Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Phase Ib Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, Lot RSV#010A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04520659

Enrollment

Registered

2020-08-20

Start date

2022-03-16

Completion date

2024-04-18

Last updated

2026-07-20

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

Conditions

RSV Infection

Brief summary

The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine, LID/ΔM2-2/1030s, in RSV-seronegative infants and children 6 to 24 months of age.

Detailed description

This study will evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine, LID/ΔM2-2/1030s, in RSV-seronegative infants and children 6 to 24 months of age. Participants will be randomly assigned to one of two groups to receive a single dose of intranasal RSV LID/ΔM2-2/1030s vaccine or placebo at study entry (Day 0). Group 1 (intensive) and Group 2 (less intensive) will differ only in the frequency of study visits and nasal swab collections. Participants will receive study product between April 1 and October 15, outside of the RSV season, and will remain on the study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Participants' total study duration is between 6 and 13 months, depending upon time of enrollment. Participants will attend several study visits throughout the study, which may include blood collection, nasal swabs, and physical examinations. Some of these visits may be remote if a stay at home order is put in place after enrollment.

Interventions

BIOLOGICALRSV LID/ΔM2-2/1030s

10\^5 plaque-forming units (PFU); administered as nose drops

BIOLOGICALPlacebo

Administered as nose drops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 24 Months

Healthy volunteers

Yes

Inclusion criteria

* ≥ 6 months of age and \<25 months of age at the time of inoculation * Screening and pre-inoculation serum specimens for respiratory syncytial virus (RSV)-neutralizing antibody are obtained no more than 42 days prior to inoculation * Seronegative for RSV antibody, defined as serum RSV-neutralizing antibody titer \<1:40 * In good health based on review of the medical record, history, and physical examination at the time of inoculation * Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger * Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND * If \< 1 year of age: has a current height and weight above the 5th percentile for age * If ≥ 1 year of age: has a current height and weight above the 3rd percentile for age * Expected to be available for the duration of the study * Parent/guardian is willing and able to provide written informed consent

Exclusion criteria

* ≤ 6 months of age and \> 25 months of age at the time of inoculation * Born at less than 34 weeks gestation * Born at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age * Maternal history of a positive HIV test before or during pregnancy * Evidence of chronic disease * Known or suspected infection or impairment of immunological functions * Bone marrow/solid organ transplant recipient * Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities * Suspected or documented developmental disorder, delay, or other developmental problem * Cardiac abnormality requiring treatment * Lung disease or reactive airway disease * More than one episode of medically diagnosed wheezing in the first year of life * Wheezing episode or received bronchodilator therapy within the past 12 months * Wheezing episode or received bronchodilator therapy after the age of 12 months * Previous receipt of supplemental oxygen therapy in a home setting * Previous receipt of an investigational RSV vaccine * Previous receipt or planned administration of anti-RSV antibody product including ribavirin, RSV Ig, or RSV mAb * Previous receipt of immunoglobulin or any antibody products within the past 6 months * Previous receipt of any blood products within the past 6 months * Previous anaphylactic reaction * Previous vaccine-associated adverse reaction that was Grade 3 or above * Known hypersensitivity to any study product component * Member of a household that contains an infant who is less than 6 months of age at the date of inoculation through the 28th day after inoculation * Member of a household that, at the date of inoculation through the 28th day after inoculation, contains an immunocompromised individual including but not limited to: * a person who is HIV-infected * a person who has cancer and has received chemotherapy within the 12 months prior to enrollment * a person living with a solid organ or bone marrow transplant * Attends a daycare facility that does not separate children by age and contains an infant \<6 months of age at the date of inoculation through the 28th day after inoculation * Receipt of any of the following prior to enrollment: * inactivated influenza vaccine within 3 days prior, or * any other inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or * any live vaccine, other than rotavirus vaccine, within the 28 days prior, or * another investigational vaccine or investigational drug within 28 days prior, or * salicylate (aspirin) or salicylate-containing products within the past 28 days * Scheduled administration of any of the following after planned inoculation * inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or * any live vaccine other than rotavirus in the 28 days after, or * another investigational vaccine or investigational drug in the 56 days after * Receipt of any of the following medications within 3 days of study enrollment: * systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or * intranasal medications, or * other prescription medications except the permitted concomitant medications listed below * Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents. * Any of the following events at the time of enrollment: * fever (temporal or rectal temperature of ≥100.4°F), or * upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or * nasal congestion significant enough to interfere with successful inoculation, or * otitis media * contact with a person diagnosed with COVID-19 disease or active severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) infection within the preceding 10 days

