Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults

VRC 322/DMID 21-0016: A Phase I, Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05398796

Enrollment

Registered

2022-06-01

Start date

2022-07-11

Completion date

2024-09-17

Last updated

2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nipah Virus Infection

Keywords

mRNA Vaccine, Pandemic Threat, First in Human, Zoonotic Transmission

Brief summary

Background: Nipah virus (NiV) is transmitted from animals to humans, from humans to humans, and through contaminated food. Infected people may have a cough and trouble breathing. Some people may develop serious symptoms, such as brain infection and inflammation, that can lead to death. There are no drugs or vaccines to treat or prevent NiV infection. Objective: To test the safety of an experimental vaccine (mRNA-1215) for NiV. Researchers will also evaluate how participants bodies respond to the vaccine. Eligibility: Healthy, nonpregnant adults aged 18 to 60 years. Design: Participants visited the NIH clinic 13 to 15 times over 14 to 16 months. Participants received 2 doses of the experimental vaccine at 1 month apart. The vaccine was given as a shot into the muscle of the upper arm. Participants stayed in the clinic at least 30 minutes after each vaccination. Participants were given a diary card and a thermometer. They recorded their temperature and any other reactogenicity symptoms for 7 days after each vaccination. During each follow-up visit, 3 to 14 tubes of blood were drawn for research. Some participants underwent an optional procedure called apheresis. A needle is placed into a vein in each arm. Blood is removed through one needle. The blood passed through a machine that separates some of the blood cells. The rest of the blood is returned to the body through another needle. The mRNA-1215 vaccine cannot cause NiV infection.

Detailed description

Design: This Phase I, dose escalation, open label clinical trial was the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability, and immunogenicity of a Nipah virus (NiV) mRNA vaccine. The hypotheses were that the vaccine would be safe, tolerable, and would elicit an immune response in healthy adults. Study Product: The investigational mRNA-1215 vaccine is a lipid nanoparticle dispersion containing mRNA that encodes for a secreted prefusion stabilized F component covalently linked to a G monomer (PreF/G) of a NiV Malaysian 1999 strain with a trimerization domain resulting in secretion of a trimer of heterodimers. mRNA-1215 was co-developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Disease (NIAID) and ModernaTX, Inc, and manufactured by ModernaTX. Participants: Healthy adults, 18 to 60 years of age. Plan: Participants were enrolled at the NIH Clinical Center and received mRNA-1215 via intramuscular (IM) injection by needle and syringe into the deltoid muscle. A dose escalation safety evaluation occurred to ensure the safety data support proceeding to the higher dose groups. The mRNA-1215 vaccine dose for Group 4 was selected based on interim analysis of safety and immunogenicity data from Groups 1-3. Participants were evaluated for safety and immune responses through clinical observation and blood collection for safety labs at specified timepoints throughout the study. The study schema was as follows: Study Schema Group Participants Dose/Route Day 0 Week 4 1. 10 25 mcg IM X X 2. 10 50 mcg IM X X 3. 10 100 mcg IM X X 4. 10 10 mcg IM X X Total \*\*40 \*\*Enrollment of up to 50 subjects was permitted in case additional evaluations were required for safety or immunogenicity. Duration: Participants were evaluated for safety and immune responses throughout the study for 52 weeks following the second vaccine dose.

Interventions

BIOLOGICALmRNA -1215

mRNA-1215 is a lipid nanoparticle dispersion containing mRNA that encodes for a secreted prefusion stabilized F component covalently linked to a G monomer (PreF/G) of a NiV Malaysian 1999 strain

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* INCLUSION CRITERIA: A volunteer must meet all of the following criteria: 1. Healthy adults between the ages of 18-60 years inclusive. 2. Based on history and physical examination, in good general health and without history of any of the conditions listed in the

