Respiratory Syncytial VirusPhase 1/2NCT03606512
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age
A Phase 1/2 study testing Ad26.RSV.preF and Nimenrix in people with Respiratory Syncytial Virus, run by Janssen Vaccines & Prevention B.V. at 25 sites in 8 countries.
Trial summary
The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5*10^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- Ad26.RSV.preF and Nimenrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 25 sitesin 8 countries
- Study dates
- 21 Jan 2019to 2 Nov 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant who is seronegative for respiratory syncytial virus (RSV) within 42 days prior to dosing
- Participant is the product of a normal term pregnancy greater than or equal to (>=)37 weeks, with a minimum birth weight of 2.5 kilogram (kg)
- Participant must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening
- Participant has received all routine immunizations appropriate for his or her age according to local guidelines
- Each participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer
Who cannot join
- Participant's weight is below tenth percentile according to World Health Organization (WHO) pediatric growth and weight charts
- Participant has any clinically significant acute or chronic medical condition (for example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, systemic infections, congenital heart disease, history of any pulmonary condition requiring medication, atopy, reactive airway disease, medically-confirmed wheezing, bronchoconstriction or treatment with a beta 2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness) that, in the opinion of the investigator, would preclude participation
- Participant is in receipt of, or planning to receive, live attenuated vaccine (for example, measles, mumps and rubella [MMR] or varicella, but excluding rotavirus vaccine) within 28 days of each study vaccination (that is, before and after); other vaccines (for example, influenza, pertussis, polio or rotavirus) should be given at least 14 days before or 14 days after each study vaccination
- Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
- Participant has a known allergy to vaccines or vaccine components (including any of the constituents of the study vaccine), or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine). Participants with egg allergies can be enrolled
Trial locations and contacts
25 sites in 8 countries.
25 sites in 8 countries
Brazil4 sites
Complexo Hospital de Clinicas - UFPR
Curitiba, 80030-110
Hospital Pequeno Principe
Curitiba, 80250-060
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90035-074
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000
Canada4 sites
Dalhousie University
Halifax, Nova Scotia, B3K 6R8
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
McGill University Health Centre - Vaccine Study Centre
Pierrefonds, Quebec, H9H 4Y6
CHU de Quebec Universite Laval
Québec, Quebec, G1V 4G2
Spain4 sites
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp. Univ. La Paz
Madrid, 28046
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
Australia3 sites
Barwon Health
Geelong, 3220
Telethon Kids Institute
Nedlands, 6009
Murdoch Children's Research Institute
Parkville, 3052
Finland3 sites
Järvenpään rokotetutkimusklinikka
Jarvenpaa, 04400
Tampereen rokotetutkimusklinikka
Tampere, 33100
Turun rokotetutkimusklinikka
Turku, 20520
United Kingdom3 sites
Imperial College London
London, W21PG
Royal Manchester Children's Hospital
Manchester, M13 9WL
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD
Poland2 sites
Jerzy Brzostek Prywatny Gabinet Lekarski
Dębica, 39-200
Szpital im Swietej Jadwigi Slaskiej Oddzial Pediatryczny z Pododdzialem Niemowlecym
Trzebnica, 55 100
Sweden2 sites
Sachsska barn-och ungdomssjukhuset
Stockholm, 11861
Norrlands Universitetssjukhus
Umeå, 90185
About this study
Official title: A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5*10^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.
Read the detailed description
RSV is considered the most important cause of serious acute respiratory illness in children under 5 years of age. Ad26.RSV.preF (JNJ-64400141) investigational vaccine is a replication-incompetent serotype 26 adenoviral vector (Ad26) containing a deoxyribonucleic acid (DNA) transgene that encodes for the F protein derived from the respiratory syncytial virus (RSV) A2 strain stabilized in the pre-fusion conformation (Ad26.RSV.preF). The study will evaluate whether Ad26.RSV.preF is safe, well-tolerated, and immunogenic in RSV-seronegative toddlers. The study will have 3 phases: a screening phase (up to 6 weeks before the first dose), a vaccination phase (34 weeks), and a safety follow-up phase through 2 RSV seasons after the first dose. RSV infection will be monitored by active and passive surveillance. The total duration of the study will be approximately 26 months.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- Ad26.RSV.preF, Placebo, Nimenrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ad26.RSV.preFBiological
Also called JNJ-64400141
Ad26.RSV.preF will be administered as IM injection at a dose of 2.5*10^10 vp.