Design outcomes

Primary

Measure	Time frame	Description
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Measured through Day 28	Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix III of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document. Details regarding LRIs will be noted in Primary Outcome Measure #2.
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Measured through Day 28	LRI may include wheezing, pneumonia, laryngotracheobronchitis (croup), rhonchi and rales as defined in Appendix III of the protocol document. A participant was only counted once in each LRI category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document.
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Measured through Day 28	Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented.
Number of Participants Who Experienced Serious Adverse Events (SAEs)	Measured Day 0 through Day 56 after inoculation and During the RSV Surveillance Season (Date of seasonal pause in enrollment in year of inoculation through March 31)	A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that: Results in death during the period of protocol-defined surveillance; Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe; Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting; Results in a persistent or significant disability/incapacity; Is a congenital anomaly or birth defect, OR Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer	Measured at Day 0 and Day 56	Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.
Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RT-qPCR) (Group 1 Only)	Measured at Days 5, 7, 10, 12 and additional illness visits between Days 0 and 28.	This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by RT-qPCR. Group 1 participants only. Only participants who met the definition of infection with vaccine virus were included.
Number of Vaccinees Infected With RSV Vaccine Virus in Group 1	Measured through Day 56	Defined as shedding vaccine virus, detected by RT-qPCR, and/or ≥4-fold rise in RSV-specific serum antibodies, detected by enzyme-linked immunosorbent assay (ELISA) against the RSV F protein and/or an RSV-PRNT from study entry to Study Day 56

Secondary

Measure	Time frame	Description
Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31)	The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal swabs collected during illness visits for MAARI events or a \> 2.5-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document.
Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31)	The number of participants who had RSV-associated, symptomatic, medically attended acute lower respiratory illness (MAALRI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal swabs collected during illness visits for MAALRI events or a ≥ 2.5-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each LRI category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document.
Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG	Measured at Day 0 and Day 56	Serum RSV preF IgG titers and RSV postF IgG titers were assessed by an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a ≥4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRuth A. Karron, MD

Johns Hopkins Bloomberg School of Public Health (JHSPH)

Participant flow

Recruitment details

Participants were recruited from pediatric practices and clinics in the greater Baltimore, MD/Washington, DC, Rochester, NY and Nashville, TN areas based on referral by the primary care provider or the provider's staff; and through electronic patient portals using IRB-approved messages. These recruitment methods targeted age-appropriate children between February, 2022 and March, 2023. The first participant was enrolled on 3/16/22 and the last participant was enrolled on 5/10/23.

Pre-assignment details

Of the 111 participants that were screened, 81 met eligibility criteria and the parent agreed to enroll their child. The 81 children were then inoculated with study product.

Participants by arm

Arm	Count
Group 1: RSV LID/ΔM2-2/1030s Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops	14
Group 1: Placebo Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops	7
Group 2: RSV LID/ΔM2-2/1030s Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0). RSV LID/ΔM2-2/1030s: 10\^5 plaque-forming units (PFU); administered as nose drops	40
Group 2: Placebo Participants will receive a single dose of placebo at study entry (Day 0). Placebo: Administered as nose drops	20
Total	81

