Otitis media prevention / Pneumonia prevention. Pneumonia due to Streptococcus pneumoniae
Conditions
Interventions
Intervention 1: Intervention group: PneumoConj®- manufactured by Nivad Pharmed Salamat The pre-filled syringe of 13-valent pneumococcal vaccine (PneumoConj®- manufactured by Niva
Sponsors
NivadPharmed Salamat company
Eligibility
Sex/Gender
All
Age
42 Days to 70 Days
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| IgG seroresponse rate against different serotypes after the booster dose: IgG seroresponse rate against different serotypes after the booster dose compared to the control group. Timepoint: One month after the booster 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 the booster dose: IgG GMC ratio against different serotypes after the booster dose in the candidate group compared to the control group. Timepoint: One month after the booster dose injection. Method of measurement: ELISA.;OPA seroresponse rate against different serotypes after 5 months and after the booster dose: OPA seroresponse rate against different serotypes after 5 months (one month after the third dose injection) and after the booster dose in the candidate group compared to the control group (in a subset of subjects). Timepoint: One month after the third dose injection and one month after the booster dose injection. Method of measurement: OPA. Percentage of individuals with functional antibody titer above 1:8.;OPA GMC ratio against different serotypes after 5 months and after the booster dose: OPA GMC ratio against different serotypes after 5 months (one month after the third dose injection) and after the booster dose in the candidate group compared to the control group (in a subset of subjects). Timepoint: One month after the third dose injection and one month after the booster dose injection. Method of measurement: OPA.;Incidence of otitis media and pneumonia: Incidence of otitis media and pneumonia (specifying severity and pneumococcal strain type). Timepoint: Throughout the study. Method of measurement: Clinical examination and PCR.;Number of individuals experiencing Immediate Adverse Drug Reactions within the first half-hour after each injection (Day 0). Timepoint: In the first half-hour following each injection. (Day 0). Method of measurement: Clinical as | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hamidreza Kafi
Orchid Pharmed Co.
Outcome results
None listed