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The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSL425 (15 mcg) | Experimental | 15 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21 |
|
| CSL425 (30 mcg) | Experimental | 30 mcg of hemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSL425 | Biological | CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination | HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. | Before and 21 days after the first vaccination |
| HI Antibody Titre Seroconversion Rate After the Second Vaccination | HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. | Before and 21 days after the second vaccination |
| Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination | GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. | Before and 21 days after the first vaccination |
| GMFI in the HI Antibody Titre After the Second Vaccination | GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. | Before and 21 days after the second vaccination |
| Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination | 21 days after the first vaccination | |
| Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Director Vaccines | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Westmead | New South Wales | 2145 | Australia | ||
| Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20026597 | Result | Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010 Jan 6;303(1):37-46. doi: 10.1001/jama.2009.1911. Epub 2009 Dec 21. |
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One randomized participant withdrew consent prior to vaccine administration and was not included in the participant flow data or in any analysis population.
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| ID | Title | Description |
|---|---|---|
| FG000 | CSL425 (15 mcg) Cohort A | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| FG001 | CSL425 (30 mcg) Cohort A | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| FG002 | CSL425 (15 mcg) Cohort B | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| FG003 | CSL425 (30 mcg) Cohort B | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CSL425 (15 mcg) Cohort A | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| BG001 | CSL425 (30 mcg) Cohort A |
| 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 | Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination | HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. | The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | Before and 21 days after the first vaccination |
|
For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA V13.0", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.
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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 | CSL425 (15 mcg) Cohort A | Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Disclosure Manager | Seqirus | 1-855-358-8966 | Seqirus.ClinicalTrials@Seqirus.com |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| CSL425 |
| Biological |
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free |
|
| 21 days after the second vaccination |
| During the 7 days after each vaccination |
| Duration of Solicited AEs After the First Vaccination | Solicited AEs included AEs that were specifically sought for. | During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7. |
| Duration of Solicited AEs After the Second Vaccination | Solicited AEs included AEs that were specifically sought for. | During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7. |
| Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma). | Up to 180 days after the last vaccination |
| Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities. | During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs |
| Brisbane |
| Queensland |
| 4006 |
| Australia |
| Study Site | North Adelaide | South Australia | 5006 | Australia |
| Study Site | Carlton | Victoria | 3010 | Australia |
| Study Site | Subiaco | Western Australia | 6027 | Australia |
| Withdrew Consent |
|
| Dose 2 contraindicated |
|
| Declined further vaccination |
|
| Refused - pyrexia after Dose 1 |
|
| Viral illness after Dose 1 |
|
| Diagnosed with H1N1 |
|
Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| BG002 | CSL425 (15 mcg) Cohort B | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| BG003 | CSL425 (30 mcg) Cohort B | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
| OG001 | CSL425 (30 mcg) Cohort A | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| OG002 | CSL425 (15 mcg) Cohort B | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
| OG003 | CSL425 (30 mcg) Cohort B | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. |
|
|
| Primary | HI Antibody Titre Seroconversion Rate After the Second Vaccination | HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre. | The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | Before and 21 days after the second vaccination |
|
|
|
| Primary | Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination | GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. | The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Geometric Mean | 95% Confidence Interval | geometric mean fold increase | Before and 21 days after the first vaccination |
|
|
|
| Primary | GMFI in the HI Antibody Titre After the Second Vaccination | GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre. | The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Geometric Mean | 95% Confidence Interval | geometric mean fold increase | Before and 21 days after the second vaccination |
|
|
|
| Primary | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination | The Evaluable Population (for the first vaccination) comprised all randomised participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | 21 days after the first vaccination |