Baseline characteristics

Characteristic	Total	Group 2: Placebo	Group 2: RSV LID/ΔM2-2/1030s	Group 1: Placebo	Group 1: RSV LID/ΔM2-2/1030s
Age, Customized 13-18 months of age	24 Participants	9 Participants	10 Participants	2 Participants	3 Participants
Age, Customized 19-24 months of age	15 Participants	3 Participants	5 Participants	4 Participants	3 Participants
Age, Customized > 24 months of age	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized 6-12 months of age	42 Participants	8 Participants	25 Participants	1 Participants	8 Participants
Age, Customized < 6 months of age	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants	2 Participants	6 Participants	0 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants	18 Participants	33 Participants	7 Participants	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants	0 Participants	0 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	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	3 Participants	1 Participants	1 Participants	0 Participants	1 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	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	73 Participants	18 Participants	37 Participants	7 Participants	11 Participants
Region of Enrollment United States	81 participants	20 participants	40 participants	7 participants	14 participants
Sex: Female, Male Female	41 Participants	9 Participants	19 Participants	3 Participants	10 Participants
Sex: Female, Male Male	40 Participants	11 Participants	21 Participants	4 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 14	0 / 7	0 / 39	0 / 18	0 / 53	0 / 25
other Total, other adverse events	11 / 14	7 / 7	31 / 39	13 / 18	42 / 53	20 / 25
serious Total, serious adverse events	1 / 14	0 / 7	0 / 39	0 / 18	1 / 53	0 / 25

Outcome results

Primary

Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade

Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI) as defined in Appendix III of the protocol document. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document. Details regarding LRIs will be noted in Primary Outcome Measure #2.

Time frame: Measured through Day 28

Population: Study participants who received inoculation and were followed on study past Day 0 were included.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 2	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 1	9 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 1	2 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Did not have this AE	11 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Did not have this AE	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 2	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Did not have this AE	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Did not have this AE	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Did not have this AE	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Did not have this AE	4 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Did not have this AE	7 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Did not have this AE	7 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Did not have this AE	7 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Did not have this AE	7 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Did not have this AE	6 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 1	3 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 2	1 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Did not have this AE	4 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Did not have this AE	37 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 2	2 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 2	4 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 1	8 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Did not have this AE	40 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 2	3 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 2	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 2	3 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Did not have this AE	27 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Did not have this AE	29 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 3	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 1	24 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Did not have this AE	39 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 1	9 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Did not have this AE	13 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 2	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 2	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Did not have this AE	20 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 1	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 2	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Did not have this AE	16 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 1	3 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 2	1 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Did not have this AE	18 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 1	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 2	2 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Did not have this AE	11 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 1	4 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 2	1 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 3	3 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 4	1 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Did not have this AE	12 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 1	7 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 2	1 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Did not have this AE	20 Participants
Group 2: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 2	4 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Did not have this AE	51 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Did not have this AE	53 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 3	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 2	3 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Did not have this AE	17 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 1	11 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Did not have this AE	40 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 1	33 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 2	4 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 2	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Did not have this AE	54 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Did not have this AE	41 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 1	8 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 2	3 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 2	1 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Did not have this AE	25 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 2	1 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 3	3 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Did not have this AE	27 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 1	4 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Grade 4	1 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 2	2 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Grade 1	3 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Lower Respiratory Illness (LRI) with RSV shedding	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Did not have this AE	16 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Cough without LRI	Did not have this AE	22 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Otitis media	Grade 2	2 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Did not have this AE	27 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Fever	Did not have this AE	18 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	Upper Respiratory	Grade 1	10 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade	LRI in the absence of RSV shedding	Grade 4	0 Participants

Primary

Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade

LRI may include wheezing, pneumonia, laryngotracheobronchitis (croup), rhonchi and rales as defined in Appendix III of the protocol document. A participant was only counted once in each LRI category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document.

Time frame: Measured through Day 28

Population: Study participants who received inoculation and were followed on study past Day 0 were included.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Did not have this LRI	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Did not have this LRI	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Did not have this LRI	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Did not have this LRI	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Did not have this LRI	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Did not have this LRI	7 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Did not have this LRI	7 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Did not have this LRI	7 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 1	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Did not have this LRI	7 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 2	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Did not have this LRI	7 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Group 1: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Did not have this LRI	40 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Did not have this LRI	40 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Did not have this LRI	39 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 2	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Did not have this LRI	40 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Did not have this LRI	40 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 2	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 2	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Did not have this LRI	20 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 1	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 1	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Did not have this LRI	20 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 2	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 3	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Did not have this LRI	20 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Did not have this LRI	20 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 1	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 2	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 2	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Did not have this LRI	20 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 4	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Group 2: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Did not have this LRI	54 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Did not have this LRI	54 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Did not have this LRI	53 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Did not have this LRI	54 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 2	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Did not have this LRI	54 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Did not have this LRI	27 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rhonchi	Did not have this LRI	27 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Wheezing	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Laryngotracheobronchitis (Croup)	Did not have this LRI	27 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Pneumonia	Did not have this LRI	27 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade	Rales	Did not have this LRI	27 Participants

Primary

Number of Participants Who Experienced Serious Adverse Events (SAEs)

A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that: Results in death during the period of protocol-defined surveillance; Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe; Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting; Results in a persistent or significant disability/incapacity; Is a congenital anomaly or birth defect, OR Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.

