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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05169905




Registration number
NCT05169905
Ethics application status
Date submitted
10/12/2021
Date registered
27/12/2021
Date last updated
7/04/2023

Titles & IDs
Public title
A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age
Scientific title
A Phase III, Randomized, Open-label, Active Vaccine-controlled Crossover Study to Evaluate the Reactogenicity, Safety and Immune Response of Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Girls From 9 to 17 Years of Age, and in Non-pregnant Adult Women From 18 to 49 Years of Age
Secondary ID [1] 0 0
2021-004003-41
Secondary ID [2] 0 0
217354
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Product - RSV MAT vaccine
Combination Product - dTpa vaccine

Experimental: RSV_dTpa-P Group - Healthy non-pregnant girls 9-17 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.

Experimental: dTpa_RSV-P Group - Healthy non-pregnant girls 9-17 years of age were scheduled to receive a single dose of dTpa vaccine at Day 1 and a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration), but there were no participants assigned to this study group, and hence, there was no vaccine administered in this study group.

Experimental: RSV_dTpa-A Group - Healthy non-pregnant adult women 18-49 years of age received a single dose of RSV MAT vaccine at Day 1 and were scheduled to receive a single dose of dTpa vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). Participants who were enrolled and were due to receive the dTpa vaccine at Day 31, did no longer receive the dTpa as part of this study, but they were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.

Experimental: dTpa_RSV-A Group - Healthy non-pregnant adult women 18-49 years of age received a single dose of dTpa vaccine at Day 1 and were scheduled to receive a single dose of RSV MAT vaccine at Day 31 and to be followed-up until end of study (180 days post-vaccine administration). RSV MAT vaccine was no longer administered to participants at Day 31.


Combination Product: RSV MAT vaccine
Single dose of the RSV MAT vaccine reconstituted with NaCl solution was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule.
RSV MAT vaccine was no longer administered to participants at Day 31. No vaccine was administered in the dTpa_RSV-P Group, since there were no participants assigned to it.

Combination Product: dTpa vaccine
Single dose of the dTpa vaccine was planned to be administered intramuscularly, in the non-dominant arm, at Day 1 or at Day 31, depending on the vaccination schedule.
Two formulations of dTpa vaccine are licensed in the US and outside of the US (ex-US), respectively. dTpa-US formulation was administered to participants in centers located in the US, while dTpa-ex-US formulation was planned to be administered to participants in centers ex-US. The dTpa-ex-US formulation was not applicable in this study anymore as no non-US sites were initiated before the decision to stop the study.
The participants in RSV_dTpa-P and RSV_dTpa-A study groups were provided with an option to decide to receive dTpa vaccination as part of standard of care/local recommendation on immunization.
No vaccine was administered in the dTpa_RSV-P Group, since there were no participants assigned to it.
Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Reporting Any Serious Adverse Events (SAEs)
Timepoint [1] 0 0
During the entire study period (from Day 1 up to Day 181)
Primary outcome [2] 0 0
Number of Participants Reporting Adverse Events (AEs)/SAEs Leading to Study Withdrawal
Timepoint [2] 0 0
During the entire study period (from Day 1 up to Day 181)
Primary outcome [3] 0 0
Number of Participants Reporting Any Solicited Administration Site Events
Timepoint [3] 0 0
During the 7 days follow-up period post-Dose 1
Primary outcome [4] 0 0
Number of Participants Reporting Any Solicited Systemic Events
Timepoint [4] 0 0
During the 7 days follow-up period post-Dose 1
Primary outcome [5] 0 0
Number of Participants Reporting Any Unsolicited AEs
Timepoint [5] 0 0
During the 30 days follow-up period post-Dose 1
Primary outcome [6] 0 0
Number of Participants Reporting SAEs and Medically Attended Adverse Events (MAEs)
Timepoint [6] 0 0
During the 30 days follow-up period post-Dose 1
Primary outcome [7] 0 0
Number of Participants Reporting AEs/SAEs/MAEs Leading to Study Withdrawal
Timepoint [7] 0 0
During the 30 days follow-up period post-Dose 1
Secondary outcome [1] 0 0
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Timepoint [1] 0 0
At pre-dosing (Day 1)
Secondary outcome [2] 0 0
RSV-A Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Timepoint [2] 0 0
At 30 days post-RSV MAT vaccine administration (Day 31)
Secondary outcome [3] 0 0
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Timepoint [3] 0 0
At pre-dosing (Day 1)
Secondary outcome [4] 0 0
RSV-B Neutralizing Antibody Titers for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Timepoint [4] 0 0
At 30 days post-RSV MAT vaccine administration (Day 31)
Secondary outcome [5] 0 0
RSV MAT Immunoglobulin G (IgG) Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 1
Timepoint [5] 0 0
At pre-dosing (Day 1)
Secondary outcome [6] 0 0
RSV MAT IgG Antibody Concentrations for Participants in RSV_dTpa-P Group and RSV_dTpa-A Group at Day 31
Timepoint [6] 0 0
At 30 days post-RSV MAT vaccine administration (Day 31)

