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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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CHLM-02 was a phase I, double-blind, randomized, placebo-controlled trial of the chlamydia vaccine CTH522. 65 trial participants were randomized into 12 groups and six cohorts (A1 to F2). Cohorts A to E received three intramuscular (IM) injections of CTH522 (Day 0, 28, and 112). Cohorts A to D received CTH522 adjuvanted with Cationic Adjuvant Formulation (CAF®) 01 IM in two doses (85µg [A to C] or 15µg [D]). Cohort E received 85µg CTH522 adjuvanted with CAF®09b. Cohorts B and C received unadjuvanted CTH522 boost via the topic ocular (TO) or intradermal (ID) route, respectively, jointly with the second and third IM vaccinations. Cohort F received placebo. The effect of mucosal recall on eye immunity with TO CTH522 or placebo was assessed Day 140.
This trial was a phase I, double-blind, parallel, randomised, and placebo-controlled trial of the chlamydia vaccine CTH522 in healthy adults.
It was planned to randomize 66 subjects but only 65 subjects were randomized. Cohorts A-D investigated CTH522-CAF01 administered IM in two doses (85 mcg and 15 mcg). Cohort E investigated CTH522-CAF09b administered IM in one dose (85 mcg). Cohort F was the placebo group. The enrolled subjects were to complete 12 trial visits. All subjects in the active cohorts (cohort A-E) were to receive three IM injections of the adjuvanted CTH522 and some (cohort B and C) were to receive the non-adjuvanted CTH522 via the TO or ID route (given at the same time as the 2nd and 3rd IM vaccinations). All active cohorts were to receive TO administration as a boost at Day 140 of either the non-adjuvanted CTH522 (12 mcg in each eye) or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A 85 mcg CTH522-CAF01 | Experimental | Cohort A received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort A1 receives placebo at Day 28, 112, and 140, while cohort A2 received placebo at Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140. |
|
| Cohort B 85 mcg CTH522-CAF01 + TO CTH522 | Experimental | Cohort B received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort B1 received TO vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while cohort B2 received the same for Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140. |
|
| Cohort C 85 mcg CTH522-CAF01 + ID CTH522 | Experimental | Cohort C received three IM vaccination of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort C1 received ID vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while cohort C2 received the same for Day 28 and 112, but TO CTH522 boost at Day 140. |
|
| Cohort D 15 mcg CTH522-CAF01 | Experimental | Cohort D received three IM vaccination of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). This cohort was divided into two groups: Cohort D1 received TO placebo given on Day 28, 112, and 140, while cohort D2 received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTH522-CAF01 IM | Biological | On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lokâ„¢ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited Local Injection Site Reactions | Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth. | Visit 2 (Day 0) plus 14 Days |
| Solicited Local Injection Site Reactions | Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth. | Visit 4 (Day 28) plus 14 Days |
| Solicited Local Injection Site Reactions | Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth. | Visit 7 (Day 112) plus 14 Days |
| Solicited Local Ocular Reactions | Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort. | Visit 4 (Day 28) plus 14 Days |
| Solicited Local Ocular Reactions | Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort. | Visit 7 (Day 112) plus 14 Days |
| Solicited Local Ocular Reactions |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity (4-fold Increase From Baseline) | Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations. | Day 14, 28, 42, 56, 112, 126, 140, 154, 238 |
| Immunogenicity (10-fold Increase From Baseline) |
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Inclusion Criteria:
IC1: Healthy males and females between 18-45 years old on the day of the first vaccination.
IC2: Has been properly informed about the trial and signed the consent form.
IC3: Is willing and likely to comply with trial procedures.
IC4: Is prepared to grant authorised persons access to his/her trial-related medical record.
IC5: Is willing to use acceptable contraceptive measures during the trial (two weeks before and two weeks after the trial). Heterosexually active female capable of becoming pregnant must agree to use hormonal contraception, intrauterine device, intrauterine hormone releasing system, or to complete abstinence from at least two weeks before the first vaccination until at least two weeks after the last. Complete abstinence (defined as refraining from heterosexual intercourse) must be in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), withdrawal and progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, are not acceptable methods of contraception.
Exclusion criteria:
EX1: Is positive for C. trachomatis via urine PCR or has a known history of C. trachomatis.
EX2: Is positive for gonorrhoea via urine PCR test, or HIV, hepatitis B/C, syphilis via blood tests.
EX3: Has a significant active disease such as cardiac, liver, immunological, neurological, psychiatric, or clinically significant abnormality of haematological or biochemical parameters.
EX4: Has BMI ≥ 35 kg/m2.
EX5: Is currently participating in another clinical trial with an investigational or noninvestigational drug or device, or was treated with an investigational drug within 28 days before the first vaccination.
EX6: Has received, or plans to receive, any immunisation within 14 days of the start of the trial or during the trial immunisations.
EX7: Is currently receiving treatment with systemic immunosuppressive agents. Topical steroids are allowed unless applied to the IM or ID injection site.
EX8: Has a condition which in the opinion of the investigator is not suitable for participation in the trial.
