RSV Vaccine for Infants and Toddlers

(CORAL Trial)

Not currently recruiting at 174 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunodeficiency, Chronic illness, Wheezing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine for RSV, a virus that causes lung infections in infants and toddlers. The researchers aim to determine if the vaccine is effective when administered alongside other routine vaccines at various ages. Healthy infants who have received their routine vaccines and are around 6 or 12 months old may be suitable candidates. The trial includes different groups to compare vaccine timing and effectiveness. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking RSV vaccine.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you have received immunosuppressive therapy, long-term systemic corticosteroids, or certain vaccines recently. Check with the trial team for specific guidance.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like immunosuppressive therapy or systemic corticosteroids may affect eligibility, so it's best to discuss your specific situation with the trial team.

Is there any evidence suggesting that the RSVt vaccine is likely to be safe for infants and toddlers?

Research shows that the RSVt vaccine is generally safe for infants and toddlers. Earlier studies found that the vaccine creates a strong immune response without causing serious side effects, meaning children in these studies did not experience major health issues from the vaccine.

While more information is being gathered, the vaccine's progression to a Phase 3 trial indicates that earlier trials deemed it safe enough for testing in larger groups of children. This phase primarily evaluates the vaccine's safety and effectiveness in a broader population. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the RSVt vaccine for infants and toddlers because it offers a new approach to preventing RSV infections, a common respiratory virus in young children. Unlike standard treatments, which primarily focus on managing symptoms and supportive care, the RSVt vaccine aims to prevent the infection from occurring in the first place. This vaccine is particularly promising as it can be given alongside routine pediatric vaccines, potentially increasing vaccination rates and coverage. By integrating RSV prevention into the existing immunization schedule, the RSVt vaccine has the potential to significantly reduce the incidence of RSV-related illnesses in this vulnerable age group.

What evidence suggests that the RSVt vaccine could be effective for infants and toddlers?

Research has shown that RSV vaccines can protect infants and toddlers from respiratory syncytial virus (RSV). One study found that a similar RSV vaccine was 90% effective in preventing hospital stays due to RSV in infants during their first RSV season. Another study indicated that RSV vaccines reduced the need for antibiotics for lower respiratory infections, with an effectiveness of about 16.9%. This trial will evaluate the RSVt vaccine, administered either concomitantly or non-concomitantly with routine pediatric vaccines, to assess its potential in reducing RSV-related illnesses in young children. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy infants and toddlers who are either 6 months + 2 weeks or 12 months ± 2 weeks old, born at full term (≥37 weeks). In the US/Puerto Rico, they must have received specific routine vaccines on schedule before joining. Infants with health issues or not meeting vaccine timelines are excluded.

Inclusion Criteria

Born at full term of pregnancy (≥ 37 weeks)

Participants who are healthy as determined by medical evaluation including medical history and physical examination

I am at least 6 months and 2 weeks old for Cohort 1 or 12 months old (plus or minus 2 weeks) for Cohort 2.

Exclusion Criteria

Known systemic hypersensitivity to study intervention components or history of life-threatening reaction to study intervention

Chronic illness that might interfere with study conduct or completion

Receipt of vaccines or products within specified timeframes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RSVt vaccine concomitantly or non-concomitantly with routine pediatric vaccines

9 months

Cohort 1: Visits at 6, 7, 8, 9, and 10 months; Cohort 2: Visits at 12, 13, 14, 15, and 16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RSVt vaccine

Trial Overview The study tests if the RSVt vaccine's effectiveness is unaffected when given alongside standard childhood vaccines like DTP, IPV, Hib, HepB, rotavirus and pneumococcal conjugate vaccines at ages of approximately 6 and 12 months compared to giving it separately.

How Is the Trial Designed?

Group I: Cohort 2: Group 4- (RSVt vaccine non-concomitantly at 13 months) Experimental Treatment 5 Interventions

Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 13 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered concomitantly at 12 months of age

Group II: Cohort 2: Group 3- (RSVt vaccine concomitantly at 12 months) Experimental Treatment 5 Interventions

Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 12 months. Vaccines administered at age 6 months: M-M-R II, VARIVAX, and Prevnar 20. Placebo will be administered non-concomitantly at 13 months of age

Group III: Cohort 1: Group 2- (RSVt vaccine non-concomitantly at 7 months) Experimental Treatment 7 Interventions

Participants will be administered RSVt vaccine non-concomitantly with routine pediatric vaccines, 2 doses, at age 7 months. Vaccines administered at age 6 months: Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered concomitantly at 6 months of age

Group IV: Cohort 1: Group 1- (RSVt vaccine concomitantly at 6 months) Experimental Treatment 7 Interventions