Exclusion criteria

. 3. Able and willing to complete the informed consent process. 4. Available for clinic visits for 52 weeks after last product administration. 5. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 6. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) of 18 to 35 within the 56 days prior to enrollment. Laboratory Criteria within 56 days before enrollment: 7. White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval. 8. Total lymphocyte count \>= 800 cells/microL. 9. Platelets = 125,000 - 500,000 cells/microL. 10. Hemoglobin within institutional normal range or accompanied by the PI or designee approval. 11. Alanine aminotransferase (ALT) \<= 1.25 X institutional upper limit of normal (ULN). 12. Aspartate aminotransferase (AST) \<= 1.25 X institutional ULN. 13. Alkaline phosphatase (ALP) \<1.1 X institutional ULN. 14. Total bilirubin within institutional normal range or accompanied by the PI or designee approval. 15. Serum creatinine \<= 1.1 X institutional ULN. 16. Negative for HIV infection by an FDA-approved method of detection Criteria applicable to women of childbearing potential: 17. Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment. 18. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	Day 0 after product administration through Day 392, up to Week 56	Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized\*. Safety lab parameters included pregnancy test, hematology and chemistry labs, and HIV Serology diagnostic test. Institutional lab normal ranges as well as Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration	Day 0 after product administration through Day 392, up to Week 56	An AESI is an AE (serious or nonserious) of scientific medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor is required.
Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	First vaccination to 6 months	MAAEs are defined as adverse events leading to hospitalization, an emergency room visit or an otherwise unscheduled visit to or from medical personnel, for any reason.
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	7 days after product administration	Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	7 days after product administration	Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Number of Participants With Serious Adverse Events Following Product Administration	Day 0 after product administration through Day 392, up to Week 56	SAEs were recorded from receipt of product administration through the last study visit at Week 56. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Day 0 through 28 days post product administration, up to Week 4	Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Number of Participants With New Chronic Medical Conditions Following Product Administration	Day 0 after product administration through Day 392, up to Week 56	New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit through Day 392, up to Week 56. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity

Secondary

Measure	Time frame	Description
Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).	Vaccine-induced binding antibody titers against G antigen of Nipah virus Malaysia strain (NiV(M)) were measured by ELISA. The value of the antibody response was determined by obtaining half of the maximum effective concentration (EC50) titer from the optical density 450 nm curves for the function of the reciprocal dilution using a four-parameter logistic curve fit in Prism (version 10.2.2). NiV G EC50 titers were normalized using the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) international standard (IS, NIBSC code 22/130) and are reported as group geometric mean titers (GMTs) and 95% confidence intervals (CIs) in international units per milliliter (IU/ml).
Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).	Vaccine-induced binding antibody titers against Pre-F antigen of Nipah virus Malaysia strain (NiV(M)) were measured by ELISA. The value of the antibody response was determined by obtaining half of the maximum effective concentration (EC50) titer from the optical density 450 nm curves for the function of the reciprocal dilution using a four-parameter logistic curve fit in Prism (version 10.2.2). NiV Pre-F EC50 titers were normalized using the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) international standard (IS, NIBSC code 22/130) and are reported as group geometric mean titers (GMTs) and 95% confidence intervals (CIs) in international units per milliliter (IU/ml).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Group 1 mRNA -1215: 25 mcg IM, 2 injections 4 weeks apart	10
Group 2 mRNA -1215: 50 mcg IM, 2 injections 4 weeks apart	10
Group 3 mRNA -1215: 100 mcg IM, 2 injections 4 weeks apart	10
Group 4 mRNA -1215: 10 mcg IM, 2 injections 4 weeks apart	10
Total	40

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Participant moved from the area	0	1	0	0

Baseline characteristics

Characteristic	Group 2	Group 3	Group 4	Group 1	Total
Age, Continuous	40.9 years STANDARD_DEVIATION 11.1	36.2 years STANDARD_DEVIATION 13.1	38.5 years STANDARD_DEVIATION 11.1	33.9 years STANDARD_DEVIATION 6.5	37.4 years STANDARD_DEVIATION 10.6
Age, Customized 18-20	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized 21-30	2 Participants	5 Participants	3 Participants	3 Participants	13 Participants
Age, Customized 31-40	2 Participants	2 Participants	2 Participants	4 Participants	10 Participants
Age, Customized 41-50	4 Participants	0 Participants	5 Participants	3 Participants	12 Participants
Age, Customized 51-60	2 Participants	3 Participants	0 Participants	0 Participants	5 Participants
Body Mass Index (BMI) 18.5-24.9	6 Participants	3 Participants	5 Participants	1 Participants	15 Participants
Body Mass Index (BMI) 25.0-29.9	2 Participants	5 Participants	2 Participants	7 Participants	16 Participants
Body Mass Index (BMI) 30.0-35	2 Participants	2 Participants	3 Participants	2 Participants	9 Participants
Body Mass Index (BMI) Missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Body Mass Index (BMI) Under 18.5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Body Mass Index (BMI), Mean	25.4 kg/m^2 STANDARD_DEVIATION 3.5	26.2 kg/m^2 STANDARD_DEVIATION 4.1	27.1 kg/m^2 STANDARD_DEVIATION 4.4	27.4 kg/m^2 STANDARD_DEVIATION 2.9	26.5 kg/m^2 STANDARD_DEVIATION 3.7
Education Advanced degree	3 Participants	5 Participants	5 Participants	7 Participants	20 Participants
Education College/University	6 Participants	5 Participants	5 Participants	3 Participants	19 Participants
Education High school graduate/GED	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Education Less than high school graduate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Education Not Collected	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants	10 Participants	9 Participants	10 Participants	38 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
NIH Employee Declined to Respond	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
NIH Employee No	7 Participants	6 Participants	5 Participants	5 Participants	23 Participants
NIH Employee Yes	3 Participants	4 Participants	5 Participants	5 Participants	17 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	3 Participants	1 Participants	0 Participants	2 Participants	6 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	2 Participants	1 Participants	5 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	6 Participants	8 Participants	8 Participants	7 Participants	29 Participants
Sex: Female, Male Female	6 Participants	5 Participants	5 Participants	2 Participants	18 Participants
Sex: Female, Male Male	4 Participants	5 Participants	5 Participants	8 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 10	0 / 10	0 / 10
other Total, other adverse events	9 / 10	10 / 10	10 / 10	8 / 10
serious Total, serious adverse events	0 / 10	0 / 10	0 / 10	0 / 10

