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Trial · NCT04908683

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)Group 1: Ad26.RSV.preF and RSV preF Protein44Participants
Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)Group 2: Placebo63Participants
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)Group 1: Ad26.RSV.preF and RSV preF Protein77Participants
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)Group 2: Placebo101Participants
Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second YearGroup 1: Ad26.RSV.preF and RSV preF Protein16Participants
Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second YearGroup 2: Placebo29Participants
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second YearGroup 1: Ad26.RSV.preF and RSV preF Protein39Participants
Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second YearGroup 2: Placebo44Participants
Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole StudyGroup 1: Ad26.RSV.preF and RSV preF Protein4Participants
Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole StudyGroup 2: Placebo11Participants
Number of Participants With Serious Adverse Events (SAEs)Group 1: Ad26.RSV.preF and RSV preF Protein28 days post vaccination on Day 1119Participants
Number of Participants With Serious Adverse Events (SAEs)Group 2: Placebo28 days post vaccination on Day 153Participants
Number of Participants With Serious Adverse Events (SAEs)Group 1: Ad26.RSV.preF and RSV preF ProteinFirst year follow-up446Participants
Number of Participants With Serious Adverse Events (SAEs)Group 2: PlaceboFirst year follow-up239Participants
Number of Participants With Potential Adverse Events of Special Interest (AESIs)Group 1: Ad26.RSV.preF and RSV preF Protein28 days post vaccination on Day 125Participants
Number of Participants With Potential Adverse Events of Special Interest (AESIs)Group 2: Placebo28 days post vaccination on Day 14Participants
Number of Participants With Potential Adverse Events of Special Interest (AESIs)Group 1: Ad26.RSV.preF and RSV preF ProteinFirst year follow-up71Participants
Number of Participants With Potential Adverse Events of Special Interest (AESIs)Group 2: PlaceboFirst year follow-up35Participants
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After VaccinationGroup 1: Ad26.RSV.preF and RSV preF Protein1076Participants
Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After VaccinationGroup 2: Placebo169Participants

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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