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IRCT20240626062259N1 IRCT 2024-07-30 NivadPharmed Salamat company 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 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 2024-07-31 anticipated 324 Complete https://irct.ir/trial/77675 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Allocation of infants to intervention groups is done by stratified randomization by www.sealedenvelope.com. The strata in this study are the centers and, in each stratum, random numerical sequences will be created in the form of permuted blocks. For this purpose, random blocks with block size 2 and 4 (equal number of each group are present in each block) and with a ratio of 1:1 will be done for a total of 324 infants. When randomization is done, each infant will receive a unique code by which he will be identified throughout the study, Blinding description: Given that the control and test drug packages are completely identical and are identified using random codes, the parents of the participants will not be aware of the type of vaccine their child has received. Additionally, study data will be anonymized based on the unique identification codes assigned to each participant at the start of the study. This ensures that the study remains blinded for both the doctor and the evaluator. Similarly, the samples and laboratory results will be identified and reported only with the codes corresponding to each participant, without any names. 3 Otitis media prevention / Pneumonia prevention. Intervention 1: Intervention group: PneumoConj®- manufactured by Nivad Pharmed Salamat The pre-filled syringe of 13-valent pneumococcal vaccine (PneumoConj®- manufactured by Nivad Pharmed Salamat), administered intramuscularly (right thigh muscle) at a dose of 0.5 milliliters at 2, 4, and 6 months of age in infants, with a booster dose administered at 12 to 15 months of age. Intervention 2: Control group: Prevnar®- manufactured by Pfizer The pre-filled syringe of 13-valent pneumococcal vaccine (Prevnar®- manufactured by Pfizer), administered intramuscularly (right thigh muscle) at a dose of 0.5 milliliters at 2, 4, and 6 months of age in infants, with a booster dose administered at 12 to 15 months of age. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Hamidreza Kafi
No 42. Attar sq, Attar st, Valiasr st, Vanak sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 kafi.h@orchidpharmed.com Orchid Pharmed Co. scientific Dr. Hamidreza Kafi
No 42. Attar sq, Attar st, Valiasr st, Vanak sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 kafi.h@orchidpharmed.com Orchid Pharmed Co. Iran (Islamic Republic of) 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. 42 days 70 days Both 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. J13 Pneumonia due to Streptococcus pneumoniae Prevention Prevention Intervention group: PneumoConj®- manufactured by Nivad Pharmed Salamat The pre-filled syringe of 13-valent pneumococcal vaccine (PneumoConj®- manufactured by Nivad Pharmed Salamat), administered intramuscularly (right thigh muscle) at a dose of 0.5 milliliters at 2, 4, and 6 months of age in infants, with a booster dose administered at 12 to 15 months of age Control group: Prevnar®- manufactured by Pfizer The pre-filled syringe of 13-valent pneumococcal vaccine (Prevnar®- manufactured by Pfizer), administered intramuscularly (right thigh muscle) at a dose of 0.5 milliliters at 2, 4, and 6 months of age in infants, with a booster dose administered at 12 to 15 months of age 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. 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 assessment. Number of individuals experiencing Solicited Adverse Drug Reactions in the first 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. Timepoint: First 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. Method of measurement: Clinical assessment. Number of individuals experiencing Systematic Adverse Drug Reactions in the first 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. Timepoint: First 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. Method of measurement: Clinical assessment. Number of individuals experiencing Unsolicited Adverse Drug Reactions in the first 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. Timepoint: First 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. Method of measurement: Clinical assessment. Number of individuals experiencing Adverse Events of Special Interest (AESIs) in the first 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. AESIs include shoulder injury related to vaccine administration and vasovagal syncope. Timepoint: First 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. Method of measurement: Clinical assessment. Number of individuals experiencing Medically Attended Adverse Events (MAEs) in the first 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. MAEs include undesirable events demanding medical attendance that are not part of routine medical examination or vaccination visits, such as hospitalizations, emergency department visit, or any unscheduled medical visits for any reason. Timepoint: First 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. Method of measurement: Clinical assessment. Number of individuals experiencing Severe Adverse Events (SAEs) in the first 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. SAEs refer to any adverse event resulting in death, life-threatening situations, need for hospitalization or prolongation of hospitalization, disability or congenital anomaly, and significant impairment of the participant under investigation. Timepoint: First 7 days following each injection (Day 0-7), and then weekly until 1 month after the third dose injection and 1 month after the booster dose injection. Method of measurement: Clinical assessment. NivadPharmed Salamat company Approved 2024-04-16 Research Ethics Committee / Ministry-level Research Ethics Working Group 13th Floor, Block A, Central Headquarters, Ministry of Health and Medical Education, Simaye Iran Street, between South Flamak and Zarafshan, Shahrak-e Ghods (West), Tehran, Iran Tehran Tehran Iran (Islamic Republic of)