Outcome results

Primary

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.

Time frame: 7 days after product administration

Population: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=40).

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Mild	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	9 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	1 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	None	10 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	9 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	10 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	1 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	1 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	9 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	10 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	0 Participants
Group 1	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	10 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	10 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	1 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	None	10 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	9 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Mild	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	9 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	10 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	1 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	0 Participants
Group 2	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	9 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	9 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	8 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	9 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	None	10 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Mild	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Moderate	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Severe	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	0 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	8 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	1 Participants
Group 3	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	1 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Mild	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	None	10 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	Mild	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Swelling	None	10 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	None	4 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Mild	1 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Local Symptom	Mild	6 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pruritus	None	9 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	Mild	6 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	None	9 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Severe	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Redness	Moderate	0 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Pain/Tenderness	None	4 Participants
Group 4	Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Axillary Lymphadenopathy Ipsilateral	Mild	1 Participants

Primary

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.

Time frame: 7 days after product administration

Population: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=40)

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	1 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	6 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	4 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	9 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	8 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	6 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	4 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	9 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	1 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	8 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	9 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	2 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	2 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	10 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	1 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 1	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	4 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	6 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	3 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	1 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	9 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	10 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	1 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	6 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	9 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	8 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	1 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	4 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	2 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	4 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	6 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	5 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	1 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	0 Participants
Group 2	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	1 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	4 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	1 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	4 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	7 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	2 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	8 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	6 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	1 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	2 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	2 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	5 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	6 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	1 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	8 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	1 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	1 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	4 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	3 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	1 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 3	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	6 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	None	8 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Mild	2 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Moderate	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Malaise	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	None	8 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Mild	2 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Moderate	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Myalgia	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	None	9 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Mild	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Moderate	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Headache	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	None	9 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Mild	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Moderate	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Chills	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	None	9 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Mild	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Moderate	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Nausea	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	None	10 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Mild	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Moderate	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Temperature	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	None	9 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Mild	1 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Moderate	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Joint Pain	Severe	0 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	None	7 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Mild	2 Participants
Group 4	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration	Any Systemic Symptom	Moderate	1 Participants

Primary

Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration

Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized\*. Safety lab parameters included pregnancy test, hematology and chemistry labs, and HIV Serology diagnostic test. Institutional lab normal ranges as well as Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.

Time frame: Day 0 after product administration through Day 392, up to Week 56

Population: \*Abnormal Laboratory Measures of Safety Following Product Administration. Participants are counted once for each category at the highest severity of AE regardless of the number of events or attribution to study vaccine.