Time frame: Measured Day 0 through Day 56 after inoculation and During the RSV Surveillance Season (Date of seasonal pause in enrollment in year of inoculation through March 31)

Population: Study participants who received inoculation and were followed on study past Day 0 were included.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants Who Experienced Serious Adverse Events (SAEs)	1 Participants
Group 1: Placebo	Number of Participants Who Experienced Serious Adverse Events (SAEs)	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants Who Experienced Serious Adverse Events (SAEs)	0 Participants
Group 2: Placebo	Number of Participants Who Experienced Serious Adverse Events (SAEs)	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants Who Experienced Serious Adverse Events (SAEs)	1 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants Who Experienced Serious Adverse Events (SAEs)	0 Participants

Primary

Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity

Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced unsolicited adverse events was presented.

Time frame: Measured through Day 28

Population: Study participants who received inoculation and were followed on study past Day 0 were included.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 1	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Did not have this	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 2	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Did not have this	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Did not have this	13 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Did not have this	14 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Did not have this	12 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 1	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 2	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Did not have this	12 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 1	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 2	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Did not have this	13 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Did not have this	7 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 3	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 3	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 3	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 4	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 2	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Did not have this	6 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 1	1 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 2	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 4	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 4	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Did not have this	7 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 1	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 1	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 1	1 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 2	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Did not have this	7 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 3	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 4	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 4	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Did not have this	6 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 3	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 1	1 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 2	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 2	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 2	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 3	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 1	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 4	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Did not have this	6 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Did not have this	7 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 3	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 1	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 4	0 Participants
Group 1: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Did not have this	37 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 1	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 2	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Did not have this	39 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Did not have this	29 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 1	11 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Did not have this	37 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Did not have this	40 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Did not have this	39 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Did not have this	40 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 1	3 Participants
Group 2: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 1	3 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Did not have this	20 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Did not have this	18 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 1	2 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 2	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 3	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 4	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Did not have this	20 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 1	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 2	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 3	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 4	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Did not have this	19 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 1	1 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 2	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 3	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 4	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Did not have this	19 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 1	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 2	1 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 3	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 4	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Did not have this	19 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 1	1 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 2	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 3	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 4	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Did not have this	19 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 1	1 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 2	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 3	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 4	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 1	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 2	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 3	0 Participants
Group 2: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 1	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 1	2 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 2	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Did not have this	52 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 1	4 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Did not have this	53 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 2	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Did not have this	49 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 1	3 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Did not have this	43 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 2	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Did not have this	52 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Did not have this	54 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Did not have this	50 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 1	11 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 2	1 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 2	1 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Did not have this	26 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 1	3 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Did not have this	26 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 1	1 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Grade 1	2 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Diarrhea	Did not have this	25 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Did not have this	24 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Rash	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Did not have this	27 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Emesis	Did not have this	27 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Did not have this	25 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Urinary tract infection	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 1	2 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Conjunctivitis	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Nasal Congestion	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity	Pain	Grade 2	0 Participants

Primary

Number of Vaccinees Infected With RSV Vaccine Virus in Group 1

Defined as shedding vaccine virus, detected by RT-qPCR, and/or ≥4-fold rise in RSV-specific serum antibodies, detected by enzyme-linked immunosorbent assay (ELISA) against the RSV F protein and/or an RSV-PRNT from study entry to Study Day 56

Time frame: Measured through Day 56

Population: Study participants in Group 1 who received RSV LID/ΔM2-2/1030s at inoculation and were followed on study past Day 56 were included.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Group 1: RSV LID/ΔM2-2/1030s	Number of Vaccinees Infected With RSV Vaccine Virus in Group 1	14 Participants

Primary

Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RT-qPCR) (Group 1 Only)

This is the mean of the highest value per participant of the titer of vaccine virus shed. It was measured by RT-qPCR. Group 1 participants only. Only participants who met the definition of infection with vaccine virus were included.

