Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)-RSV immunisation adaptive platform trial (PIPELINE-RSV)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondazione Penta Ets

Participant type

Pediatric, Healthy volunteers

Age range

In Utero, 0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2025-11-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

European Union Grant

External identifiers

EU CT number

2025-522194-11-00

ClinicalTrials.gov

NCT07041190

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

1. To determine if the administration of MV plus infant mAb at 4 months provides superior protection against symptomatic RSV infection in infants by 12 months of age compared with infant mAb given in the first RSV season after birth alone.
2. To determine if the administration of MV plus infant mAb at 4 months provides superior protection against symptomatic RSV infection in infants by 12 months of age compared with MV given alone.

Secondary objectives 1

1. The first secondary objective is to rank the single interventions, year-round MV and infant mAb given in the first RSV season, with respect to prevention of symptomatic RSV infection in infants by 12 months of age, and to estimate the difference between them in terms of efficacy. Further secondary objectives are to evaluate the interventions based on secondary efficacy and safety outcomes, as well as on measures of acceptability of interventions and cost-effectiveness.

Conditions and MedDRA coding

Respiratory Syncytial Virus (RSV)

Study design 1 period

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Pregnant woman - Pregnant woman.
2. Pregnant woman - Provide informed consent prior to study enrolment.
3. Pregnant woman - Willing and able (in the Site Investigator’s opinion) to comply with all study requirements.
4. Pregnant woman - Above the national legal age of consent.
5. Pregnant woman - Between 24+0 (or later as per national guidance) and 36+6 weeks gestation.
6. Pregnant woman - Able to read and complete the Participant Facing Surveys in a language in which it is available.
7. Pregnant woman - Willing to receive MV in pregnancy, if allocated.
8. Pregnant woman - Willing for the baby to receive infant mAb, if allocated.
9. Infant - Informed consent provided by the mother, and other infant legal representative (i.e. partner / co-parent) or legal guardian(s) if required by local regulations.
10. Infant - Live-birth to mother enrolled in the study.

Exclusion criteria 9

1. Pregnant woman - Major illness of the maternal participant or condition of the foetus that in the opinion of the Site Investigator would substantially increase the risk associated with the woman’s participation in and completion of the study.
2. Pregnant woman - Any suspected or confirmed condition in the foetus that in the opinion of the Site Investigator would contraindicate participation of the infant in the study.
3. Pregnant woman - High risk of prematurity as judged by treating clinician.
4. Pregnant woman - Multiple pregnancy (i.e. twins, triplets or more)
5. Pregnant woman - Previous participation in the PIPELINE-RSV trial.
6. Pregnant woman - History of Guillain Barre Syndrome.
7. Pregnant woman - Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial.
8. Pregnant woman - 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).
9. Infant - Note: all live born infants to mothers participating in the study will be included (with consent as required), but infant mAb will not be given if contraindicated.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Symptomatic RSV respiratory tract infection (RTI) in an infant, confirmed by an approved positive RSV test, by 12 months of age.

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondazione Penta Ets

Sponsor organisation

Fondazione Penta Ets

Address

Torre Di Ricerca Pediatrica, Corso Stati Uniti 4 Corso Stati Uniti 4

City

Padova

Postcode

35127

Country

Italy

Scientific contact point

Organisation

Fondazione Penta Ets

Contact name

Simon Drysdale

Public contact point

Organisation

Fondazione Penta Ets

Contact name

Giorgia Dalla Valle

Third parties 14

Locations

2 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Results and documents

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

Documents 63 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