Arm	Measure	Group	Value (NUMBER)
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Total	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Severe	0 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Total	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Total	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Severe	0 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Mild	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Mild	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Moderate	0 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Total	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Mild	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Severe	0 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Mild	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Severe	0 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Moderate	0 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Moderate	0 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Total	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Mild	1 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Moderate	0 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Moderate	0 participants
Group 1	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Severe	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Moderate	1 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Severe	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Moderate	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Severe	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Mild	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Total	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Moderate	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Mild	2 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Moderate	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Mild	1 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Severe	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Moderate	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Severe	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Severe	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Mild	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Total	3 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Total	1 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Total	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Total	0 participants
Group 2	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Mild	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Mild	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Mild	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Moderate	1 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Severe	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Total	1 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Moderate	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Severe	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Total	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Mild	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Moderate	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Severe	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Total	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Mild	2 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Moderate	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Severe	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Total	2 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Mild	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Moderate	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Severe	0 participants
Group 3	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Total	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Moderate	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Mild	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Severe	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Total	2 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Total	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Severe	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Moderate	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Mild	1 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Moderate	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ELEVATED AST : Mild	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Mild	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Moderate	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Total	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Mild	1 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	ANEMIA : Severe	0 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Moderate	1 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Total	1 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	HYPERBILIRUBINEMIA : Severe	1 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	NEUTROPENIA : Total	1 participants
Group 4	Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration	LEUKOPENIA : Severe	0 participants

Primary

Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration

An AESI is an AE (serious or nonserious) of scientific medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor is required.

Time frame: Day 0 after product administration through Day 392, up to Week 56

Population: Population included all enrolled participants who received study product (N=40)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration	Anaphylaxis	0 Participants
Group 1	Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration	Myocarditis and Pericarditis	0 Participants
Group 2	Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration	Myocarditis and Pericarditis	0 Participants
Group 2	Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration	Anaphylaxis	0 Participants
Group 3	Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration	Anaphylaxis	0 Participants
Group 3	Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration	Myocarditis and Pericarditis	0 Participants
Group 4	Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration	Anaphylaxis	0 Participants
Group 4	Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration	Myocarditis and Pericarditis	0 Participants

Primary

Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration

MAAEs are defined as adverse events leading to hospitalization, an emergency room visit or an otherwise unscheduled visit to or from medical personnel, for any reason.

Time frame: First vaccination to 6 months

Population: Population included all enrolled participants who received study product (N=40)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	PARONYCHIA	0 Participants
Group 1	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	WHIPLASH	0 Participants
Group 1	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	UPPER RESPIRATORY INFECTION	0 Participants
Group 1	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	MUSCLE STRAIN	0 Participants
Group 1	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	VERTEBRAL DISC HERNIATION	1 Participants
Group 1	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	URTICARIA	0 Participants
Group 1	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	LIGAMENT TEAR	0 Participants
Group 2	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	VERTEBRAL DISC HERNIATION	0 Participants
Group 2	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	WHIPLASH	0 Participants
Group 2	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	URTICARIA	0 Participants
Group 2	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	MUSCLE STRAIN	1 Participants
Group 2	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	LIGAMENT TEAR	0 Participants
Group 2	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	UPPER RESPIRATORY INFECTION	1 Participants
Group 2	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	PARONYCHIA	0 Participants
Group 3	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	WHIPLASH	1 Participants
Group 3	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	VERTEBRAL DISC HERNIATION	0 Participants
Group 3	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	MUSCLE STRAIN	0 Participants
Group 3	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	UPPER RESPIRATORY INFECTION	0 Participants
Group 3	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	LIGAMENT TEAR	1 Participants
Group 3	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	URTICARIA	1 Participants
Group 3	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	PARONYCHIA	1 Participants
Group 4	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	LIGAMENT TEAR	0 Participants
Group 4	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	UPPER RESPIRATORY INFECTION	0 Participants
Group 4	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	WHIPLASH	0 Participants
Group 4	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	PARONYCHIA	0 Participants
Group 4	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	MUSCLE STRAIN	0 Participants
Group 4	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	VERTEBRAL DISC HERNIATION	0 Participants
Group 4	Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration	URTICARIA	0 Participants

Primary

Number of Participants With New Chronic Medical Conditions Following Product Administration

New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit through Day 392, up to Week 56. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity

Time frame: Day 0 after product administration through Day 392, up to Week 56

Population: Population included all enrolled participants who received study product (N=40)

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants
Group 1	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 1	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants
Group 1	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	10 Participants
Group 2	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 2	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants
Group 2	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	10 Participants
Group 2	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants
Group 3	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants
Group 3	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 3	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	10 Participants
Group 3	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants
Group 4	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With No New Chronic Medical Condition	10 Participants
Group 4	Number of Participants With New Chronic Medical Conditions Following Product Administration	Unrelated to Study Product	0 Participants
Group 4	Number of Participants With New Chronic Medical Conditions Following Product Administration	Related to Study Product	0 Participants
Group 4	Number of Participants With New Chronic Medical Conditions Following Product Administration	Number of Participants With New Chronic Medical Condition	0 Participants

Primary

Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration

Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Time frame: Day 0 through 28 days post product administration, up to Week 4

Population: Population included all enrolled participants who received study product (N=40).

Arm	Measure	Group	Value (NUMBER)
Group 1	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	0 participants
Group 1	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	5 participants
Group 1	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	5 participants
Group 2	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	1 participants
Group 2	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	5 participants
Group 2	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	5 participants
Group 3	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	7 participants
Group 3	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	5 participants
Group 3	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	7 participants
Group 4	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Related to Study Product	3 participants
Group 4	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Total Number of Participants who had One or More Non-Serious Unsolicited AE	8 participants
Group 4	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration	Unrelated to Study Product	7 participants

Primary

Number of Participants With Serious Adverse Events Following Product Administration

SAEs were recorded from receipt of product administration through the last study visit at Week 56. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

Time frame: Day 0 after product administration through Day 392, up to Week 56

Population: Population included all enrolled participants who received study product (N=40).

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 1	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 1	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants
Group 1	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	10 Participants
Group 2	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 2	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants
Group 2	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	10 Participants
Group 2	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 3	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants
Group 3	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 3	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	10 Participants
Group 3	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 4	Number of Participants With Serious Adverse Events Following Product Administration	Total number of Participants who did not have SAE	10 Participants
Group 4	Number of Participants With Serious Adverse Events Following Product Administration	Unrelated to Study Product	0 Participants
Group 4	Number of Participants With Serious Adverse Events Following Product Administration	Related to Study Product	0 Participants
Group 4	Number of Participants With Serious Adverse Events Following Product Administration	Total Number of Participants who had SAE	0 Participants

Secondary

Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).

Vaccine-induced binding antibody titers against G antigen of Nipah virus Malaysia strain (NiV(M)) were measured by ELISA. The value of the antibody response was determined by obtaining half of the maximum effective concentration (EC50) titer from the optical density 450 nm curves for the function of the reciprocal dilution using a four-parameter logistic curve fit in Prism (version 10.2.2). NiV G EC50 titers were normalized using the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) international standard (IS, NIBSC code 22/130) and are reported as group geometric mean titers (GMTs) and 95% confidence intervals (CIs) in international units per milliliter (IU/ml).

Time frame: Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).

Population: Baseline analyses included all study participants who received the first dose (N=40) and Week 6 analyses included all study participants who received both the first and the second doses (N=38). One participant in 10 mcg dose group received only one vaccination and one participant in 25 mcg dose group missed Week 6 visit.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1	Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 0	12.48 IU/mL
Group 1	Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 6	4626.43 IU/mL
Group 2	Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 0	2.84 IU/mL
Group 2	Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 6	5013 IU/mL
Group 3	Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 6	4279.39 IU/mL
Group 3	Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 0	4.12 IU/mL
Group 4	Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 6	2403.1 IU/mL
Group 4	Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 0	6.91 IU/mL

Secondary

Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).

Vaccine-induced binding antibody titers against Pre-F antigen of Nipah virus Malaysia strain (NiV(M)) were measured by ELISA. The value of the antibody response was determined by obtaining half of the maximum effective concentration (EC50) titer from the optical density 450 nm curves for the function of the reciprocal dilution using a four-parameter logistic curve fit in Prism (version 10.2.2). NiV Pre-F EC50 titers were normalized using the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC) international standard (IS, NIBSC code 22/130) and are reported as group geometric mean titers (GMTs) and 95% confidence intervals (CIs) in international units per milliliter (IU/ml).

Time frame: Serum samples collected at baseline (Week 0) and at two weeks after the second product administration (Week 6).

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Group 1	Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 0	4.44 IU/mL
Group 1	Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 6	1941.62 IU/mL
Group 2	Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 6	1885.99 IU/mL
Group 2	Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 0	1.28 IU/mL
Group 3	Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 0	1.83 IU/mL
Group 3	Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 6	1411.64 IU/mL
Group 4	Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 0	3.03 IU/mL
Group 4	Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).	Week 6	923.47 IU/mL

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026

Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults

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Outcome results

Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration

Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration

Number of Participants With Adverse Events of Special Interest (AESI) Following Product Administration

Number of Participants With Medically Attended Adverse Events (MAAEs) Following Product Administration

Number of Participants With New Chronic Medical Conditions Following Product Administration

Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration

Number of Participants With Serious Adverse Events Following Product Administration

Geometric Mean NiV(M) G Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).

Geometric Mean NiV(M) Pre-F Binding Antibody Titer (GMTs) and 95% Confidence Intervals (CIs).