The phase 3, randomized, two-arm, parallel group, double-blind, active controlled non-inferiority clinical trial evaluating the 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

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.

Target sample size: 324