EX9: Is known or confirmed to have an allergy to any of the vaccine constituents.
EX10: Is unable to refrain from the use of contact lenses. Contact lenses should be avoided two days before TO administration and for seven days later (longer if any ongoing local eye AE).
EX11: Has any evident ocular disease upon ophthalmoscopic exam at screening or any medical history of ocular disease that, in the opinion of the investigator, may impact the subject's participation in the trial.
EX12: Is pregnant (positive pregnancy test) or breastfeeding or not willing to use contraception during the trial.
EX13: Has confirmed a history of pelvic inflammatory disease or significant gynaecological diseases.
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| Name | Affiliation | Role |
|---|---|---|
| Alvaro Borges, MD | Statens Serum Institut | Study Director |
| Katrina Pollock, MD | Imperial Clinical Research Facility Hammersmith Hospital | Principal Investigator |
| Lina S Stoey, MPH | Statens Serum Institut | Study Chair |
| Pernille N Tingskov, BS | Statens Serum Institut | Study Chair |
| Rebecca B Dohn, Pharm | Statens Serum Institut | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIHR Imperial Center for Translational and Experimental Medicine | London | W12 | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38615673 | Derived | Pollock KM, Borges AH, Cheeseman HM, Rosenkrands I, Schmidt KL, Sondergaard RE, Day S, Evans A, McFarlane LR, Joypooranachandran J, Amini F, Skallerup P, Dohn RB, Jensen CG, Olsen AW, Bang P, Cole T, Schronce J, Lemm NM, Kristiansen MP, Andersen PL, Dietrich J, Shattock RJ, Follmann F. An investigation of trachoma vaccine regimens by the chlamydia vaccine CTH522 administered with cationic liposomes in healthy adults (CHLM-02): a phase 1, double-blind trial. Lancet Infect Dis. 2024 Aug;24(8):829-844. doi: 10.1016/S1473-3099(24)00147-6. Epub 2024 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140. |
| FG001 | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. |
| FG002 | Cohort B1 85 mcg IM CTH522-CAF01+ TO CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. |
| FG003 | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140. |
| FG004 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. |
| FG005 | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. |
| FG006 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. |
| FG007 | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. |
| FG008 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. |
| FG009 | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. |
| FG010 | Cohort F1 IM Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. |
| FG011 | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140. |
| BG001 | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Solicited Local Injection Site Reactions | Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth. | Posted | Count of Participants | Participants | Visit 2 (Day 0) plus 14 Days |
|
Up to 238 days after first vaccination
The safety analysis set included all subjects who were randomised and exposed to at least one dosage of the study vaccine including subjects who were withdrawn after exposure to the study vaccine.
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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 | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
Screening and recruitment activities had to be paused during the trial due to the Covid-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Per Skallerup | Statens Serum Institut | +4532688554 | PRSK@SSI.dk |
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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 | Dec 14, 2020 | Aug 1, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2022 | Aug 1, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014141 | Trachoma |
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Cohort E 85 mcg CTH522-CAF09b | Experimental | Cohort E received three IM vaccination of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). This cohort was divided into two groups: Cohort E1 received TO placebo given on Day 28, 112, and 140, while cohort E2 received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. |
|
| Cohort F Placebo | Placebo Comparator | Cohort F received three IM vaccinations of placebo in form of 0.9% NaCl saline (Day 0, 28, and 112).This cohort was divided into two groups: Cohort F1 received TO placebo given on Day 28, 112, and 140, while cohort F2 received ID placebo given on Day 28 and 112 and TO placebo on Day 140. |
|
|
| CTH522-CAF09b IM | Biological | On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF09b. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lokâ„¢ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial. |
|
| CTH522 ID | Biological | 24 mcg CTH522 given ID is in the non-dominant deltoid muscle. ID with a 1 mL syringe via a 26-28 gauge needle using a NanoPass device or similar. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial. |
|
| CTH522 TO | Biological | 24 mcg CTH522 (12 mcg in each eye) TO administrations will be performed using a Gilson positive displacement pipette. The identity of vaccine will be known to the clinical site staff dispensing/administrating the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial. |
|
| Placebo (Saline) | Biological | Placebo only given as IM, ID and TO. |
|
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
| Visit 9 (Day 140) plus 14 Days |
| Solicited Systemic Reactions | Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature > 38.3°C, chills, myalgia, and rash. | Visit 2 (Day 0) plus 14 Days |
| Solicited Systemic Reactions | Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature > 38.3°C, chills, myalgia, and rash. | Visit 4 (Day 28) plus 14 Days |
| Solicited Systemic Reactions | Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature > 38.3°C, chills, myalgia, and rash. | Visit 7 (Day 112) plus 14 Days |
Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
| Day 14, 28, 42, 56, 112, 126, 140, 154, 238 |
Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. |
| BG002 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. |
| BG003 | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140. |
| BG004 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. |
| BG005 | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. |
| BG006 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. |
| BG007 | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. |
| BG008 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. |
| BG009 | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. |
| BG010 | Cohort F1 IM Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. |
| BG011 | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140. |
