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

Safety and immunogenicity of Heptavalent Conjugate Vaccine against Pneumococcal in healthy adults. Phase I.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000133

Enrollment

Registered

2012-07-20

Start date

2012-06-17

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 infection.

Interventions

Both groups received the vaccine by intramuscular route. Study group: Single dose (0.5ml) of VCN7-T Heptavalent Pneumococcal Conjugate Vaccine. Control group: Single dose (0.5ml) PNEUMO 23 ® Polyvalen

Eligibility

Sex/Gender

Male

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged between 18 and 35 (including the limit ages) 2. General, regional and specific physical examination without any alteration. 3. Vital signs within the following limits: - Sistolic Blood Pressure < 140 mmHg - Diastolic Blood Pressure < 90 mmHg - Heart rate80 ± 20 per minute - Respiratory rate16 ± 4 per minute - Temperature< 37 0C 4. Subject with hemoglobin rate above 12.5 g/L and other laboratory findings within the range of reference values. 5. Body Mass Index (BMI) between 18.5 and 29.9 (including the limits). 6. Subjects who express their consent to participate in the study written.

Exclusion criteria

Exclusion criteria: 1. Chronic diseases such as Asthma, Chronic Obstructive Pulmonary Disease (COPD), Ischemic Heart Disease, High Blood Pressure (hypertension), Diabetes mellitus (DM), thyroid disease, Epilepsy, neuropathies or diseases of the haemolymphopoietic system. 2. Immunosuppresive diseases, either congenital or acquired. 3. Fever or acute infection within ten (10) days prior to vaccination or upon the shot. 4. Severe allergic disease or immune system diseases. 5. Renal and / or hepatic failure. 6. Hypersensitivity to thimerosal or any of the other components of the formulation. 7. Mentally handicapped 8. Convulsive encephalopathies 9. Immunostimulatory or immunosuppressive therapy, blood products or other vaccinations in a period of 2 months 10. Subject with a history of previous vaccination against Streptococcus pneumoniae 11. Alcoholism.

Design outcomes

Primary

Measure	Time frame
Adverse event (EA). Measurement time: Measurement time: 3 hours, 24 hours, 48 hours, 72 hours and 30 days after immunization • Description of EA: report of adverse event • Duration of EA: Date of beginning and end of the event reported • Intensity of EA: mild, moderate and severe • Severity of EA: serious or not serious • Results of the EA: recovered, recovered with sequelae, persistence when the subject concludes the study, death and unknown • Relationship Causality: related and unrelated.	—

Measure

Time frame

Adverse event (EA). Measurement time: Measurement time: 3 hours, 24 hours, 48 hours, 72 hours and 30 days after immunization • Description of EA: report of adverse event • Duration of EA: Date of beginning and end of the event reported • Intensity of EA: mild, moderate and severe • Severity of EA: serious or not serious • Results of the EA: recovered, recovered with sequelae, persistence when the subject concludes the study, death and unknown • Relationship Causality: related and unrelated.

—

Secondary

Measure	Time frame
Seroprotection (Concentrations of antibodies for each serotype PsC greater than or equal to 0.20 mg / mL and titles opsonophagocytic greater or equal to 1:8). Measurement time: 30 days after immunization	—

Countries

Cuba

Contacts

Public ContactBeatriz Paredes Moreno

Biomolecular Chemistry Center (CQB)

beatriz.paredes@cqb.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026