Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin.

Introduction: The biosimilar SAR341402 insulin aspart (SAR-Asp) was compared to its originator NovoLog®/NovoRapid® insulin aspart (NN-Asp) in terms of efficacy, safety, and immunogenicity, in adults with type 1 or type 2 diabetes switching from different rapid-acting insulin analogs.

Methods: This phase 3, randomized, open-label, multinational, 52-week study (GEMELLI 1) enrolled participants with type 1 or type 2 diabetes (n = 597). At randomization, participants transitioned from NovoLog/NovoRapid (n = 380) or Humalog®/Liprolog® (n = 217) to equivalent (1:1) doses (or a dose at the discretion of the investigator) of either SAR-Asp or NN-Asp (1:1 randomization).

Safety, Immunogenicity, and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial.

SAR341402 (SAR-Asp) is a biosimilar/follow-on of the originator insulin aspart-NovoLog/NovoRapid (NN-Asp). This study investigated whether the efficacy, safety, and immunogenicity findings for SAR-Asp versus NN-Asp, observed over 6 months in people with type 1 ( = 497) or type 2 diabetes ( = 100) treated with multiple daily injections in combination with insulin glargine (Lantus), are maintained after 12 months. GEMELLI 1 was a multicenter, randomized, open-label, phase 3 study.

Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1).

This study compared the efficacy, safety, and immunogenicity of insulin aspart biosimilar/follow-on biologic product SAR341402 (SAR-Asp) with originator insulin aspart-NovoLog/NovoRapid (NN-Asp) in people with type 1 diabetes (T1D) or type 2 diabetes (T2D) treated with multiple daily injections in combination with insulin glargine (Lantus; Gla-100). This 6-month, randomized, open-label, phase 3 study (NCT03211858) enrolled 597 people with T1D ( = 497) or T2D ( = 100). Participants were randomized 1:1 to mealtime SAR-Asp ( = 301) or NN-Asp ( = 296) in combination with Gla-100.

Immunogenicity of 10-valent pneumococcal nontypeable Haemophilus Influenzae Protein D Conjugate Vaccine when administered as catch-up vaccination to children 7 months to 5 years of age.

Background: We evaluated catch-up vaccination schedules with 10-valent pneumococcal nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV).

Methods: In this open, controlled study, children stratified into 4 age groups (N = 150 each) were vaccinated with PHiD-CV: (a) <6 months reference group: 3 primary doses with booster at 12 to 15 months, (b) 7 to 11 months: 2 doses and booster at 12 to 15 months, (c) 12 to 23 months: 2 doses, and (d) 2 to 5 years: 1 dose. Serotype-specific pneumococcal responses were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic activity (OPA) assay.

Maternal antibodies in breast milk protect the child from enterovirus infections.

Objective: Enterovirus infections are frequent in infants and may cause severe complications. We set out to assess whether breastfeeding can protect against these infections and whether such an effect is related to maternal antibodies in breast milk or in the peripheral circulation of the infant.

Methods: One hundred fifty infants who were prospectively followed up from birth were monitored for enterovirus infections.