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The purpose of this study was to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HZ/su Group | Experimental | Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2. |
|
| Placebo Group | Placebo Comparator | Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HZ/su | Biological | Two doses of the HZ/su vaccine administered intramuscularly, one each at Day 1 and Month 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE) | A participant with vaccine response for anti-gE was defined as a participant with:
| At 1 month post-Dose 2 of study intervention administration (Month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) and Between-group GMC Ratios | Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL). | At 1 month post-Dose 2 of study intervention administration (Month 3) |
Not provided
Inclusion Criteria:
Participants and/or participant's legally acceptable representative(s) (LAR) who in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the participant and/or participant's LAR(s) after the study has been explained according to local regulatory requirements and prior to performance of any study-specific procedure.
A male or female aged 50 YOA or older at the time of the first study intervention.
Healthy participants or medically stable patients as established by medical history and clinical examination before entering into the study.
Female participants of non-childbearing potential may be enrolled in the study.
Female participants of childbearing potential may be enrolled in the study, if the participant:
Exclusion Criteria:
Medical conditions
Prior/Concomitant therapy
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before first dose and ending 30 days after the last dose of study intervention administration with the exception of licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to Dose 1 and/or Dose 2 and/or at least 14 days after any dose of study intervention.
[In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is recommended and/or organised by the public health authorities, outside the routine immunisation programme, the time period described above can be reduced if necessary for that vaccine provided it is used according to local governmental recommendations and that the Sponsor is notified accordingly.]
Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/ invasive medical device).
Other exclusions
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Visakhapatnam | Andhra Pradesh | India | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39923547 | Background | Naficy A, Chugh Y, Tariq M, Hawksworth H, Sankhe LR, Mwakingwe-Omari A. Immune response and safety of the adjuvanted recombinant zoster vaccine in adults 50 years of age and older in India: A randomized phase 3 trial. Vaccine. 2025 Mar 19;50:126819. doi: 10.1016/j.vaccine.2025.126819. Epub 2025 Feb 10. | |
| 37781954 | Derived |
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Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
All 288 participants enrolled in this study received 2 doses of the study interventions and were included in the Exposed Set. A total of 285 participants completed the study.
The study was conducted at 9 centers in India.
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| ID | Title | Description |
|---|---|---|
| FG000 | HZ/suSeq Group | Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2. |
| FG001 | Placebo Group | Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HZ/suSeq Group | Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2. |
| BG001 | Placebo Group | Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2. |
| 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 | Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE) | A participant with vaccine response for anti-gE was defined as a participant with:
| This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time point post-Dose 2. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 1 month post-Dose 2 of study intervention administration (Month 3) |
|
Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
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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 | HZ/suSeq Group | Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental poisoning | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2022 | Oct 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2022 | Oct 11, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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Data was collected in an observer-blind manner.
| Placebo | Drug | Two doses of Placebo (lyophilised sucrose reconstituted with saline [NaCl] solution) administered intramuscularly, one each at Day 1 and Month 2. |
|
| Percentage of Participants Reporting Solicited Administration Site Events | The assessed solicited administration site events included injection site erythema, pain, pruritus and swelling. | Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2) |
| Percentage of Participants Reporting Solicited Systemic Events | The assessed solicited systemic events included fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and shivering. | Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2) |
| Percentage of Participants Reporting Unsolicited Adverse Events (AEs) | An unsolicited AE was defined as an AE that was not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who had signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. | Within 30 days after any study intervention dose administration (vaccine/placebo administered at Day 1 and Month 2) |
| Percentage of Participants Reporting Serious Adverse Events (SAEs) | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes. | From Dose 1 (Day 1) up to 30 days post-last study intervention dose |
| Percentage of Participants Reporting Potential Immune-mediated Diseases (pIMDs) | pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology. | From Dose 1 (Day 1) up to 30 days post-last study intervention dose |
| Percentage of Participants Reporting SAEs | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes. | From Dose 1 (Day 1) up to study end (Month 8) |
| Percentage of Participants Reporting pIMDs | pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology. | From Dose 1 (Day 1) up to study end (Month 8) |
| Anti-gE Antibody Concentrations Expressed as GMCs | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3) |
| Percentage of Participants Seropositive for Anti-gE Antibodies | A participant seropositive for anti-gE antibodies was defined as a participant whose antibody concentration was greater than or equal to (>=) the assay cut-off value (97 mIU/mL). | At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3) |
