Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants from Approximately 2 Months of Age

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi Pasteur Inc.

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

22 May 2025 → ongoing

Decision date (initial)

2025-03-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi Pasteur Inc

External identifiers

EU CT number

2023-507600-32-00

WHO UTN

U1111-1301-4082

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Safety, Others

• To demonstrate the non-inferiority of the antibody (Ab) response (immunoglobulin type G [IgG]) induced by PCV21 versus 15vPCV for the shared serotypes between 15vPCV and PCV21 at 30 days post-toddler dose (PTD) (post dose [PD]3 for full-term infants; PD4 for preterm infants), as assessed by the seroresponse rate
• To demonstrate the non-inferiority of the serotype specific IgG Ab level induced by PCV21 versus 15vPCV for the shared serotypes between 15vPCV and PCV21 at 30 days PTD, as assessed by the geometric mean concentration (GMC)
• To demonstrate the superiority of the Ab response (IgG) induced by PCV21 versus 15vPCV for the 6 serotypes unique to PCV21 at 30 days PTD, as assessed by the seroresponse rate
• To demonstrate the superiority of the serotype specific IgG Ab level induced by PCV21 versus 15vPCV for the 6 serotypes unique to PCV21 at 30 days PTD, as assessed by the GMC

Secondary objectives 9

1. To demonstrate the non-inferiority of the immune response of the routine pediatric vaccines administered concomitantly with PCV21 versus 15vPCV at 30 days PTD, in a subset of participants
2. To demonstrate the non-inferiority of the serotype specific IgG Ab level induced by PCV21 versus 15vPCV for the shared serotypes between 15vPCV and PCV21 at 30 days post-primary series (PPS) (PD2 for full-term infants and PD3 for preterm infants), as assessed by the GMC
3. To demonstrate the superiority of the serotype specific IgG Ab level induced by PCV21 versus 15vPCV for the 6 serotypes unique to PCV21 at 30 days PPS, as assessed by the GMC
4. To describe the Ab response (IgG) induced for all serotypes included in PCV21 at 30 days PPS, as assessed by the seroresponse rate
5. To describe the serotype specific IgG Ab level for all serotypes included in PCV21 at 30 days PTD relative to pre-toddler dose, as assessed by the GMC
6. To describe the immune response of the routine pediatric vaccines administered concomitantly with PCV21 versus 15vPCV at 30 days PPS, in a subset of participants
7. To describe the serotype specific opsonophagocytic activity (OPA) titer for all serotypes included in PCV21 at 30 days PPS and PTD, in a subset of participants
8. To describe the serotype specific OPA titer for all serotypes included in PCV21 at 30 days PTD relative to pre-toddler dose, in a subset of participants
9. To characterize the safety profile of PCV21 after each and any dose

Conditions and MedDRA coding

Pneumococcal Immunization

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-002780-PIP02-20

Plan to share IPD

Yes

IPD plan description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Aged 42 to 112 days on the day of inclusion
2. Participants who are healthy as determined by medical evaluation including medical history and physical examination
3. Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable as assessed by the investigator

Exclusion criteria 15

1. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
2. History of microbiologically confirmed Streptococcus pneumoniae infection or disease
3. Any contraindication to the routine pediatric vaccines being administered in the study
4. History of seizure or significant stable or progressive neurological disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
5. Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
6. Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally acceptable representative (LAR), contraindicating intramuscular (IM) injection
7. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
8. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
9. Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
10. Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for oral rotavirus vaccine, which may be received anytime during the study including at study visits and for influenza vaccination or meningococcal b vaccine, which may be received at least 14 days before or 14 days after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.
11. Previous vaccination against S. pneumoniae
12. Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and poliovirus
13. Receipt of more than 1 dose of hepatitis B vaccine
14. Receipt of immune globulins, blood or blood-derived products since birth
15. Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Seroresponse rate for PCV21 and 15vPCV serotypes
2. IgG concentration for PCV21 and 15vPCV serotypes

Secondary endpoints 23

1. Anti- hepatitis B surface antigen (HBsAg) Ab
2. Anti- polyribosylribitol phosphate (PRP) Ab
3. Anti-poliovirus types (1, 2, and 3) Ab
4. Anti-diphtheria Ab concentrations
5. Anti-tetanus Ab concentrations
6. Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))
7. Anti-measles Ab concentrations
8. Anti-mumps Ab concentrations
9. Anti-rubella Ab concentrations
10. Anti-varicella Ab concentrations
11. Anti HBsAg concentrations
12. Anti-PRP Ab concentrations
13. Anti-poliovirus types (1, 2, and 3) Ab titers
14. Anti-diphtheria Ab concentrations
15. Anti-tetanus Ab concentrations
16. Anti-pertussis Ab concentrations (PT and FHA)
17. Serotype specific OPA titers for all serotypes included in PCV21
18. Serotype specific OPA titers for all serotypes included in PCV21
19. Presence of any immediate adverse events (AEs)
20. Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
21. Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection
22. Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)
23. Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi Pasteur Inc.

Sponsor organisation

Sanofi Pasteur Inc.

Address

1 Discovery Drive

City

Swiftwater

Postcode

18370-9100

Country

United States

Scientific contact point

Organisation

Sanofi Pasteur Inc.

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi Pasteur Inc.

Contact name

Clinical Sciences and Operations

Third parties 7

Locations

9 EU/EEA countries · 60 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 105 files

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

Application history

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