Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children.

• Register: RPCEC
• Last refreshed on: 1 April 2024
• Main ID: RPCEC00000182
• Date of registration: 06/08/2014
• Prospective Registration: No
• Primary sponsor: Biomolecular Chemistry Center (CQB)
• Public title: Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children.
• Scientific title: Immunogenicity and efficacy of Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children. Phase II/III. - ISCANI
• Date of first enrolment: 09/06/2014
• Target sample size: 1140
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000182-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Prevention
• Phase: 2-3

Countries of recruitment

Cuba

Contacts

• Name: Nadezhda Gonzalez Garcia
• Affiliation: Biomolecular Chemistry Center (CQB)

• Name: Nadezhda Gonzalez Garcia
• Affiliation: Biomolecular Chemistry Center (CQB)

Key inclusion & exclusion 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.
11. Children with a history of having been immunized with any vaccine in the vaccination scheme Cuban 30 days prior to the administration of the vaccine.

Age minimum: 1st Stage: 2 years, 2nd Stage: 12 months
Age maximum: 1st Stage: 5 years, 2nd Stage: 23 months
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Pneumococcal infection

Intervention(s)

First Stage: Children 2 to 5 years.
Study Group (Heptavalent Pneumococcal Conjugate Vaccine (VCN7-T)): 1 dose of VCN7-T, intramuscularly in the deltoid.
Control Group (Pneumococcal 10-valent protein D conjugate Haemophilus influenzae nontypable, Synflorix ®, GlaxoSmithKline): 1 dose of Synflorix, intramuscularly in the left deltoid.

Second stage: Children 12 to 23 months.
Study Group (Heptavalent Pneumococcal Conjugate Vaccine (VCN7-T)): 2 doses of VCN7-T with interval of 8 weeks intramuscularly in the deltoid.
Control Group (Pneumococcal 10-valent protein D conjugate Haemophilus influenzae nontypable, Synflorix ®, GlaxoSmithKline): 2 doses of Synflorix with interval of 8 weeks intramuscularly in the deltoid.

Primary Outcome(s)

- Geometric mean concentration of anti-PsC antibodies for each serotype included in VCN7-T and additional serotypes 6A and 19A (continuous). Measurement time: First stage: Before and 30 days post-vaccination, Second Stage: Before the first dose and 30 days after the second dose.
- Seroprotection (dichotomous): Proportion of subjects reaching anti-PsC concentration of antibodies for each serotype included in VCN7-T and additional serotypes 6A and 19A of = 0.20 mg / mL. Measurement time: First stage: Before and 30 days post-vaccination, Second Stage: Before the first dose and 30 days after the second dose.
- Seroconversion (dichotomous): proportion of subjects who seroconverted. Measurement time: First stage: Before and 30 days post-vaccination, Second Stage: Before the first dose and 30 days after the second dose.

Secondary Outcome(s)

Adverse event (AE). Measuring time: 3 hours after each immunization and at 24, 48, 72 hours, 7, 21 and 30 days.
-Description of the expected AE (Fever, pain injection site, erythema, induration, local temperature increase, functional impotence, infiltration, abscess, necrosis, headache, malaise, nausea, vomiting, weakness, anaphylactic shock.
-Description of the unexpected AE (Any signs or symptoms that appear after the before vaccination and 30 days is not expected within the AE.
-Duration of AE (<= 24 hours> 24 - <= 48 hours> 48 - <= 72 hours, more than 72 hours).
-Emergence of AE (<= 24 hours> 24 - <= 48 hours> 48 - <= 72 hours, more than 72 hours).
-Intensity of AE (mild, moderate, severe).
-Severity of AE (Grave / Serious, not serious).
-Results of AE (recovered, recovered with sequelae, persistence, death or unknowns).
-Causality relationship (very likely or certain, probable, possible, unlikely, not related, not classifiable).

Secondary ID(s)

CQB/NEU/14/EC-II-III/03

Source(s) of Monetary Support

Biomolecular Chemistry Center (CQB)

Secondary Sponsor(s)

Finlay Institute