 | 0.57 | 1.16 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |
| Serotype 23F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693. | GMT Ratio | 0.8 | 2-Sided | 95 | 0.54 | 1.27 | 2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results. | Yes | Non-Inferiority or Equivalence | The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion). |