CompletedPhase 1

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

United States60 participantsStarted 2018-06-29

Plain-language summary

The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.

Who can participate

Age range

6 Months – 59 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION CRITERIA FOR RSV-SEROPOSITIVE CHILDREN * Greater than or equal to 12 months of age and less than 60 months of age at the time of inoculation * Screening serum specimen for RSV-neutralizing antibody is obtained within the calendar year of inoculation * Seropositive for RSV antibody, defined as serum RSV-neutralizing antibody titer greater than or equal to 1:40 * Pre-inoculation serum sample for RSV-neutralizing antibody specimen is obtained no more than 56 days prior to inoculation * In good health based on review of the medical record, history, and physical examination (PE) 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 standard growth chart and 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 FOR RSV-SEROPOSITIVE CHILDREN * Born at less than 34 weeks gestation * Maternal history of positive human immunodeficiency virus (HIV) test * Evidence of chronic disease * Known or suspected impairment of immune function * Bone marrow/solid organ transplant recipient * Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities * Suspected or docu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)

Timeframe: Measured through Day 10

Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)

Timeframe: Measured through Day 28

Number of Participants With Unsolicited AEs (RSV-seropositive Participants)

Timeframe: Measured through Day 10

Number of Participants With Unsolicited AEs (RSV-seronegative Participants)

Timeframe: Measured through Day 28

Number of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants)

Timeframe: Measured through Day 28

Number of Participants With Serious Adverse Events (SAEs) (RSV-seronegative Participants)

Timeframe: Measured through Day 56

Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Participants)

Trial details

NCT IDNCT03596801

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-04-25

Results submitted2025-12-08

View on ClinicalTrials.gov More RSV Infection trials

Plain-language summary

Who can participate

Age range

6 Months – 59 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants)

Timeframe: Measured through Day 10

Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seronegative Participants)

Timeframe: Measured through Day 28

Number of Participants With Unsolicited AEs (RSV-seropositive Participants)

Timeframe: Measured through Day 10

Number of Participants With Unsolicited AEs (RSV-seronegative Participants)

Timeframe: Measured through Day 28

Number of Participants With Serious Adverse Events (SAEs) (RSV-seropositive Participants)

Timeframe: Measured through Day 28

Number of Participants With Serious Adverse Events (SAEs) (RSV-seronegative Participants)

Timeframe: Measured through Day 56

Frequency of Infection With RSV Vaccine Virus (RSV-seropositive Participants)