Study: NCT03926728

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522-CAF01 IM
Description: 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-Lok™ 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522-CAF01 IM
Description: 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-Lok™ 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522-CAF01 IM
Description: 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-Lok™ 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522-CAF01 IM
Description: 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-Lok™ 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522-CAF09b IM
Description: 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-Lok™ 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522 ID
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522 TO
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522 TO
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522 TO
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522 TO
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CTH522 TO
Description: 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.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo (Saline)
Description: Placebo only given as IM, ID and TO.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo (Saline)
Description: Placebo only given as IM, ID and TO.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo (Saline)
Description: Placebo only given as IM, ID and TO.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo (Saline)
Description: Placebo only given as IM, ID and TO.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Placebo (Saline)
Description: Placebo only given as IM, ID and TO.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo (Saline)
Description: Placebo only given as IM, ID and TO.