PlaceboBiological
Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.
NimenrixBiological
Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: RSV Seronegative Toddlers (Ad26.RSV.preF) | Experimental | Respiratory syncytial virus (RSV) seronegative toddlers will receive intramuscular (IM) injection of 2.5*10^10 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F-protein on Days 1, 29, and 57. Receives: Biological: Ad26.RSV.preF |
| Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix) | Placebo comparator | RSV seronegative toddlers will receive IM injection of placebo on Days 1, 29 and 57. Placebo can be replaced with Nimenrix on Day 57 in countries where applicable. Receives: Biological: Placebo; Biological: Nimenrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Measured: Up to Day 8 (7 days after first vaccination on Day 1)
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Measured: Up to Day 36 (7 days after second vaccination on Day 29)
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Measured: Up to Day 64 (7 days after third vaccination on Day 57)
Number of Participants With Unsolicited AEs for 28 Days After First Vaccination
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Measured: Up to Day 29 (28 days after first vaccination on Day 1)
Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Measured: Up to Day 57 (28 days after second vaccination on Day 29)
Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Measured: Up to Day 85 (28 days after third vaccination on Day 57)
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a suspected transmission of any infectious agent via a medicinal product, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Up to 2 year 10 months
Secondary outcomes (5)
Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain
Neutralizing antibody titers assessed by virus neutralizing antibodies (VNA) against the RSV A2 strain were expressed as 50% inhibitory concentration (IC50) units.
Measured: Days 1, 8, 85, and 267 (End of first RSV season)
Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Pre-fusion A IgG serum antibody response was assessed by ELISA.
Measured: Days 1, 8, 85, and 267 (End of first RSV season)
Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA
Post-fusion A IgG serum antibody response as assessed by ELISA was reported.
Measured: Days 1, 8, 85, and 267 (End of first RSV season)
T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry
T-cell response (%) to RSV F peptides for T-helper Th1 and Th2 subtyping as measured by flow cytometry was planned to be assessed. Th1(% of Clusters of differentiation 4 [CD4]+ interferon gamma [IFN-g]+T cells; lower limit(s) of quantification [LLOQ]=0.05%) and Th2 (% of CD4+ interleukin [IL]-4+/IL-13+ and CD40L+T cells; LLOQ=0.07%) responses were determined by intracellular cytokines after RSV F peptide stimulation.
Measured: Baseline (Day 1) and Day 85
Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI)
Number of participants with severe RSV-LRTI were reported.
Measured: Up to 2 year 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start21 Jan 2019
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606512
- Sponsor's protocol ID
- CR108465
- Other IDs
- 2017-003859-36, VAC18194RSV2002, 2017
- Status last verified
- Jan 2025
- First submitted
- 20 Jun 2018
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Langley JM, Nolan TM, Ramet M, Richmond PC, Rosario Filho N, Haazen W, van den Berg SPH, Williams K, Bastian AR, Omoruyi E, Williams Durkin J, Salisch N, Van Geet G, van Duijnhoven W, Heijnen E, Callendret B. A Phase 1/2a Study Evaluating Safety and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers Aged 12-24 Months. Open Forum Infect Dis. 2024 Aug 8;11(9):ofae453. doi: 10.1093/ofid/ofae453. eCollection 2024 Sep.
PubMed 39220658
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
- ClinicalTrials.gov ID
- NCT03606512
- Acronym / sponsor ID
- CR108465
- Conditions
- Respiratory Syncytial Virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5*10^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.
