Phase 2
N=259
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Respiratory Syncytial Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04491877 ↗Enrolled (actual)
259
Serious AEs
2.7%
Results posted
Jun 2024
Primary outcome: Primary: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RSV vaccine formulation 1 (Biological); RSV vaccine formulation 2 (Biological); Placebo (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Solicited Administration Site and Systemic Reactions |
15; 12; 8; 7; 9; 6 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events |
6; 2; 2; 5; 0; 2 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest (AESIs) |
3; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Medically Attended Adverse Events (MAAEs) |
3; 1; 0; 4; 0; 1 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
0; 0; 1; 0; 0; 1 | — |
| PRIMARY Geometric Mean Titers Against RSV A Neutralizing Antibody in RSV-Naïve Participants |
75.9; 32.8; 180; 27.5; 99.2; 17.9 | — |
| SECONDARY Titer of Vaccine Virus Shedding Measured by Reverse Transcription Polymerase Chain Reaction (RT-PCR) |
5.02; 6.27; 5.82; 5.16; 5.21; 5.35 | — |
| SECONDARY Percentage of Participants Infected With Vaccine Virus at Days 56 and 84 |
82.4; 12.5; 100; 0; 100; 0 | — |
| SECONDARY Geometric Mean Titers Against RSV A Neutralizing Antibody in RSV-Experienced Participants |
134; 52.1; 672; 409; 15.0; 120 | — |
| SECONDARY Geometric Mean Titers Against Serum Anti-F Immunoglobulin G (IgG) Antibody |
32.8; 15.0; 58.8; 8.63; 48.7; 7.50 | — |
| SECONDARY Geometric Mean Titers Against RSV A Neutralizing Antibody After the RSV Surveillance Season |
73.2; 24.4; 303; 16.6; 294; 108 | — |
| SECONDARY Geometric Mean Titers Against Serum Anti-F Immunoglobulin G Antibody After the RSV Surveillance Season |
63.7; 14.2; 388; 8.63; 296; 272 | — |
Summary
The primary objectives of the study were:
* 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 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-naïve participants.
The secondary objectives of the study were:
* To quantify the amount of vaccine virus shed by each participant by baseline serostatus.
* To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus.
* To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants.
* To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline 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 serostatus.
Eligibility Criteria
Inclusion Criteria
Inclusion criteria
- Aged 6 through 18 months at Day 0.
- 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
- Born at less than 34 weeks gestation
- Born at less than 37 weeks gestation and less than 1 year of age at the time
- 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).
- 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
- Any chronic illness
- Chronic illness may include, but is not limited to, cardiac disorders, lung disease (including any history of reactive airway disease, receipt of bronchodilator therapy, or medically diagnosed wheezing), renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases
- Any history of medically diagnosed wheezing
- 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. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Any previous anaphylactic reaction
- Current suspected or documented developmental disorder, delay, or other developmental problem
- 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 planned administration of any anti-RSV product (such as ribavirin or RSV immune immune globulins [IG] or RSV monoclonal antibody)
- Receipt of immune globulins, blood or blood-derived products in the past 6 months prior to enrolment
- Receipt of any of the following medications within 3 days prior to study enrollment (Day 0):
- 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
- Receipt of salicylate (aspirin) or salicylate-containing products within the 28 days 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.
- 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.
- Any previous receipt of supplemental oxygen therapy
Data sourced from ClinicalTrials.gov (NCT04491877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.