| BG012 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG002 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. |
| OG003 | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140. |
| OG004 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. |
| OG005 | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. |
| OG006 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140. |
| OG007 | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. |
| OG008 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28,112, and 140. |
| OG009 | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. |
| OG010 | Cohort F1 IM Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. |
| OG011 | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28 ,and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140. |
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| Primary | Solicited Local Injection Site Reactions | Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth. | Percentages calculated from number of participants vaccinated on Day 28. | Posted | Count of Participants | Participants | Visit 4 (Day 28) plus 14 Days |
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| Primary | Solicited Local Injection Site Reactions | Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth. | Percentages calculated from number of participants vaccinated on Day 112 | Posted | Count of Participants | Participants | Visit 7 (Day 112) plus 14 Days |
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| Primary | Solicited Local Ocular Reactions | Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort. | Percentages calculated from number of participants vaccinated on Day 28 | Posted | Count of Participants | Participants | Visit 4 (Day 28) plus 14 Days |
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| Primary | Solicited Local Ocular Reactions | Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort. | Percentages calculated from number of participants vaccinated on Day 112 | Posted | Count of Participants | Participants | Visit 7 (Day 112) plus 14 Days |
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| Primary | Solicited Local Ocular Reactions | Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort. | Percentages calculated from number of participants vaccinated on Day 140 | Posted | Count of Participants | Participants | Visit 9 (Day 140) plus 14 Days |
|
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| Primary | Solicited Systemic Reactions | Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature > 38.3°C, chills, myalgia, and rash. | Percentages calculated from number of participants vaccinated on Day 0 | Posted | Count of Participants | Participants | Visit 2 (Day 0) plus 14 Days |
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| Primary | Solicited Systemic Reactions | Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature > 38.3°C, chills, myalgia, and rash. | Percentages calculated from number of participants vaccinated on Day 28 | Posted | Count of Participants | Participants | Visit 4 (Day 28) plus 14 Days |
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| Primary | Solicited Systemic Reactions | Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature > 38.3°C, chills, myalgia, and rash. | Percentages calculated from number of participants vaccinated on Day 112 | Posted | Count of Participants | Participants | Visit 7 (Day 112) plus 14 Days |
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| Secondary | Immunogenicity (4-fold Increase From Baseline) | Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations. | Frequency of 4-fold increase seroconversion for anti-CTH522 IgG - full analysis set | Posted | Count of Participants | Participants | Day 14, 28, 42, 56, 112, 126, 140, 154, 238 |
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|
|
| Secondary | Immunogenicity (10-fold Increase From Baseline) | Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations. | Posted | Count of Participants | Participants | Day 14, 28, 42, 56, 112, 126, 140, 154, 238 |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. | 0 | 9 | 0 | 9 | 9 | 9 |
| EG002 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140. | 0 | 9 | 0 | 9 | 9 | 9 |
| EG004 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. | 0 | 9 | 0 | 9 | 9 | 9 |
| EG006 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG007 | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. | 0 | 9 | 0 | 9 | 9 | 9 |
| EG008 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG009 | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. | 0 | 9 | 0 | 9 | 9 | 9 |
| EG010 | Cohort F1 IM Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG011 | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140. | 0 | 3 | 0 | 3 | 3 | 3 |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Deafness bilateral | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ear congestion | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eyelid irritation | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Swelling of eyelid | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal rigidity | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site movement impairment | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site paraesthesia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Campylobacter infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Gonorrhoea | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Haemoglobin increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Mean cell volume decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pubic pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
Not provided
| D007239 | Infections |
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D017670 |
| Sodium Compounds |
| Injection site warmth |
|
| Injection site erythema |
|
| Injection site pruritus |
|
| Injection site swelling |
|
| Injection site erythema |
|
| Injection site warmth |
|
| Injection site swelling |
|
| Injection site pruritus |
|
| Lacrimation increased |
|
| Ocular hyperaemia |
|
| Swelling of eyelid |
|
| Fisher Exact |
| 0.3956 |
| Other |
| Ocular hyperaemia |
|
| Lacrimation increased |
|
| Fisher Exact |
| 0.3956 |
| Other |
| Lacrimation increased |
|
| Ocular hyperaemia |
|
| Swelling of eyelid |
|
| Chills |
|
| Pyrexia |
|
| Rash |
|
Comparison: Cohort A-C [A1, A2, B1, B2, C1, C2] vs E [E1, E2]. |
| Fisher Exact |
| 1 |
Simple nonparametric statistical test. |
| Other |
| Comparison: Cohort A-C [A1, A2, B1, B2, C1, C2] vs F [F1, F2]. | Fisher Exact | 0.3229 | Other |
| Chills |
|
| Rash |
|
| Pyrexia |
|
| chills |
|
| Day 28 |
|
| Day 42 |
|
| Day 56 |
|
| Day 112 |
|
| Day 126 |
|
| Day 140 |
|
| Day 154 |
|
| Day 238 |
|
| Day 28 |
|
| Day 42 |
|
| Day 56 |
|
| Day 112 |
|
| Day 126 |
|
| Day 140 |
|
| Day 154 |
|
| Day 238 |
|