Created at Source Raw Value Validated value
Jan. 5, 2025, 10:16 p.m. usa

Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection;GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection;Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1;Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2;Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period;Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1;Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2;Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period

Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection;GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection;Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1;Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2;Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period;Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1;Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2;Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period

May 20, 2022, 9 a.m. usa

Describe the immune response in pregnant women and reference to the immune response in nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection;Describe the immune response in pregnant women and reference to the immune response to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting: Local reactions;Percentage of maternal participants reporting serious adverse events;Percentage of maternal participants reporting systemic events

Describe the immune response in pregnant women and reference to the immune response in nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection;Describe the immune response in pregnant women and reference to the immune response to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting: Local reactions;Percentage of maternal participants reporting serious adverse events;Percentage of maternal participants reporting systemic events

June 23, 2021, 1:30 a.m. usa

Demonstrate immunobridging of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection;Demonstrate immunobridging of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting: Local reactions;Percentage of maternal participants reporting serious adverse events;Percentage of maternal participants reporting systemic events

Demonstrate immunobridging of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection;Demonstrate immunobridging of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting: Local reactions;Percentage of maternal participants reporting serious adverse events;Percentage of maternal participants reporting systemic events

April 16, 2021, 12:31 a.m. usa

Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection;Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Percentage of maternal participants (approx first 600 randomized participants) reporting adverse events;Percentage of maternal participants (approx first 600 randomized participants) reporting Local reactions;Percentage of maternal participants (approx first 600 randomized participants) reporting serious adverse events;Percentage of maternal participants (approx first 600 randomized participants) reporting systemic events;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting: Local reactions;Percentage of maternal participants reporting serious adverse events;Percentage of maternal participants reporting systemic events

Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection;Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Percentage of maternal participants (approx first 600 randomized participants) reporting adverse events;Percentage of maternal participants (approx first 600 randomized participants) reporting Local reactions;Percentage of maternal participants (approx first 600 randomized participants) reporting serious adverse events;Percentage of maternal participants (approx first 600 randomized participants) reporting systemic events;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting: Local reactions;Percentage of maternal participants reporting serious adverse events;Percentage of maternal participants reporting systemic events

Feb. 17, 2021, 12:31 a.m. usa

Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection;Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting: Local reactions;Percentage of maternal participants reporting serious adverse events;Percentage of maternal participants reporting systemic events

Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection;Demonstrate non inferiority of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting: Local reactions;Percentage of maternal participants reporting serious adverse events;Percentage of maternal participants reporting systemic events