Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011434-10 | EudraCT Number |
Not provided
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| Name | Class |
|---|---|
| Premier Research | OTHER |
Not provided
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The purpose of this study was to determine the efficacy of NewGam in preventing serious bacterial infections and to determine the pharmacokinetic profile of NewGam. The safety of NewGam and its effect on quality of life were also evaluated.
NewGam is a new 10% human normal immunoglobulin (IVIG) solution developed by Octapharma for intravenous administration. It is supplied as a liquid formulation ready to use. The primary therapeutic use of immunoglobulins is to provide antibodies to prevent viral and bacterial diseases (replacement therapy). IVIG has proved to be useful in a variety of clinical conditions other than for replacement of immunoglobulins; IVIG exhibits an immunomodulatory effect. Children and adults with a Primary Immunodeficiency Disease (PID) have an increased risk of recurrent bacterial and viral infections that typically attack the respiratory tract (sinusitis, bronchitis, pneumonia) but can also affect the gastrointestinal tract (gastroenteritis). Theses diseases can be severe and can lead to substantial morbidity. Responses to antibacterial therapy are often poor. At present, most primary immune deficiencies are not curable, but IVIGs have been shown to decrease the total number of severe infections and the duration of hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NewGam | Experimental | Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NewGam | Biological | The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as minimum trough levels of serum immunoglobulin G (IgG) was above 5 g/L. If serum IgG trough levels dropped to 5 g/L or less, the dose was to be adjusted at the investigator's discretion. NewGam was supplied as a solution for infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Bacterial Infections Per Person-year of Treatment | The number of serious bacterial infections per person-year of treatment was calculated by the following formula: Total number of serious bacterial infections / patient-years on NewGam treatment. Serious bacterial infections were defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess. | Baseline to end of the study (up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| IgG Trough Level Concentration | Total IgG trough concentrations were measured in serum samples taken before each infusion. | Baseline to end of the study (up to 12 months) |
| Trough Level Concentration of Antibodies Against Haemophilus Influenzae |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sudir Gupta, MD | Irvine | California | United States | |||
| Isaac Melamed, MD |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NewGam | Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Total set: All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NewGam | Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Serious Bacterial Infections Per Person-year of Treatment | The number of serious bacterial infections per person-year of treatment was calculated by the following formula: Total number of serious bacterial infections / patient-years on NewGam treatment. Serious bacterial infections were defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess. | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Number | Serious infections per person-year of tr | Baseline to end of the study (up to 12 months) |
|
Not provided
Safety analysis set: All participants who received at least part of 1 treatment with NewGam.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NewGam | Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gout | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine | Octapharma USA | 201 604-1155 | michael.eppolito@octapharma.com |
Not provided
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
Not provided
Not provided
Not provided
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|
|
Trough level concentrations of antibodies against Haemophilus influenzae were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants.
