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Clinical Trials/RPCEC00000182
RPCEC00000182
Completed
Phase 2

Immunogenicity and efficacy of Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children. Phase II/III. - ISCANI

Biomolecular Chemistry Center (CQB)0 sites1,140 target enrollmentAugust 6, 2014
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ConditionsPneumococcal infection

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Pneumococcal infection
Sponsor
Biomolecular Chemistry Center (CQB)
Enrollment
1140
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 6, 2014
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Biomolecular Chemistry Center (CQB)

Eligibility Criteria

Inclusion Criteria

  • •1\. Children 2\-5 years old in the first stage and 12 to 23 months in the second, residents in municipality Cienfuegos, whose health condition, established by medical criteria, by physical examination, medical history and personal and family history.
  • •2\. Children whose parents or guardians sign the Informed Consent.
  • •3\. Nutritional assessment greater than the 3rd percentile.

Exclusion Criteria

  • •1\. Acute infectious disease at the time of application of the vaccine or within 7 days prior to administration of the vaccine. ( It may wait until 7 days after the date corresponding vaccination to apply the same to the case of the second dose).
  • •2\. Major congenital malformations diseases.
  • •3\. History of decompensated or chronic disease treatment as usual .
  • •4\. History of immunosuppressive or immunostimulatory in the 30 days prior to administration of the VCN7\-T.
  • •5\. History of severe allergic reactions or illnesses or immune system diseases.
  • •6\. Background of anaphylaxis after administration of a vaccine or as Thiomersal mercurial products.
  • •7\. Children with a history of having been immunized with a vaccine against Streptococcus pneumoniae.
  • •8\. Children with history of Febrile Seizure disease .
  • •9\. Use of any investigational product within 30 days prior to immunization.
  • •10\.History of treatment with blood as blood transfusion, plasma, whole blood or platelet concentrate at any time in their life.

Outcomes

Primary Outcomes

Not specified

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