Study of the Safety and lmmunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents

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

8 May 2025 → ongoing

Decision date (initial)

2025-03-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi Pasteur Inc

External identifiers

EU CT number

2024-512271-13-00

WHO UTN

U1111-1294-7860

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

To characterize the safety profile of PCV21 after each and any dose
Infants (7-11 months of age [MoA]) and toddlers (12-23 MoA):
- To describe the serotype specific immunoglobulin type G (IgG) antibody (Ab) level induced by 21-valent pneumococcal conjugate vaccine (PCV21) versus 20-valent pneumococcal conjugate vaccine (20vPCV) for all serotypes included in PCV21 at 30 days after the last dose, as assessed by the geometric mean concentration (GMC)
Children (2-5 years of age [YoA]):
- To describe the serotype specific opsonophagocytic activity (OPA) titer for all serotypes included in PCV21 at 30 days post-dose
- To describe the serotype specific IgG Ab level induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days post-dose, as assessed by the GMC
Children/adolescents (6-17 YoA):
- To describe the serotype specific OPA titer for all serotypes included in PCV21 at 30 days post-dose

Secondary objectives 3

1. • Children/adolescents (≥ 2 YoA): • To demonstrate the non-inferiority of serotype specific OPA titer induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days post-dose, as assessed by the geometric mean titer (GMT) • To demonstrate the non-inferiority of the serotype specific IgG Ab level induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days post-dose, as assessed by the GMC • To describe the serotype specific OPA titer for all serotypes included in PCV21 at 30 days post-dose relative to pre-dose • To describe the serotype specific IgG Ab level induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days post-dose relative to pre-dose, as assessed by the GMC • To describe the Ab response (IgG) induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days post-dose relative to pre-dose, as assessed by the seroresponse rate
2. • Infants (7-11 MoA) and toddlers (12-23 MoA): • To describe the Ab response (IgG) induced by PCV21 versus 20vPCV for all serotypes included in PCV21 at 30 days after the last dose, as assessed by the seroresponse rate
3. • In a separate subset of infants (7-11 MoA) and toddlers (12-23 MoA): • To describe the serotype specific OPA titer for all serotypes included in PCV21 at 30 days after the last dose

Conditions and MedDRA coding

Pneumococcal immunisation

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 6

1. Aged 7 months to 17 years on the day of inclusion
2. Participants who are healthy as determined by medical evaluation including medical history and physical examination
3. For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only : 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
4. For adolescents (6 to 17 YoA) only : A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: ls of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or surgically sterile. OR is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study vaccine administration until at least 4 weeks after the study vaccine administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours of before the first dose of study vaccine.
5. Assent form has been signed and dated by the participant (based on local regulations), and if applicable, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations
6. Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures

Exclusion criteria 16

1. 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
2. History of microbiologically confirmed S. pneumoniae infection or disease
3. History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy
4. Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a product containing any of the same substances
5. Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent(s) / LAR(s), contraindicating intramuscular (IM) injection
6. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
7. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
8. Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature 38.0°C [100.4°F]) on the day of vaccine administration.
9. For infants (7 to 11 MoA) and toddlers (12 to 23 MoA) only : Previous vaccination against S. pneumonia
10. For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only : previous vaccination with pneumococcal polysaccharide vaccine
11. For adolescents (6 to 17 YoA) only : Alcohol, prescription drug, or substance abuse that, in the opinion of the lnvestigator, might interfere with the study conduct or completion
12. Receipt of any vaccine in the 4 weeks preceding the vaccine administration or planned receipt of any vaccine in the 4 weeks following the vaccine administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations
13. Receipt of immune globulins, blood or blood-derived products in the past 3 months
14. For children (2 to 5 YoA) and adolescents (6 to 17 YoA) only : Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
15. Participation at the time of study enrollment (or in the 6 weeks preceding the first vaccine administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
16. For adolescents (6 to 17 YoA) only • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily • ldentified as an lnvestigator or employee of the lnvestigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted chiId) of the lnvestigator or employee with direct involvement in the proposed study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 8

1. Number of participants reporting immediate adverse events (AEs)
2. Number of participants reporting solicited injection site and solicited systemic reactions
3. Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after each and any injection of a pneumococcal vaccine
4. Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESls)
5. Number of Infants (7-11 months of age [MoA]) and toddlers (12-23 MoA): with serotype-specific lgG concentrations for all serotypes included in PCV21
6. Number of Children (2-5 years of age [YoA]):with serotype specific OPA titers for all serotypes included in PCV21
7. Number of Children (2-5 years of age [YoA]):with serotype specific lgG concentrations for all serotypes included in PCV21
8. Number of Children/adolescents (6-17 YoA):with serotype specific OPA titers for all serotypes included in PCV21

Secondary endpoints 6

1. Number of Children/adolescents (≥2 YoA) with serotype specific OPA titers for all serotypes included in PCV 21
2. Number of Children/adolescents (≥2 YoA): with serotype specific lgG concentrations for all serotypes included in PCV21
3. Number of participants (all age groups) with serotype specific lgG concentration ≥ 0.35 µg/ml for all serotypes included in PCV21
4. Number of infants (7-11 MoA) and toddlers(12-23 MoA):with serotype specific OPA titers for all serotypes included in PCV21
5. Percentage of infants (7-11 MoA) and toddlers(12-23 MoA): with serotype specific OPA titers ≥ LLOQ for all serotypes included in PCV21
6. Number of Children/adolescents (6-17 YoA):with serotype specific lgG concentrations for all serotypes included in PCV21

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 4

Locations

2 EU/EEA countries · 15 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 51 files

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

Application history

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