| Baseline to end of the study (up to 12 months) |
| Trough Level Concentration of Antibodies Against Measles | Trough level concentrations of antibodies against measles were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Baseline to end of the study (up to 12 months) |
| Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae | Trough level concentrations of antibodies against Streptococcus pneumoniae (serotypes types 6B, 14, 9V, 18C, 19F, 4, and 23F) were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Baseline to end of the study (up to 12 months) |
| Trough Level Concentration of Antibodies Against Cytomegalovirus | Trough level concentrations of antibodies against cytomegalovirus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Baseline to end of the study (up to 12 months) |
| Trough Level Concentration of Antibodies Against Tetanus | Trough level concentrations of antibodies against tetanus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Baseline to end of the study (up to 12 months) |
| Trough Level Concentration of Antibodies Against Varicella-zoster Virus | Trough level concentrations of antibodies against varicella-zoster virus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Baseline to end of the study (up to 12 months) |
| Total Number of Infections | The number of infections included serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, osteomyelitis/septic arthritis, visceral abscess, bacterial meningitis) and other infections. For other infections, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term was used to determine the type of infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified. | Baseline to end of the study (up to 12 months) |
| Number of Non-serious Infections | The MedDRA preferred term was used to determine the type of non-serious infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified. The total number of infections and the number in each category are reported. | Baseline to end of the study (up to 12 months) |
| Time to Resolution of Serious and Other Infections | Since infections were reported as adverse events, the time to resolution of an infection was the time from the start date of the infection adverse event to the end date of the infection adverse event. | Baseline to end of the study (up to 12 months) |
| Percentage of Participants Treated With Antibiotics | The total percentage of participants treated with antibiotics, as well as, the percentage of participants treated with antibiotics therapeutically and prophylactically are reported. | Baseline to end of the study (up to 12 months) |
| Number of Antibiotic Treatment Episodes Per Person-year of Treatment | The number of antibiotic treatment episodes per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment episodes / patient-years of NewGam treatment. | Baseline to end of the study (up to 12 months) |
| Number of Antibiotic Treatment Days Per Person-year of Treatment | The number of antibiotic treatment days per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment days / patient-years of NewGam treatment. | Baseline to end of the study (up to 12 months) |
| Number of Participants Hospitalized Due to an Infection | Baseline to end of the study (up to 12 months) |
| Percentage of Participants With at Least 1 Episode of Fever | Baseline to end of the study (up to 12 months) |
| Percentage of Participants That Missed School or Work Due to an Infection | Baseline to end of the study (up to 12 months) |
| Changes in the Physical and Psychosocial Child Health Questionnaire-Parent Form Scores From Baseline to the End of the Study | The Quality of Life (QoL) questionnaire Child Health Questionnaire-Parent Form (CHQ-PF50) was completed by a parent or guardian in study participants < 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates more positive functioning or better health status. A positive change score indicates improvement. | Baseline to end of the study (up to 12 months) |
| Changes in the Physical and Mental Short Form-36 Health Survey Scores From Baseline to the End of the Study | The Quality of Life (QoL) questionnaire Short Form-36 Health Survey (SF-36-HS) was completed by participants ≥ 14 years of age. The SF-36-HS consists of 36 items organized into 8 subscales. The 8 subscales could be combined into 2 summary scores, physical and mental. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates better health. A positive change score indicates improvement. | Baseline to end of the study (up to 12 months) |
| Centennial |
| Colorado |
| United States |
| James Moy, MD | Chicago | Illinois | United States |
| William Smits, MD | Fort Wayne | Indiana | United States |
| Dr. Alan Knutsen | St Louis | Missouri | 63104 | United States |
| Ai Lan Kobayashi, MD | Papillion | Nebraska | United States |
| Hans Ochs, MD | Seattle | Washington | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | IgG Trough Level Concentration | Total IgG trough concentrations were measured in serum samples taken before each infusion. | Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels. | Posted | Mean | Standard Deviation | g/L | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Trough Level Concentration of Antibodies Against Haemophilus Influenzae | Trough level concentrations of antibodies against Haemophilus influenzae were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels. | Posted | Mean | Standard Deviation | µg/mL | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Trough Level Concentration of Antibodies Against Measles | Trough level concentrations of antibodies against measles were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels. | Posted | Mean | Standard Deviation | mIU/mL | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Trough Level Concentration of Antibodies Against Streptococcus Pneumoniae | Trough level concentrations of antibodies against Streptococcus pneumoniae (serotypes types 6B, 14, 9V, 18C, 19F, 4, and 23F) were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels. | Posted | Mean | Standard Deviation | µg/mL | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Trough Level Concentration of Antibodies Against Cytomegalovirus | Trough level concentrations of antibodies against cytomegalovirus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels. | Posted | Mean | Standard Deviation | U | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Trough