Eligibility
Key inclusion criteria
Healthy Non-pregnant Adult Women from 18-49 YOA

* Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
* A healthy female participant, as established by medical history and clinical examination, between and including 18 to 49 YOA at the time of the first study intervention administration.
* Body mass index (based on participant's report) 17.0 to 39.9 kg/m^2, inclusive for adult participants.
* Female participants of childbearing potential may be enrolled in the study, if the participant:

* has practiced adequate contraception for 1 month prior to study intervention administration, and
* has a negative pregnancy test on the day of study intervention administration, and
* has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administrations.
* Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

Healthy non-pregnant Girls from 9-17 YOA

* Participants and participants' parent(s)/Legally Acceptable Representative(s) (LAR), who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written or witnessed/thumb printed informed consent obtained from the participant*/parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.

* *Written informed consent obtained from parents/LARs and written informed assent obtained from the participant if she is less than legal age. The legal age is determined according to local regulations in each participating country.
* In case the legal age is achieved during the conduct of the study, an additional written informed consent from the participant should be obtained at the time of the legal age.
* A healthy female participant between and including 9 and 17 YOA at the time of the first study intervention administration.

* Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, or bilateral ovariectomy.
* Body mass index by age between 5 percentile and 95 percentile (inclusive) for pediatric participants.
* Female participants of childbearing potential may be enrolled in the study, if the participant:

* has a negative pregnancy test on the day of study intervention administration, and is abstinent during the entire treatment period and for 1 month before and after completion of the study intervention administration series (and if so, this is to be documented in the source documents at each vaccination visit)
* or has practiced adequate contraception for 1 month prior to study intervention administration and has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
Minimum age
9 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical conditions

* Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Current autoimmune disorder (based on medical history and physical examination), for which the participant has received immune-modifying therapy within 6 months, before study vaccination.
* Hypersensitivity to latex.
* Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination or medical history that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* Significant or uncontrolled psychiatric illness.
* Documented human immunodeficiency virus (HIV)-positive participant.
* Any clinically significant* hematological parameter and/or biochemical laboratory abnormality from the test requested by the investigator based on medical judgment prior to enrolment

* *The investigator should use his/her clinical judgment to decide whether the test is needed, and which abnormalities are clinically significant. If he/she decides to run this test, the investigator will need to review the test results before proceeding with the administration of the study vaccine.
* Lymphoproliferative disorder or malignancy within 5 years before study vaccination (excluding effectively treated non-melanoma skin cancer).

Prior/Concomitant therapy

* Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention(s) during the period beginning 30 days before the first doses (Day -29 to Day 1), or their planned use during the study period.
* Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention(s)* administration with the exception of any licensed influenza vaccine which may be administered = 15 days before or after study vaccinations (dTpa and RSV maternal vaccines).

* *In case emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine (if it is used according to the local governmental recommendations and that the Sponsor is notified accordingly). Therefore, COVID-19 vaccines will be allowed, when administered = 15 days before or after study vaccinations (dTpa and RSV maternal vaccines).
* Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration during the study period.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s) to 2 months after first vaccination. For corticosteroids, this will mean prednisone equivalent =5 mg/day for adult participants/ =0.5 mg/kg/day. Inhaled and topical steroids are allowed.
* Previous experimental vaccination against RSV.
* Boostrix (dTpa) administration for which the vaccination is not aligned with the local recommendations for dTap vaccination or not aligned with the locally approved Boostrix (dTpa) prescribing information.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).

Other exclusions

* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Alcoholism or substance use disorder within the past 24 months based on the presence of two or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglected major roles to use, withdrawal tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving.
* Any study personnel or their immediate dependents, family, or household members.
* Child in care.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2022
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT05169905