Participants will be administered RSVt vaccine concomitantly with routine pediatric vaccines, 2 doses, at age 6 months. Vaccines administered at age 6 months: RSVt Vaxelis or Pentacel and Recombivax HB, Prevnar 20, and RotaTeq. Placebo will be administered non-concomitantly at 7 months of age

RSVt vaccine is already approved in United States for the following indications:

Approved in United States as Abrysvo for:

• Lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older
• LRTD caused by RSV in pregnant women from 32 through 36 weeks gestation to protect newborns up to 6 months old
• LRTD caused by RSV in adults aged 18 through 59 years at higher risk

Approved in United States as Arexvy for:

• Lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older
• LRTD caused by RSV in adults aged 50 through 59 years at increased risk

Approved in United States as mRESVIA for:

• Lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Published Research Related to This Trial

Despite over 60 years of effort, the only current preventive measure against respiratory syncytial virus (RSV) in Canada is a monoclonal antibody for high-risk infants, highlighting the urgent need for an effective vaccine.

Recent advancements in cellular immunology and protein structure have led to 121 clinical trials by 16 organizations, focusing on various vaccine technologies, including live-attenuated and subunit-based vaccines, indicating a promising future for RSV prevention in the next decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the respiratory syncytial virus vaccine candidate pipeline in Canada. Killikelly, A., Tunis, M., House, A., et al.[2021]

The Gcf A/Bac M2 vaccine candidate successfully induced strong Th1 and CD8+ T-cell responses in mice, leading to effective protective immunity against respiratory syncytial virus (RSV) without causing vaccine-enhanced disease (VED).

This vaccine formulation also resulted in a significant increase in IgG responses compared to Gcf A alone, suggesting that Bac M2 acts as an effective adjuvant, enhancing the immune response to RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine containing G protein fragment and recombinant baculovirus expressing M2 protein induces protective immunity to respiratory syncytial virus. Jo, YM., Kim, J., Chang, J.[2022]

The RSV-PreF vaccine demonstrated strong immunogenicity, significantly increasing neutralizing antibody levels against RSV-A and RSV-B in healthy nonpregnant women, with the highest dose (120 µg) showing the greatest antibody response.

The vaccine was well-tolerated with no serious adverse events related to it, indicating a favorable safety profile for future use in pregnant women to potentially protect infants from RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and Safety of 3 Formulations of a Respiratory Syncytial Virus Candidate Vaccine in Nonpregnant Women: A Phase 2, Randomized Trial. Schwarz, TF., McPhee, RA., Launay, O., et al.[2020]

Respiratory syncytial virus (RSV) is a major cause of severe respiratory infections in infants, and developing a safe and effective vaccine is challenging due to incomplete immunity from natural infections and the immature immune systems of newborns.

Current promising strategies for RSV vaccination include intranasally delivered genetically engineered vaccines that aim to induce a balanced immune response, as well as maternal vaccination to protect infants from RSV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunopathology of RSV infection: prospects for developing vaccines without this complication. van Drunen Littel-van den Hurk, S., Mapletoft, JW., Arsic, N., et al.[2008]

Respiratory syncytial virus (RSV) is a significant cause of illness and death in children, highlighting the urgent need for an effective vaccine.

Recent advancements in molecular technologies have improved the safety of live-attenuated vaccines, and protein-based vaccines are showing promise in clinical trials for both RSV-primed individuals and maternal vaccination to protect infants early in life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory syncytial virus vaccine: Is it coming? Sales, V., Wang, EE.[2021]

The investigational ChAd155-RSV vaccine was found to have a safety profile similar to other childhood vaccines, with most adverse events occurring at rates comparable to or lower than those of active comparators.

The vaccine induced a strong immune response in infants, with higher RSV neutralizing titers and antibody concentrations compared to the comparator group, and there was no evidence of vaccine-associated enhanced respiratory disease (VAERD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6-7 months of age: a phase 1/2 randomized trial. Sáez-Llorens, X., Norero, X., Mussi-Pinhata, MM., et al.[2023]

Respiratory Syncytial Virus (RSV) is a major cause of severe respiratory illness in infants and vulnerable populations, highlighting the urgent need for effective vaccines.

Current clinical trials are exploring various RSV vaccine candidates across different age groups, including infants, children, pregnant women, and the elderly, aiming to improve prevention strategies against this widespread virus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multifaceted approach to RSV vaccination. Blanco, JCG., Boukhvalova, MS., Morrison, TG., et al.[2020]

The study evaluated an adjuvanted RSV vaccine in 1900 adults aged 60 and older, using a reliable patient-reported outcome tool (FLU-PRO) to assess RSV disease symptoms and virologic confirmation, demonstrating the tool's effectiveness in capturing relevant data.

