Low dose RSV-F Vaccine with Adjuvant; Seasonal TIV

Percentages of infants with medically-significant RSV LRTI from delivery through 90, 120,150, and 180 days of life, as defined by: * The presence of RSV infection confirmed by detection of RSV genome by RT-PCR on respiratory secretions (obtained within the continuous illness episode which fulfills the other criteria listed below); AND * At least one manifestation of lower respiratory tract infection (LRTI) from among the following: cough, nasal flaring, lower chest wall indrawing, subcostal retractions, stridor, rales, rhonchi, wheezing, crackles/crepitations, or observed apnea; AND * Evidence of medical significance as defined by the presence of: * EITHER hypoxemia (peripheral oxygen saturation \[SpO2\] \< 95% at sea level or \< 92% at altitudes \> 1800 meters) OR * Tachypnea (≥ 70 breaths per minute \[bpm\] in infants 0 to 59 days of age and ≥ 60 bpm in infants ≥ 60 days of age).

Defined by the presence of at least three (3) of: cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, and observed tachypnea (≥20 breaths per minute); plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.

Defined as solicited local and systemic AEs over the 7 days post-injection; all adverse events, solicited and unsolicited over 56 days after dosing; and MAEs, SAEs, and SNMCs over one year post dosing.

Derived/calculated endpoints based on these data will include: * Geometric mean concentration as EU (GMEU) * Geometric mean ratio (GMR) * Seroresponse rate (SRR) * Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)

Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/ calculated endpoints based on these data will include: * Geometric mean concentrations as EU (GMEU) * Geometric mean ratio (GMR) * Geometric mean fold-rise( GMFR) * Seroresponse rate (SRR)

Defined by any one of rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or increase in baseline wheezing), sputum production (or increase in the change in nature of baseline sputum production), or new (or worsening) shortness of breath; plus RT-PRC-confirmed RSV infection documented within three days of symptom onset.

Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters over 56 days post injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.

In Maternal Subjects

In Maternal Subjects

In Maternal Subjects

In Maternal Subjects

In Infant subjects

In Infant Subjects

In Infant Subjects

In Infant Subjects

In Infant Subjects

Immunogenicity will be measured using derived / calculated endpoints based on: * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)

Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post-injections; all adverse events, solicited and unsolicited over 56 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for six months

Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroresponse rate (SRR)

Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post injection; all adverse events, solicited and unsolicited over 56 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year.

Immunogenicity will be measured using derived / calculated endpoints based on: * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)