| Mean Geometric Increase (MGI) of Anti-gE Antibody Concentrations | MGI was defined as the geometric mean of the within participant ratios of anti-gE antibody concentration at 1 month post-Dose 2 (Month 3) compared to pre-study intervention administration (Day 1) anti-gE antibody concentration. | At 1 month post-Dose 2 of study intervention administration (Month 3) compared to pre-study intervention administration (Day 1) |
| North Guwāhāti |
| Assam |
| 781031 |
| India |
| GSK Investigational Site | Ahmedabad | Gujarat | 380005 | India |
| GSK Investigational Site | Mumbai | Maharashtra | India |
| GSK Investigational Site | Chandigarh | Punjab | 160012 | India |
| GSK Investigational Site | Kanpur | 208002 | India |
| GSK Investigational Site | Mysore | 570004 | India |
| GSK Investigational Site | New Delhi | 110060 | India |
| GSK Investigational Site | Pune | 412216 | India |
| de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 | HZ/suSeq Group | Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2. |
| OG001 | Placebo Group | Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2. |
|
|
| Secondary | Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) and Between-group GMC Ratios | Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL). | This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time point post-Dose 2. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At 1 month post-Dose 2 of study intervention administration (Month 3) |
|
|
|
|
| Secondary | Percentage of Participants Reporting Solicited Administration Site Events | The assessed solicited administration site events included injection site erythema, pain, pruritus and swelling. | This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention and with the diary cards completed post-each study intervention dose. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2) |
|
|
|
| Secondary | Percentage of Participants Reporting Solicited Systemic Events | The assessed solicited systemic events included fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and shivering. | This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention and with the diary cards completed post-each study intervention dose. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2) |
|
|
|
| Secondary | Percentage of Participants Reporting Unsolicited Adverse Events (AEs) | An unsolicited AE was defined as an AE that was not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who had signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. | This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 30 days after any study intervention dose administration (vaccine/placebo administered at Day 1 and Month 2) |
|
|
|
| Secondary | Percentage of Participants Reporting Serious Adverse Events (SAEs) | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes. | This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 (Day 1) up to 30 days post-last study intervention dose |
|
|
|
| Secondary | Percentage of Participants Reporting Potential Immune-mediated Diseases (pIMDs) | pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology. | This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 (Day 1) up to 30 days post-last study intervention dose |
|
|
|
| Secondary | Percentage of Participants Reporting SAEs | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes. | This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 (Day 1) up to study end (Month 8) |
|
|
|
| Secondary | Percentage of Participants Reporting pIMDs | pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology. | This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 (Day 1) up to study end (Month 8) |
|
|
|
| Secondary | Anti-gE Antibody Concentrations Expressed as GMCs | Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL. | This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time points pre- and post-Dose 2. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3) |
|
|
|
| Secondary | Percentage of Participants Seropositive for Anti-gE Antibodies | A participant seropositive for anti-gE antibodies was defined as a participant whose antibody concentration was greater than or equal to (>=) the assay cut-off value (97 mIU/mL). | This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time points pre- and post-Dose 2. | Posted | Number | 95% Confidence Interval | Percentage of participants | At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3) |
|
|
|
| Secondary | Mean Geometric Increase (MGI) of Anti-gE Antibody Concentrations | MGI was defined as the geometric mean of the within participant ratios of anti-gE antibody concentration at 1 month post-Dose 2 (Month 3) compared to pre-study intervention administration (Day 1) anti-gE antibody concentration. | This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time points pre- and post-Dose 2. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At 1 month post-Dose 2 of study intervention administration (Month 3) compared to pre-study intervention administration (Day 1) |
|
|
|
| 0 |
| 143 |
| 1 |
| 143 |
| 103 |
| 143 |
| EG001 | Placebo Group | Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2. | 0 | 145 | 2 | 145 | 88 | 145 |
| Head injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
|
| Administration site erythema | General disorders | MedDRA v26.0 | Systematic Assessment |
|
| Administration site pain | General disorders | MedDRA v26.0 | Systematic Assessment |
|
| Administration site swelling | General disorders | MedDRA v26.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA v26.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA v26.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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.
| D007239 | Infections |
| Erythema, post-Dose 2 |
|
|
| Erythema, Across doses |
|
|
| Pain, post-Dose 1 |
|
|
| Pain, post-Dose 2 |
|
|
| Pain, Across doses |
|
|
| Pruritus, post-Dose 1 |
|
|
| Pruritus, post-Dose 2 |
|
|
| Pruritus, Across doses |
|
|
| Swelling, post-Dose 1 |
|
|
| Swelling, post-Dose 2 |
|
|
| Swelling, Across doses |
|
|
| Fatigue, post-Dose 2 |
|
|
| Fatigue, Across doses |
|
|
| Fever, post-Dose 1 |
|
|
| Fever, post-Dose 2 |
|
|
| Fever, Across doses |
|
|
| Gastrointestinal symptoms, post-Dose 1 |
|
|
| Gastrointestinal symptoms, post-Dose 2 |
|
|
| Gastrointestinal symptoms, Across doses |
|
|
| Headache, post-Dose 1 |
|
|
| Headache, post-Dose 2 |
|
|
| Headache, Across doses |
|
|
| Myalgia, post-Dose 1 |
|
|
| Myalgia, post-Dose 2 |
|
|
| Myalgia, Across doses |
|
|
| Shivering, post-Dose 1 |
|
|
| Shivering, post-Dose 2 |
|
|
| Shivering, Across doses |
|
|