Time frame: Measured at Days 5, 7, 10, 12 and additional illness visits between Days 0 and 28.

Population: Only participants who met the definition of infection with vaccine virus were included.

Arm	Measure	Value (MEAN)	Dispersion
Group 1: RSV LID/ΔM2-2/1030s	Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RT-qPCR) (Group 1 Only)	6.6 log 10 copies/mL	Standard Deviation 1.3

Primary

Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer

Serum RSV-neutralizing antibody titers were assessed by 60% RSV-plaque reduction neutralization titer (RSV-PRNT) assay. Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.

Time frame: Measured at Day 0 and Day 56

Population: Study participants who received RSV LID/ΔM2-2/1030s at inoculation and were followed on study past Day 56 were included. One study participant in Group 2 withdrew prior to the Day 56 serum collection and is not included in this analysis.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Group 1: RSV LID/ΔM2-2/1030s	Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer	12 Participants
Group 1: Placebo	Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer	26 Participants
Group 2: RSV LID/ΔM2-2/1030s	Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer	38 Participants

Secondary

Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season

The number of participants who had RSV-associated, symptomatic, medically attended acute lower respiratory illness (MAALRI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal swabs collected during illness visits for MAALRI events or a ≥ 2.5-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each LRI category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document.

Time frame: Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31)

Population: Only participants who had RSV detected in nasal swabs or had \> 4 fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events were included. Two vaccinees were excluded due to withdrawing prior to the completing the RSV surveillance period, and one placebo recipient was excluded due to parent refused to allow collection of the post-surveillance serum sample.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Did not have this MAALRI	12 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 2	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Did not have this MAALRI	13 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Did not have this MAALRI	12 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Did not have this MAALRI	13 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 3	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Did not have this MAALRI	11 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 2	2 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Did not have this MAALRI	12 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 2	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Did not have this MAALRI	13 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Did not have this MAALRI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Did not have this MAALRI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Did not have this MAALRI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Did not have this MAALRI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Did not have this MAALRI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Did not have this MAALRI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Did not have this MAALRI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 2	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Did not have this MAALRI	26 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 2	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 2	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Did not have this MAALRI	26 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 2	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Did not have this MAALRI	26 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Did not have this MAALRI	27 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Did not have this MAALRI	27 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 2	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Did not have this MAALRI	27 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Did not have this MAALRI	26 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Did not have this MAALRI	10 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Did not have this MAALRI	11 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 2	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Did not have this MAALRI	11 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 2	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Did not have this MAALRI	11 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 2	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Did not have this MAALRI	11 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 2	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Did not have this MAALRI	11 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 2	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Did not have this MAALRI	11 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 2	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 2	1 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 2	2 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Did not have this MAALRI	37 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Did not have this MAALRI	40 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 2	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 2	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Did not have this MAALRI	38 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Did not have this MAALRI	38 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 2	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 3	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Did not have this MAALRI	39 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Did not have this MAALRI	40 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Did not have this MAALRI	39 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 2	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 2	3 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Did not have this MAALRI	16 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Did not have this MAALRI	16 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchitis	Did not have this MAALRI	16 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Did not have this MAALRI	16 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rales	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Did not have this MAALRI	15 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Pneumonia	Did not have this MAALRI	16 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Did not have this MAALRI	16 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Bronchiolitis	Grade 2	1 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	laryngotracheobronchitis (Croup)	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Wheezing	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Rhonchi	Grade 2	0 Participants

Secondary

Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season

The number of participants who had RSV-associated, symptomatic, medically attended respiratory and febrile illness (MAARI) among those who had indicators of natural infection with wt RSV were presented. Natural infection with wt RSV during the RSV season surveillance was defined as having either RSV detected in nasal swabs collected during illness visits for MAARI events or a \> 2.5-fold rise in serum antibodies from pre- to post-RSV season in the absence of RSV-associated medical events. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 16 and Table 17 in the protocol document.

