Evaluation of immunogenicity and safety of the 13-valent pneumococcal vaccine (PneumoConj®- manufactured by Nivad Pharmed Salamat), compared to the 13-valent pneumococcal vaccine (Prevnar®- manufactured by Pfizer) as the reference product, in infants aged 8 ± 2 weeks

Phase 3

Recruiting

Conditions: Otitis media prevention / Pneumonia prevention.
Pneumonia due to Streptococcus pneumoniae

Registration Number: IRCT20240626062259N1

Lead Sponsor: ivadPharmed Salamat company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 324

Inclusion Criteria

Infants aged 8±2 weeks.
Good general health (confirmed through clinical examinations and medical records, e.g., normal growth curve, normal head circumference).
Parents willing to provide informed and voluntary written consent for their infant's participation in the study.
Ability to accompany their infant for study visits and follow-up sessions.

Exclusion Criteria

History of previous vaccination against pneumococcal strains.
History of severe hypersensitivity reactions following vaccine injection.
Infants with congenital abnormalities, growth disorders, genetic defects, or severe malnutrition.
Infants with pathological jaundice lasting 2 to 4 weeks and recurring.
History of confirmed respiratory infection at clinic or serology, especially due to Streptococcus pneumoniae.
History of HIV infection in mother or infant.
Presence of thrombocytopenia (platelets less than 150,000) or other coagulation disorders.
Axillary temperature above 37.8 degrees Celsius within 72 hours prior to the study.
Family history of seizures, epilepsy, or encephalopathy in first-degree relatives of the infant.
Preterm and low birth weight infants (born before 37 weeks of gestation with birth weight less than 2.5 kilograms).
Family history of congenital or hereditary immunodeficiency in first-degree relatives.
Receipt of vaccines outside of the national immunization schedule or medications prohibited simultaneously.
Conditions deemed by the principal investigator to prevent participation.
Participation in other clinical vaccine studies.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IgG seroresponse rate against different serotypes after 5 months: IgG seroresponse rate against different serotypes after 5 months (one month after the third dose injection) compared to the control group. Timepoint: One month after the third dose injection. Method of measurement: ELISA. Percentage of individuals with IgG antibody concentration above 0.35 micrograms per milliliter.;IgG GMC ratio against different serotypes after 5 months: IgG GMC ratio against different serotypes after 5 months (one month after the third dose injection) in the candidate group compared to the control group. Timepoint: One month after the third dose injection. Method of measurement: ELISA.

Secondary Outcome Measures