|
|
|
| Primary | Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination | The Evaluable Population (for the second vaccination) comprised all randomised participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3). | Posted | Number | 95% Confidence Interval | percentage of participants | 21 days after the second vaccination |
|
|
|
| Secondary | Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination | Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | During the 7 days after each vaccination |
|
|
|
| Secondary | Duration of Solicited AEs After the First Vaccination | Solicited AEs included AEs that were specifically sought for. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Mean | Standard Deviation | days | During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7. |
|
|
|
| Secondary | Duration of Solicited AEs After the Second Vaccination | Solicited AEs included AEs that were specifically sought for. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Mean | Standard Deviation | days | During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7. |
|
|
|
| Secondary | Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs) | An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma). | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | Up to 180 days after the last vaccination |
|
|
|
| Secondary | Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination | Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities. | The Safety Population comprised all participants who received at least one dose of the vaccine and provided follow-up safety data. | Posted | Number | percentage of participants | During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs |
|
|
|
| 4 |
| 82 |
| 81 |
| 82 |
| EG001 | CSL425 (30 mcg) Cohort A | Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | 1 | 80 | 78 | 80 |
| EG002 | CSL425 (15 mcg) Cohort B | Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | 1 | 103 | 91 | 103 |
| EG003 | CSL425 (30 mcg) Cohort B | Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. | 1 | 104 | 96 | 104 |
| Convulsion | Nervous system disorders | MedDRA V13.0 | Systematic Assessment |
|
| Kawasaki's disease | Vascular disorders | MedDRA V13.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA V13.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA V13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA V13.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA V13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V13.0 | Systematic Assessment |
|
| Influenza-like illness | General disorders | MedDRA V13.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA V13.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA V13.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA V13.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA V13.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA V13.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA V13.0 | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA V13.0 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA V13.0 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA V13.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA V13.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA V13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA V13.0 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA V13.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA V13.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA V13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA V13.0 | Systematic Assessment |
|
| Pain at Injection Site | General disorders | Systematic Assessment |
|
| Redness at Injection Site | General disorders | Systematic Assessment |
|
| Swelling/Induration at Injection Site | General disorders | Systematic Assessment |
|
| Nausea/Vomiting | General disorders | Systematic Assessment |
|
| Diarrhoea | General disorders | Systematic Assessment |
|
| Loss of Appetite | General disorders | Systematic Assessment | Not solicited for in Cohort B. |
|
| Irritability | General disorders | Systematic Assessment | Not solicited for in Cohort B. |
|
| Fever | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment | Not solicited for in Cohort A. |
|
| Muscle Ache (Myalgia) | General disorders | Systematic Assessment | Not solicited for in Cohort A. |
|
| Malaise | General disorders | Systematic Assessment | Not solicited for in Cohort A. |
|
CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Any pain at injection site |
|
| Grade 3 pain at injection site |
|
| Any redness at injection site |
|
| Grade 3 redness at injection site |
|
| Any swelling/induration at injection site |
|
| Grade 3 swelling/induration at injection site |
|
| Any solicited systemic AE |
|
| Any nausea/vomiting |
|
| Grade 3 nausea/vomiting |
|
| Any diarrhoea |
|
| Grade 3 diarrhoea |
|
| Any loss of appetite |
|
| Grade 3 loss of appetite |
|
| Any irritability |
|
| Grade 3 irritability |
|
| Any fever |
|
| Grade 3 fever |
|
| Any headache |
|
| Grade 3 headache |
|
| Any muscle ache |
|
| Grade 3 muscle ache |
|
| Any malaise |
|
| Grade 3 malaise |
|
| Redness at injection site |
|
| Swelling/induration at injection site |
|
| Nausea/vomiting |
|
| Diarrhoea |
|
| Loss of appetite |
|
| Irritability |
|
| Fever |
|
| Headache |
|
| Muscle ache |
|
| Malaise |
|
| Redness at injection site |
|
| Swelling/induration at injection site |
|
| Nausea/vomiting |
|
| Diarrhoea |
|
| Loss of appetite |
|
| Irritability |
|
| Fever |
|
| Headache |
|
| Muscle ache |
|
| Malaise |
|
| Related SAE |
|
| At least one AESI |
|
| Related AESI |
|
| At least one NOCI |
|
| Related NOCI |
|
| Grade 1 unsolicited AE |
|
| Grade 2 unsolicited AE |
|
| Grade 3 unsolicited AE |
|