Phase III study of the Cuban vaccine candidate VCN7-T in patients from 1 to 18 years of age at risk of pneumococcal disease in Havana

Evaluation of the safety, immunogenicity and clinical effectiveness of the application of the Cuban anti-pneumococcal vaccine candidate PCV7-T, in patients from one to 18 years of age at risk of pneumococcal disease in the province of Havana. Phase III - NRH/24

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000432

Enrollment

Unknown

Registered

2023-10-04

Start date

2023-10-09

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal diseases VCN7-T

Interventions

Patients from 1 to 18 years of age, belonging to risk groups for pneumococcal disease in the province of Havana. Experimental group (VCNT-7): The Heptavalent Conjugate Vaccine against Pneumococci (VC

In America they represent more than 70% of the isolated serotypes. Children from 12 months to 23 months of age: Two doses will be administered, in a volume of 0.5 mL, by intramuscular route (deltoid),

Heptavalent Pneumococcal Conjugate Vaccine

Pneumococcal Vaccines

Injections, Intramuscular

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients from 1 to 18 years of age, of any sex, from the province of Havana, identified in risk groups for pneumococcal disease. 2. Informed consent of parents and assent of adolescents for vaccination and follow-up.

Exclusion criteria

Exclusion criteria: 1. Previous pneumococcal vaccination. 2. Children with a reported allergy to thiomersal or any biological product or vaccines causing a serious adverse reaction of the anaphylaxis type. 3. Decompensation of the underlying disease at the time of evaluation. 4. Subjects with febrile or acute infectious illness at the time of application of the vaccine candidate, or in the previous 7 days. 5. Subjects vaccinated according to the Cuban immunization schedule, in a period of less than 15 days prior to the application of the investigational product. 6. Adolescents who are pregnant or have amenorrhea greater than 4 weeks before the application of the vaccine candidate.

Design outcomes

Primary

Measure	Time frame
Proportion of adverse events attributable to vaccination with VCN7-T, 30 days after vaccination.	—

Secondary

Measure	Time frame
1. Cumulative incidence of pneumonia and IPD cases. 2. Percentage of subjects in the studied subgroup, with an immune response to the vaccine serotypes.	—

Countries

Cuba

Contacts

Public ContactNarciso Jimenez Perez

Finlay Vaccine Institute (FVI)

njimenez@finlay.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026