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Clinical Trials/RPCEC00000432
RPCEC00000432
Not yet recruiting
Phase 3

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

Finlay Vaccine Institute (FVI)0 sitesOctober 4, 2023
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ConditionsPneumococcal diseasesVCN7-TPneumococcal InfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial Infections

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Pneumococcal diseases
Sponsor
Finlay Vaccine Institute (FVI)
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 4, 2023
End Date
March 11, 2027
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Finlay Vaccine Institute (FVI)

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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