PIPELINE-RSV-France

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Annecy Genevois

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Health Care [N] - Health Care Economics and Organizations [N03], Diseases [C] - Virus Diseases [C02], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

28 Apr 2026 → ongoing

Decision date (initial)

2025-10-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS (AAP ANRS RECH-MIE / ECTZ299088)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To determine, in the French context, if the administration of maternal RSV vaccine Abrysvo (administered all year round between 32 and 36 weeks’ gestation + 6 days) PLUS nirsevimab (administered all year round at 4 months (+/- 1 month) is more efficacious (superiority testing) than seasonal nirsevimab (given to infants entering their first RSV season, i.e at birth for children born during the season or at the beginning of the epidemic for other infants) in preventing symptomatic RSV infections in infants during the first year of life.

Secondary objectives 5

1. To evaluate the interventions based on secondary efficacy and safety outcomes
2. To evaluate the interventions based on measures of acceptability of interventions and cost-effectiveness
3. To examine the impact of seasonality, of the timing of maternal vaccine, gestational age at birth and the co-administration of other maternal vaccines on the efficacy of the interventions
4. To estimate the relative efficacy of interventions, by analysing data from PIPELINE-RSV-France trial with data from PIPELINE-RSV-International trial
5. To rank the single interventions, year-round maternal vaccine in pregnancy and seasonal infant nirsevimab administered in the first RSV season following birth, with respect to prevention of symptomatic RSV infection in infants by 12 months of age, by analysing data from PIPELINE-RSV-France trial with data from PIPELINE-RSV-International trial

Conditions and MedDRA coding

Respiratory syncytial virus infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Pregnant women
2. Provide informed consent prior to study enrolment
3. Willing and able (in the site investigator’s opinion) to comply with all study requirements
4. More than 18 years of age
5. Between 32 and 36 weeks + 6 days of gestation
6. Able to read and complete the eHealth questionnaire in French or English
7. Willing to receive maternal vaccine in pregnancy, if allocated
8. Willing for the baby to receive infant nirsevimab
9. Willing for their data to be re-used as part of the joint analysis with PIPELINE-RSV-International trial
10. Affiliated to social security regime or an equivalent system
11. Live-birth to mother enrolled in the study
12. Informed consent from the mother, and the other legal representative (partner / co-parent) when applicable

Exclusion criteria 8

1. Major illness of the maternal participant or conditions of the foetus that, in the investigator’s judgment, would substantially increase the risk associated with the maternal or infant participant’s participation in and completion of the study
2. Any suspected or confirmed condition in the foetus that in the opinion of the site investigator would contraindicate participation of the future newborn/infant in the study
3. High risk of prematurity as judged by treating clinician
4. Multiple pregnancy (i.e. twins, triplets or more).
5. Previous participation in the PIPELINE-RSV trial
6. Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial
7. Any contraindication for receipt of intramuscular injection (bleeding diathesis or a condition associated with prolonged bleeding) or of vaccine (history of severe allergic reaction, e.g. anaphylaxis, to any component of the vaccine)
8. History of Guillain Barré Syndrome (GBS)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Symptomatic RSV respiratory tract infection (RTI) by 12 months of age, confirmed by an approved positive RSV test: RSV reverse transcription polymerase chain reaction (RT-PCR) or a positive RSV antigen test on nasal swabs (fitting for infants) performed in a protocol-approved central or local laboratory. Parents will be encouraged to carry out an RT-PCR test in the event of running or blocked nose, cough, wheeze, or difficulty breathing.

Secondary endpoints 19

1. RSV RTI by 3 and 6 months of age
2. Medically-attended (MA)-RSV RTI by 3, 6 and 12 months of age
3. RSV RTI-associated hospitalisations by 3, 6 and 12 months of age
4. RSV RTI with SpO2 <90% and/or with need for supplemental O2
5. RSV RTI-associated deaths by 12 months of age
6. All-cause RTI by 3, 6 and 12 months of age
7. All-cause medically attended respiratory tract infections (MA-RTI) by 3, 6 and 12 months of age
8. All-cause RTI-associated hospitalisations by 3, 6 and 12 months of age
9. All-cause RTI with SpO2 <90% and/or with need for supplemental O2 by 3, 6 and 12 months of age
10. All-cause RTI-associated deaths by 12 months of age
11. MA wheezing with 1 or more episodes by 12 months
12. RT-PCR Cycle threshold (Ct) value overall and by RSV subtype (RSV-A or RSV-B) for RSV-infection confirmed by RT-PCR by 12 months of age
13. Serious adverse events (SAEs), grade ≥3 AEs by 12 months of age
14. All-cause MA-RTI by 12 months post-delivery
15. SAEs by 12 months post-delivery
16. Pregnancy loss (miscarriage and stillbirth)
17. Preterm (<37 weeks’ gestation) delivery
18. Infant low birth weight (<2500g)
19. Acceptability of trial interventions and procedures

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Annecy Genevois

Sponsor organisation

Centre Hospitalier Annecy Genevois

Address

1 Avenue De L Hopital, Bp 90074 Bp 90074

City

Epagny Metz Tessy

Postcode

74370

Country

France

Scientific contact point

Organisation

Centre Hospitalier Annecy Genevois

Contact name

Tristan DELORY

Public contact point

Organisation

Centre Hospitalier Annecy Genevois

Contact name

Marie-Claire PARRIAULT

Locations

1 EU/EEA country · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications