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

STATUS

Recruiting
End date

Apr 27, 2023
participants needed

300
sponsor

Sanofi Pasteur, a Sanofi Company

Send

Updated on 26 May 2022

See if I qualify

vaccination

respiratory syncytial virus vaccines

Accepts healthy volunteers

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 Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in 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 anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline neutralizing antibody serostatus.
To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline neutralizing antibody serostatus.

Description

Study duration per participant is maximum 12 months

Details

Condition	Respiratory Syncytial Virus Infection
Treatment	Placebo, RSV vaccine formulation 1, RSV vaccine formulation 2
Clinical Study Identifier	NCT04491877
Sponsor	Sanofi Pasteur, a Sanofi Company
Last Modified on	26 May 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Aged 6 through 18 months at Day 0
	Inclusion criteria
	Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness if required by local regulations)
	Participant and parent / guardian / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria
	Receipt of any of the following vaccines prior to enrollment
	any influenza vaccine within 7 days prior, or
	any 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
	Previous receipt of a licensed or investigational RSV vaccine or previous receipt or
	• Chronic illness may include, but is not limited to, cardiac disorders, lung
	planned administration of any anti-RSV product (such as ribavirin or RSV
	Receipt of immune globulins, blood or blood-derived products in the past 6 months prior to enrolment
	disease (including any history of reactive airway disease, receipt of
	Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
	bronchodilator therapy, or medically diagnosed wheezing), renal disorders
	Probable or confirmed case of Coronavirus Disease 2019 (COVID-19)
	Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
	auto-immune disorders, diabetes, psychomotor diseases, and known congenital or
	Any chronic illness
	genetic diseases
	Any acute febrile, respiratory or gastrointestinal illness in the past 24 hours that according to investigator judgment is significant enough to interfere with successful inoculation on the day of vaccination. ebrile event has subsided
	Any history of medically diagnosed wheezing
	Receipt of any of the following medications within 3 days prior to study enrollment (Day 0)
	Current suspected or documented developmental disorder, delay, or other developmental problem
	systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
	intranasal medications, or
	other prescription medication except as permitted concomitant medications (prescription or non-prescription) including 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
	Deprived of freedom in an emergency setting or hospitalized involuntarily
	Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
	Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days
	Any previous anaphylactic reaction
	prior to enrollment (Day 0)
	Any previous vaccine-associated adverse reaction that was Grade 3 or above. Note: if grading is not possible, determine if the reaction was considered severe or life threatening; if so, it is exclusionary
	immune immune globulins [IG] or RSV monoclonal antibody)
	Member of a household that contains, or will contain, an infant who is less than 6 months of age at the enrollment date (or in the 6 weeks preceding the first trial vaccination) through Day 28
	Member of a household that contains another child/other children who is/are, or is/are scheduled to be, enrolled in this study in the same year AND the date of enrollment will not be concurrent with the other participant(s) living in the household (i.e., all eligible children from the same household must be enrolled on the same date)
	Member of a household that contains an immunocompromised individual, including, but not limited to
	a person who is HIV infected
	a person who has received chemotherapy within the 12 months prior to enrollment
	a person receiving immunosuppressant agents
	a person living with a solid organ or bone marrow transplant
	Scheduled administration of the following after planned inoculation
	any influenza vaccine within 7 days after, or
	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
	Born at less than 34 weeks gestation
	Any previous receipt of supplemental oxygen therapy in a home or hospital setting
	Born at less than 37 weeks gestation and less than 1 year of age at the time
	except the temporary receipt of supplemental oxygen for transient tachypnea in
	newborn
	Participation at the time of study enrollment (or in the 6 weeks preceding the first
	trial vaccination) or planned participation during the present trial period in
	another clinical trial investigating a vaccine, drug, medical device, or
	medical procedure
	Attends a daycare facility and shares a daycare room with infants less than 6 months of age, and parent/guardian is unable or unwilling to suspend daycare for 28 days following inoculation
	The above information is not intended to contain all considerations relevant to a
	participant's potential participation in a clinical trial

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

vaccination

respiratory syncytial virus vaccines

Accepts healthy volunteers

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

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