Prospective randomized open-label comparative study of immunogenicity after subunit and polymeric subunit influenza vaccines administration among mothers and infants.

Pregnant women are risk group for influenza infection. Results of new subunit vaccines application have not been studied enough. Prospective, randomized, open-label comparative study of subunit (Agrippal) and polymeric subunit (Grippol plus) vaccines. 42 pairs of mothers-infants were participated in the study. Protective antibodies (≥ 1:40) to different influenza strains were registered on day 1 after the birth on the same level as 53% of cases in pairs mothers-infants after immune adjuvant polymeric subunit and subunit vaccines administration. There were the same level of protective antibodies (AB) among mothers after 3 month, but transplacental antibodies decreased among infants and registered in the 13-22% cases of Grippol plus group and 31-43% cases in Agrippal S1 group. AB titre to influenza virus A/H1N1/pdm09 and A/H3N2/in pairs mothers-infants were the same in both groups in first days after birth, but AB levels to B strain were lower among infants without regard to vaccine. There is no difference in AB titres among infants of both groups at 3 month of age, but their levels were twice lower versus initial data. An immune adjuvant polymeric subunit as well as subunit vaccines application in pregnant women forms protective AB in pairs mothers-infants.

RCT Entities:   Population Interventions Outcomes