Evaluation of the Non-Inferiority of a 12-Valent Pneumococcal Conjugate Vaccine in Healthy Children in Brazil.

NCT05721456 | Unknown Phase 3

• 1 other identifier: Protocol ASCLIN 002/2022
• Study Type: interventional
• Target: 2,400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this phase III study is to demonstrate immunologic non-inferiority in terms of proportion of individuals with antibody concentration ≥0.2 µg/mL (by modified 22F-inhibition enzyme-linked immunosorbent assay, ELISA) or in terms of ELISA geometric mean concentrations (GMC) of serotype-specific IgG, of 12-valent pneumococcal polysaccharide conjugate vaccine (12Pn-PD-DiT-CRM, hereby indicated as PCV12), containing the serotypes 1, 4, 5, 6B, 7F, 9V, 14, and 23F conjugated with non-typeable Haemophilus influenzae protein D, 19F conjugated with TD, 18C conjugated with TT, and 6A and 19A conjugated with CRM197, and to assess its safety in the population of infants vaccinated from 2 months of age with a primary regimen of 2 or 3 doses plus a booster administered at one year of life.

Conditions

Pneumococcal Vaccines

Outcome Measures

Primary Outcomes (1)

• The immunological non-inferiority of pneumococcal vaccine 12 in relation to pneumococcal vaccine 10 and 13.

  Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥0.20 µg/mL after primary vaccination.Geometric mean concentrations of serotype-specific pneumococcal IgG antibody after primary vaccination.

  5 months

Secondary Outcomes (4)

• Functional Antibody Response

  17 months

• Immunogenicity after booster

  17 months

• Safety and reactogenicity vaccination and booster vaccination.

  18 months

• Immunogenicity, safety and reactogenicity co-administered vaccines

  17 months

Study Arms (3)

PCV10 (Synflorix®)

ACTIVE COMPARATOR

Biological: 12-Valent Pneumococcal Conjugate Vaccine

PCV13 (Prevenar13®)

ACTIVE COMPARATOR

Biological: 12-Valent Pneumococcal Conjugate Vaccine

12-Valent Pneumococcal Conjugate Vaccine

EXPERIMENTAL

Biological: 12-Valent Pneumococcal Conjugate Vaccine

Interventions

12-Valent Pneumococcal Conjugate Vaccine BIOLOGICAL

PCV12 group 1: 550 subjects receiving the 12-valent pneumococcal polysaccharide conjugate vaccine (12Pn-PD-DiT-CRM), defined as PCV12 in this protocol

Also known as: PCV12

12-Valent Pneumococcal Conjugate Vaccine; PCV10 (Synflorix®); PCV13 (Prevenar13®)

Eligibility Criteria

• Age: 2 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subjects, 6-12 weeks of age, inclusive, at the time of the first vaccination.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol, including:
• willing to provide name, address, and telephone number for contact if necessary (e.g., in case of missing a scheduled visit)
• available for follow-up throughout the study period
• capable to complete the forms for registration of signs and symptoms at home.
• Parent(s)/LAR(s) are able to understand and sign the informed consent form.

You may not qualify if:

• Preterm infants (gestation \<36 weeks) or with low birth weight (\<2000g).
• Use of any investigational or non-registered product other than the study vaccines and allowed co-administered vaccines as outlined in section 3.4.9. during the entire study period. Any other vaccine administration must be discussed and approved by the medical monitor.
• Medical history of culture- or PCR-confirmed invasive disease caused by S. pneumoniae.
• Coagulation problems.
• Chronic administration (more than 14 days in total) of corticosteroids, immunosuppressants or other immune-modifying drugs (except palivizumab) since birth or planned use during the study.
• Administration of immunoglobulins and/or blood products since birth or planned use during the study period.
• Participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
• Major congenital defects or serious chronic illness.
• History of any seizures or any neurological disease
• Acute disease and/or fever (axillary temperature ≥38ºC) at the time of enrolment.
• Previous vaccination with any pneumococcal vaccine.
• Infants born of woman who received any pneumococcal vaccine during pregnancy.

Sponsors & Collaborators

• Maria de Lourdes de Sousa Maia, MD: lead

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: February 10, 2023
• Study Start: August 28, 2023
• Primary Completion: April 28, 2024
• Study Completion: January 28, 2025
• Last Updated: February 10, 2023

Record last verified: 2023-01