Level Concentration of Antibodies Against Tetanus | Trough level concentrations of antibodies against tetanus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels. | Posted | Mean | Standard Deviation | IU/mL | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Trough Level Concentration of Antibodies Against Varicella-zoster Virus | Trough level concentrations of antibodies against varicella-zoster virus were measured in serum blood samples collected before the 1st infusion in all participants, before the 9th and 10th infusions in participants receiving NewGam every 3 weeks, before the 7th and 8th infusions in participants receiving NewGam every 4 weeks, and at the termination visit for all participants. | Pharmacokinetic set: All participants who had concentration data for at least 1 of the pre-infusion IgG trough levels. | Posted | Mean | Standard Deviation | U/mL | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Total Number of Infections | The number of infections included serious bacterial infections (bacterial pneumonia, bacteraemia/sepsis, osteomyelitis/septic arthritis, visceral abscess, bacterial meningitis) and other infections. For other infections, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term was used to determine the type of infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified. | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Number | Infections | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Number of Non-serious Infections | The MedDRA preferred term was used to determine the type of non-serious infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified. The total number of infections and the number in each category are reported. | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Number | Infections | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Time to Resolution of Serious and Other Infections | Since infections were reported as adverse events, the time to resolution of an infection was the time from the start date of the infection adverse event to the end date of the infection adverse event. | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Mean | Standard Deviation | Days | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Percentage of Participants Treated With Antibiotics | The total percentage of participants treated with antibiotics, as well as, the percentage of participants treated with antibiotics therapeutically and prophylactically are reported. | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Number | Percentage of participants | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Number of Antibiotic Treatment Episodes Per Person-year of Treatment | The number of antibiotic treatment episodes per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment episodes / patient-years of NewGam treatment. | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Number | Treatment episodes/person/year | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Number of Antibiotic Treatment Days Per Person-year of Treatment | The number of antibiotic treatment days per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment days / patient-years of NewGam treatment. | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Number | Treatment days/person/year | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Number of Participants Hospitalized Due to an Infection | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Number | Participants | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Percentage of Participants With at Least 1 Episode of Fever | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Number | Percentage of participants | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Percentage of Participants That Missed School or Work Due to an Infection | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Number | Percentage of participants | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Changes in the Physical and Psychosocial Child Health Questionnaire-Parent Form Scores From Baseline to the End of the Study | The Quality of Life (QoL) questionnaire Child Health Questionnaire-Parent Form (CHQ-PF50) was completed by a parent or guardian in study participants < 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates more positive functioning or better health status. A positive change score indicates improvement. | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to end of the study (up to 12 months) |
|
|
|
| Secondary | Changes in the Physical and Mental Short Form-36 Health Survey Scores From Baseline to the End of the Study | The Quality of Life (QoL) questionnaire Short Form-36 Health Survey (SF-36-HS) was completed by participants ≥ 14 years of age. The SF-36-HS consists of 36 items organized into 8 subscales. The 8 subscales could be combined into 2 summary scores, physical and mental. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates better health. A positive change score indicates improvement. | Full analysis set: All participants who received at least 1 complete treatment with NewGam and for whom data on infections were available from at least 1 post-treatment diary entry. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to end of the study (up to 12 months) |
|
|
|
| 5 |
| 51 |
| 45 |
| 51 |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Septoplasty | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Octapharma agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Octapharma supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. Octapharma also reserves the right to review data prior to publishing and provide comments/changes within a certain time period.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Termination visit - serotype 6B |
|
| Infusion 1 - serotype 9V |
|
| Termination visit - serotype 9V |
|
| Infusion 1 - serotype 14 |
|
| Termination visit - serotype 14 |
|
| Infusion 1 - serotype 18C |
|
| Termination visit - serotype 18C |
|
| Infusion 1 - serotype 19F |
|
| Termination visit - serotype 19F |
|
| Infusion 1 - serotype 23F |
|
| Termination visit - serotype 23F |
|
| Title | Measurements |
|---|---|
|
| Infections of the gastrointestinal tract |
|
| Infections of the genitourinary tract |
|
| Upper respiratory tract infections |
|
| Lower respiratory tract infections |
|
| Infections of the skin |
|
| Infections not elsewhere classified |
|