Time frame: Measured during RSV season (from date of seasonal pause in enrollment in the year of inoculation through March 31)

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Did not have this MAARI	11 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 2	5 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 3	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 2	1 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 2	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 3	5 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Did not have this MAARI	8 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Did not have this MAARI	6 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 2	5 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Did not have this MAARI	8 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 2	7 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Did not have this MAARI	8 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 2	2 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 4	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 3	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 1	0 Participants
Group 1: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Did not have this MAARI	11 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Did not have this MAARI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Did not have this MAARI	2 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 1	1 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Did not have this MAARI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 2	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Did not have this MAARI	5 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 1	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 3	1 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Did not have this MAARI	2 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Did not have this MAARI	4 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 4	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 3	0 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 2	3 Participants
Group 1: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 2	2 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 2	15 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Did not have this MAARI	15 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 1	3 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 2	3 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 3	6 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Did not have this MAARI	12 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Did not have this MAARI	26 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 2	1 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Did not have this MAARI	25 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 2	2 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Did not have this MAARI	12 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 2	15 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 4	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Did not have this MAARI	16 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 1	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 2	11 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 3	0 Participants
Group 2: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 2	3 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 1	2 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Did not have this MAARI	10 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Did not have this MAARI	5 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 3	1 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 1	1 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Did not have this MAARI	4 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 2	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 2	5 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 2	1 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 1	1 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 3	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Did not have this MAARI	11 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 2	5 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 2	2 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Did not have this MAARI	8 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 4	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 1	0 Participants
Group 2: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Did not have this MAARI	7 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Did not have this MAARI	23 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Did not have this MAARI	36 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 2	16 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 2	4 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 2	22 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Did not have this MAARI	20 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Did not have this MAARI	18 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 2	20 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 3	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 3	11 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 4	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Did not have this MAARI	24 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 2	3 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 1	0 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 2	2 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 1	3 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 3	1 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Did not have this MAARI	37 Participants
Groups 1 and 2 Combined: RSV LID/ΔM2-2/1030s	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Did not have this MAARI	7 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 2	2 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Did not have this MAARI	11 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 2	3 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Did not have this MAARI	13 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Did not have this MAARI	16 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 1	2 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 1	1 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 2	8 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 1	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 2	7 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Grade 2	1 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Otitis media	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 1	2 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	LRI in the absence of RSV	Grade 2	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Fever	Grade 3	2 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Lower Respiratory Illness with RSV	Did not have this MAARI	15 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 4	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Did not have this MAARI	6 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Upper Respiratory Illness	Grade 3	0 Participants
Groups 1 and 2 Combined: Placebo	Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season	Cough without LRI	Grade 4	0 Participants

Secondary

Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG

Serum RSV preF IgG titers and RSV postF IgG titers were assessed by an Enzyme-linked Immunosorbent Assay (ELISA). Antibody responses were defined as a ≥4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.

Time frame: Measured at Day 0 and Day 56

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Group 1: RSV LID/ΔM2-2/1030s	Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG	RSV PreF IgG	9 Participants
Group 1: RSV LID/ΔM2-2/1030s	Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG	RSV PostF IgG	12 Participants
Group 1: Placebo	Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG	RSV PreF IgG	22 Participants
Group 1: Placebo	Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG	RSV PostF IgG	28 Participants
Group 2: RSV LID/ΔM2-2/1030s	Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG	RSV PreF IgG	31 Participants
Group 2: RSV LID/ΔM2-2/1030s	Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG	RSV PostF IgG	40 Participants

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Contacts

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade

Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade

Number of Participants Who Experienced Serious Adverse Events (SAEs)

Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity

Number of Vaccinees Infected With RSV Vaccine Virus in Group 1

Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RT-qPCR) (Group 1 Only)

Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer

Frequency of RSV-medically Attended Acute Lower Respiratory Illness (MAALRI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season

Frequency of RSV-medically Attended Acute Respiratory Illness (MAARI) by Grade in Vaccine and Placebo Recipients Who Experience Natural Infection With Wild Type RSV During the Subsequent RSV Season

Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV preF IgG and/or RSV postF IgG