Self-collection of nasal swabs significantly improved the detection of RSV cases, identifying 9 additional cases that site-swabbing alone would have missed, highlighting the importance of participant engagement in monitoring respiratory illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Efficacy Endpoints for a Phase IIb Study of a Respiratory Syncytial Virus Vaccine in Older Adults Using Patient-Reported Outcomes With Laboratory Confirmation. Yu, J., Powers, JH., Vallo, D., et al.[2020]

A mathematical model suggests that maternal vaccination against RSV at 30 weeks of pregnancy could prevent 62-75% of RSV-related pediatric intensive care unit admissions in the UK and 76-87% in the Netherlands, indicating a significant potential impact on infant health.

The model also predicts that maternal vaccination could reduce RSV-related in-hospital deaths globally by 29-48%, although preterm infants and those with comorbidities may benefit less than healthy term infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential impact of maternal vaccination on life-threatening respiratory syncytial virus infection during infancy. Scheltema, NM., Kavelaars, XM., Thorburn, K., et al.[2018]

Respiratory syncytial virus (RSV) can cause severe respiratory illness in infants and is also a significant health risk for older adults, highlighting the need for effective prevention strategies.

Despite past failures in developing safe and effective RSV vaccines, current research is focusing on innovative approaches, including subunit vaccines and genetically engineered live attenuated vaccines, to improve immunogenicity and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with respiratory syncytial virus vaccines. Piedra, PA.[2005]

Respiratory syncytial virus (RSV) is a major cause of respiratory illness, particularly in high-risk groups like infants and the elderly, yet there is currently no approved vaccine for prevention.

Early vaccine attempts using inactivated virus led to severe complications in children, highlighting the need for careful development; recent strategies include live attenuated strains and various innovative vaccine technologies, showing cautious progress over the past 40 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory syncytial virus vaccine development. Murata, Y.[2021]

The Ad26.RSV.preF vaccine candidate showed good safety and immunogenicity in a study involving 12 adults and 36 RSV-seropositive children, with no serious adverse events reported and only mild to moderate reactions observed.

The vaccine significantly increased RSV neutralization titers in children and resulted in fewer RSV infections compared to the placebo group, indicating its potential effectiveness in preventing RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months. Stuart, ASV., Virta, M., Williams, K., et al.[2023]

Citations

1. cdc.gov cdc.gov/media/releases/2024/s0307-rsv-immunization.html

CDC study shows effectiveness of RSV immunization for ... Results show that nirsevimab was 90% effective at preventing RSV-associated hospitalization in infants during their first RSV season.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10864603/

Efficacy and safety of respiratory syncytial virus vaccination ... The vaccine's efficacy against antimicrobial prescriptions associated with LRTI was 16.9% (95% CI: 1.4%–29.4%). These findings indicate that RSV plays a ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41016728/

Efficacy and safety of respiratory syncytial virus vaccines Authors' conclusions: RSV prefusion vaccines reduced RSV-associated lower respiratory tract illness and acute respiratory illness in older ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1201971224001899

Efficacy and safety of vaccines to prevent respiratory ... For maternal vaccination, the RSV vaccine showed favourable efficacy against RSV-related LRTD (vaccine efficacy 57.3%, 95% confidence interval [CI] 31.3-73.5; ...

5. publications.aap.org publications.aap.org/pediatrics/article/155/6/e2024070240/201878/Infant-Respiratory-Syncytial-Virus-Immunization

Infant Respiratory Syncytial Virus Immunization Coverage ... Overall, 72% of infants were immunized against RSV; estimates were highest among infants born to non-Hispanic (NH) Asian mothers (84%).

6. cdc.gov cdc.gov/vaccine-safety/vaccines/rsv.html

Respiratory Syncytial Virus (RSV) Vaccine Safety Because of its recent introduction, post-licensure safety data are not yet available for this vaccine, which is currently being monitored in V- ...

7. cdc.gov cdc.gov/rsv/hcp/vaccine-clinical-guidance/infants-young-children.html

RSV Immunization Guidance for Infants and Young Children Respiratory Syncytial Virus (RSV) Vaccine Safety. Learn safety information about the Respiratory Syncytial Virus (RSV) vaccine. July 11, 2025 ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40856556/

Live-Attenuated Intranasal RSV Vaccine in Infants and ... The RSVt vaccine demonstrated promising immunogenicity profiles at both LD and HD strengths among infants and toddlers, without identified safety concerns.

9. evidence.nejm.org evidence.nejm.org/doi/abs/10.1056/EVIDoa2500026

Live-Attenuated Intranasal RSV Vaccine in Infants and Toddlers The RSVt vaccine demonstrated promising immunogenicity profiles at both LD and HD strengths among infants and toddlers, without identified ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06705140

NCT06705140 | A Study on the Immunogenicity and Safety ... ... Safety of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers (OPAL) ... Presence of RSVt vaccine virus viral shedding in D08 and D64 nasal samples ...