Study of a Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (VAD00001)

Study of a Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (VAD00001)

Brief Summary:
The primary objectives of the study are:
- To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline neutralizing antibody serostatus.
- To characterize the RSV-A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in Respiratory Syncytial Virus (RSV) seronegative participants.

The secondary objectives of the study are:
- To quantify the amount of vaccine virus shed by each participant by baseline neutralizing antibody serostatus.
- To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus after vaccination by baseline neutralizing antibody serostatus.
- To characterize the RSV-A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV seropositive participants.
- To characterize serum RSV-A anti-F immunoglobulin G antibody responses to the study product in each vaccine group after vaccination by baseline neutralizing antibody serostatus.
- To characterize serum RSV-A antibody responses (neutralizing and anti-F immunoglobulin G) to the study product in each vaccine group after the RSV season by baseline neutralizing antibody serostatus.

Detailed Description:
Study duration per participant is maximum 12 months


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety, Immunogenicity, Infectivity, and Dose-Finding Study of an Investigational Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Infants and Toddlers
Actual Study Start Date: September 17, 2020
Estimated Primary Completion Date: April 28, 2023
Estimated Study Completion Date: April 28, 2023

Arm:
- Experimental: Cohort 1 (RSV vaccine formulation 1)
- Placebo Comparator: Cohort 1 (Placebo)
- Experimental: Cohort 2 (RSV vaccine formulation 1)
- Placebo Comparator: Cohort 2 (Placebo)
- Experimental: Cohort 3 (RSV vaccine formulation 2)
- Placebo Comparator: Cohort 3 (Placebo)
- Experimental: Cohort 4 (RSV vaccine formulation 1)
- Experimental: Cohort 4 (RSV vaccine formulation 2)
- Placebo Comparator: Cohort 4 (Placebo)

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