CompletedPhase 1/2

A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older

United States669 participantsStarted 2018-07-06

Plain-language summary

The purpose of this study for: Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3. Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen. Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.

Who can participate

Age range60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Before randomization, a woman must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods * In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening * For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States (US) Food and Drug Administration (FDA) toxicity, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's s…

What they're measuring

Cohort 1: Number of Participants With Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to Day 730

Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to Day 730

Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to Day 1095

Cohort 3: Number of Participants With Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to Day 1095

Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1

Timeframe: 7 days post-vaccination 1 on Day 1 (Day 8)

Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2

Timeframe: 7 days post-vaccination 2 on Day 57 (Day 64)

Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3

Timeframe: 7 days post-vaccination 3 on Day 365 (Day 372)

Trial details

NCT IDNCT03502707

SponsorJanssen Vaccines & Prevention B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-16

Results submitted2023-08-14

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cohort 1: Number of Participants With Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to Day 730

Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to Day 730

Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to Day 1095

Cohort 3: Number of Participants With Serious Adverse Events (SAEs)

Timeframe: From Day 1 up to Day 1095

Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1

Timeframe: 7 days post-vaccination 1 on Day 1 (Day 8)

Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2

Timeframe: 7 days post-vaccination 2 on Day 57 (Day 64)

Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3

Timeframe: 7 days post-vaccination 3 on Day 365 (Day 372)