Journal: eClinicalMedicine

Article Title: Safety and immunogenicity of bivalent RSVpreF vaccine formulated in a multidose vial in healthy female participants in the USA: a multicentre, randomised, open-label, noninferiority phase 3 study

doi: 10.1016/j.eclinm.2026.103767

Figure Lengend Snippet: Participant dispositions and analysis populations . a One participant did not complete the 1-month postvaccination visit but completed the end-of-study telephone call. b The end-of-study telephone call was scheduled to take place 42–49 days after vaccination. c Participants could be excluded for more than one reason. MDV = multidose vial; RSVpreF = respiratory syncytial virus prefusion F protein vaccine; SDV = single-dose vial.

Article Snippet: Multiple phase 3 clinical trials have demonstrated safety, immunogenicity, and efficacy of the bivalent RSV prefusion F protein unadjuvanted vaccine (RSVpreF; Abrysvo®; Pfizer Inc, New York, NY, USA), leading to US approval in 2023. , , , , In the placebo-controlled phase 3 Maternal Immunization Study for Safety and Efficacy (MATISSE), efficacy rates of RSVpreF vaccination against severe RSV-associated medically attended lower respiratory tract illness among infants born to pregnant women who received 120 μg RSVpreF at 24–36 weeks’ gestation were 82·4% and 70·0% within 90 and 180 days after birth, respectively.

Techniques: Virus

Journal: eClinicalMedicine

Article Title: Safety and immunogenicity of bivalent RSVpreF vaccine formulated in a multidose vial in healthy female participants in the USA: a multicentre, randomised, open-label, noninferiority phase 3 study

doi: 10.1016/j.eclinm.2026.103767

Figure Lengend Snippet: (a) RSV neutralising GMRs of the RSVpreF MDV group to the RSVpreF SDV group at 1 month after vaccination and corresponding GMTs and GMFRs from baseline for (b) RSV A and (c) RSV B . Data are for the evaluable immunogenicity population. Error bars represent 95% CIs. Dotted line indicates prespecified noninferiority acceptance criteria for the lower limit of the 95% CIs. If the titre before vaccination was

Article Snippet: Multiple phase 3 clinical trials have demonstrated safety, immunogenicity, and efficacy of the bivalent RSV prefusion F protein unadjuvanted vaccine (RSVpreF; Abrysvo®; Pfizer Inc, New York, NY, USA), leading to US approval in 2023. , , , , In the placebo-controlled phase 3 Maternal Immunization Study for Safety and Efficacy (MATISSE), efficacy rates of RSVpreF vaccination against severe RSV-associated medically attended lower respiratory tract illness among infants born to pregnant women who received 120 μg RSVpreF at 24–36 weeks’ gestation were 82·4% and 70·0% within 90 and 180 days after birth, respectively.

Techniques: Immunopeptidomics, Transformation Assay, Quantitation Assay, Virus

Journal: eClinicalMedicine

Article Title: Safety and immunogenicity of bivalent RSVpreF vaccine formulated in a multidose vial in healthy female participants in the USA: a multicentre, randomised, open-label, noninferiority phase 3 study

doi: 10.1016/j.eclinm.2026.103767

Figure Lengend Snippet: Rates of (a) local reactions and (b) systemic events reported within 7 days after vaccination . Data are for the safety population. Error bars represent 95% CIs, which were calculated using the Clopper-Pearson method. The number of participants included in each group was as follows: RSVpreF MDV, n = 223; RSVpreF SDV, n = 227. Grading scales are provided in . MDV = multidose vial; RSVpreF = respiratory syncytial virus prefusion F protein vaccine; SDV = single-dose vial.

Article Snippet: Multiple phase 3 clinical trials have demonstrated safety, immunogenicity, and efficacy of the bivalent RSV prefusion F protein unadjuvanted vaccine (RSVpreF; Abrysvo®; Pfizer Inc, New York, NY, USA), leading to US approval in 2023. , , , , In the placebo-controlled phase 3 Maternal Immunization Study for Safety and Efficacy (MATISSE), efficacy rates of RSVpreF vaccination against severe RSV-associated medically attended lower respiratory tract illness among infants born to pregnant women who received 120 μg RSVpreF at 24–36 weeks’ gestation were 82·4% and 70·0% within 90 and 180 days after birth, respectively.

Techniques: Virus