A Phase 2 Safety and Immunogenicity Study of a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers

Start 2 Nov 2023 · End 28 May 2024 · Status Ended · 2 EU/EEA countries · 16 sites · Protocol C4801002

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ended

Participants planned 100

Countries 2

Sites 16

Pneumococcal Infections

To describe the safety profile of the mPnC candidate administered as a 2-dose series in children ≥11 to ≤15 months of age.

Key facts

Sponsor: Pfizer Inc.
Participant type: Pediatric, Healthy volunteers
Age range: 0-17 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration: 2 Nov 2023 → 28 May 2024
Decision date (initial): 2023-10-19
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Pfizer Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To describe the safety profile of the mPnC candidate administered as a 2-dose series in children ≥11 to ≤15 months of age.

Secondary objectives 1

To describe the immune responses elicited by the mPnC candidate.

Conditions and MedDRA coding

Pneumococcal Infections

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

Toddlers ≥11 and ≤15 months of age at the time of consent.
Have received exactly 2 infant doses of PCV10 according to a local immunization schedule.
Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion criteria 5

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of study intervention, 13vPnC, 20vPnC, or any diphtheria toxoid–containing vaccine.
Significant neurological disorder or history of seizure (excluding febrile seizure) or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders.
Major known congenital malformation or serious chronic disorder.
History of microbiologically proven invasive disease caused by S pneumoniae.
Previous vaccination with any licensed pneumococcal vaccine (other than the PCV10 primary infant series) or investigational pneumococcal vaccine, or planned receipt of nonstudy pneumococcal vaccine during study participation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

Prompted local reactions (redness, swelling, and pain at the injection site)
Prompted systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability)
Adverse events (AEs)
Serious adverse events (SAEs)

Secondary endpoints 2

Immunoglobulin G (IgG) concentrations for the candidate serotype
Opsonophagocytic activity (OPA) titers for the candidate serotype

Investigational products

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

Test 1

PF-07831695

PRD10480606 · Product

Active substance: PF-07831695
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR USE
Max daily dose: 0.5 ml millilitre(s)
Max total dose: 1 ml millilitre(s)
Max treatment duration: 2 Day(s)
Authorisation status: Not Authorised
MA holder: PFIZER INC.
Paediatric formulation: No
Orphan designation: No

Comparator 1

Pneumococcal Polysaccharide Serotype 3 Conjugated to CRM197 Adsorbed on Aluminium Phosphate

SUB199854 · Substance

Active substance: Pneumococcal Polysaccharide Serotype 3 Conjugated to CRM197 Adsorbed on Aluminium Phosphate
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR USE
Max daily dose: 0.5 ml millilitre(s)
Max total dose: 1 ml millilitre(s)
Max treatment duration: 2 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 6

Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)

PRD333987 · Product

Active substance: Pneumococcal Polysaccharide Serotype 1 Conjugated to Protein D (Derived From Non-Typeable Haemophilus Influenzae) Carrier Protein Adsorbed on Aluminium Phosphate
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR USE
Max daily dose: 0.5 ml millilitre(s)
Max total dose: 1.5 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J07AL52 — -
Marketing authorisation: EU/1/09/508/002
MA holder: GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)

PRD333952 · Product

Active substance: Pneumococcal Polysaccharide Serotype 1 Conjugated to Protein D (Derived From Non-Typeable Haemophilus Influenzae) Carrier Protein Adsorbed on Aluminium Phosphate
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR USE
Max daily dose: 0.5 ml millilitre(s)
Max total dose: 1.5 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J07AL52 — -
Marketing authorisation: EU/1/09/508/001
MA holder: GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)

PRD334228 · Product

Active substance: Pneumococcal Polysaccharide Serotype 1 Conjugated to Protein D (Derived From Non-Typeable Haemophilus Influenzae) Carrier Protein Adsorbed on Aluminium Phosphate
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR USE
Max daily dose: 0.5 ml millilitre(s)
Max total dose: 1.5 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J07AL52 — -
Marketing authorisation: EU/1/09/508/010
MA holder: GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)

PRD334042 · Product

Active substance: Pneumococcal Polysaccharide Serotype 1 Conjugated to Protein D (Derived From Non-Typeable Haemophilus Influenzae) Carrier Protein Adsorbed on Aluminium Phosphate
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR USE
Max daily dose: 0.5 ml millilitre(s)
Max total dose: 1.5 ml millilitre(s)
Max treatment duration: 1 Week(s)
Authorisation status: Authorised
ATC code: J07AL52 — -
Marketing authorisation: EU/1/09/508/003
MA holder: GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)

PRD334115 · Product

Active substance: Pneumococcal Polysaccharide Serotype 1 Conjugated to Protein D (Derived From Non-Typeable Haemophilus Influenzae) Carrier Protein Adsorbed on Aluminium Phosphate
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR USE
Max daily dose: 0.5 ml millilitre(s)
Max total dose: 1.5 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J07AL52 — -
Marketing authorisation: EU/1/09/508/005
MA holder: GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)

PRD334095 · Product

Active substance: Pneumococcal Polysaccharide Serotype 1 Conjugated to Protein D (Derived From Non-Typeable Haemophilus Influenzae) Carrier Protein Adsorbed on Aluminium Phosphate
Pharmaceutical form: SUSPENSION FOR INJECTION
Route of administration: INTRAMUSCULAR USE
Max daily dose: 0.5 ml millilitre(s)
Max total dose: 1.5 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J07AL52 — -
Marketing authorisation: EU/1/09/508/004
MA holder: GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation: Pfizer Inc.
Address: 235 East 42nd Street
City: New York
Postcode: 10017-5703
Country: United States

Scientific contact point

Organisation: Pfizer Inc.
Contact name: Clinical Medical Lead

Public contact point

Organisation: Pfizer Inc.
Contact name: Clinical Medical Lead

Third parties 3

Organisation	City, country	Duties
Yprime LLC ORG-100042888	Malvern, United States	Other
Innovative Trials Limited ORG-100044081	Letchworth Garden City, United Kingdom	Other
Icon Public Limited Company ORG-100042517	Dublin 18, Ireland	On site monitoring

Locations

2 EU/EEA countries · 16 investigational sites

By country

Country	MS status	Planned subjects	Sites
Finland	Ended	50	9
Poland	Ended	50	7
Rest of world	—	0	—