Detailed description
RSV is considered the most important cause of serious acute respiratory illness in children under 5 years of age. Ad26.RSV.preF (JNJ-64400141) investigational vaccine is a replication-incompetent serotype 26 adenoviral vector (Ad26) containing a deoxyribonucleic acid (DNA) transgene that encodes for the F protein derived from the respiratory syncytial virus (RSV) A2 strain stabilized in the pre-fusion conformation (Ad26.RSV.preF). The study will evaluate whether Ad26.RSV.preF is safe, well-tolerated, and immunogenic in RSV-seronegative toddlers. The study will have 3 phases: a screening phase (up to 6 weeks before the first dose), a vaccination phase (34 weeks), and a safety follow-up phase through 2 RSV seasons after the first dose. RSV infection will be monitored by active and passive surveillance. The total duration of the study will be approximately 26 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: RSV Seronegative Toddlers (Ad26.RSV.preF) | Experimental | Biological: Ad26.RSV.preFRespiratory syncytial virus (RSV) seronegative toddlers will receive intramuscular (IM) injection of 2.5*10^10 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F-protein on Days 1, 29, and 57. |
| Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix) | Placebo comparator | Biological: Placebo, Biological: NimenrixRSV seronegative toddlers will receive IM injection of placebo on Days 1, 29 and 57. Placebo can be replaced with Nimenrix on Day 57 in countries where applicable. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participant who is seronegative for respiratory syncytial virus (RSV) within 42 days prior to dosing
- Participant is the product of a normal term pregnancy greater than or equal to (>=)37 weeks, with a minimum birth weight of 2.5 kilogram (kg)
- Participant must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening
- Participant has received all routine immunizations appropriate for his or her age according to local guidelines
- Each participant's parent(s)/legal guardian(s) must have access to a consistent means of contact either by telephone contact or email/computer
Key exclusion criteria (5 listed)
- Participant's weight is below tenth percentile according to World Health Organization (WHO) pediatric growth and weight charts
- Participant has any clinically significant acute or chronic medical condition (for example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, systemic infections, congenital heart disease, history of any pulmonary condition requiring medication, atopy, reactive airway disease, medically-confirmed wheezing, bronchoconstriction or treatment with a beta 2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness) that, in the opinion of the investigator, would preclude participation
- Participant is in receipt of, or planning to receive, live attenuated vaccine (for example, measles, mumps and rubella [MMR] or varicella, but excluding rotavirus vaccine) within 28 days of each study vaccination (that is, before and after); other vaccines (for example, influenza, pertussis, polio or rotavirus) should be given at least 14 days before or 14 days after each study vaccination
- Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
- Participant has a known allergy to vaccines or vaccine components (including any of the constituents of the study vaccine), or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine). Participants with egg allergies can be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ad26.RSV.preFAlso: JNJ-64400141Ad26.RSV.preF will be administered as IM injection at a dose of 2.5*10^10 vp. | Biological | Group 1: RSV Seronegative Toddlers (Ad26.RSV.preF) |
| PlaceboPlacebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection. | Biological | Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix) |
| NimenrixNimenrix will be administered as 0.5 milliliter (mL) solution for IM injection. | Biological | Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix) |
Primary outcome
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination
Time frame: Up to Day 8 (7 days after first vaccination on Day 1)
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination
Time frame: Up to Day 36 (7 days after second vaccination on Day 29)
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination
Time frame: Up to Day 64 (7 days after third vaccination on Day 57)
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
Number of Participants With Unsolicited AEs for 28 Days After First Vaccination
Time frame: Up to Day 29 (28 days after first vaccination on Day 1)
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination
Time frame: Up to Day 57 (28 days after second vaccination on Day 29)
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination
Time frame: Up to Day 85 (28 days after third vaccination on Day 57)
An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 2 year 10 months
Number of participants with SAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a suspected transmission of any infectious agent via a medicinal product, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
5 secondary outcomes
Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain
Time frame: Days 1, 8, 85, and 267 (End of first RSV season)
Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Time frame: Days 1, 8, 85, and 267 (End of first RSV season)
Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA
Time frame: Days 1, 8, 85, and 267 (End of first RSV season)
T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry
Time frame: Baseline (Day 1) and Day 85
Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI)
Time frame: Up to 2 year 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39220658Langley JM, Nolan TM, Ramet M, Richmond PC, Rosario Filho N, Haazen W, van den Berg SPH, Williams K, Bastian AR, Omoruyi E, Williams Durkin J, Salisch N, Van Geet G, van Duijnhoven W, Heijnen E, Callendret B. A Phase 1/2a Study Evaluating Safety and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers Aged 12-24 Months. Open Forum Infect Dis. 2024 Aug 8;11(9):ofae453. doi: 10.1093/ofid/ofae453. eCollection 2024 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Vaccines & Prevention B.V. Clinical Trial study director
Janssen Vaccines & Prevention B.V.
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ad26.RSV.preF and Nimenrix in people with Respiratory Syncytial Virus, run by Janssen Vaccines & Prevention B.V. at 25 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Brazil, Canada, Spain, Australia, Finland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination (time frame: Up to Day 8 (7 days after first vaccination on Day 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.