Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05229068




Registration number
NCT05229068
Ethics application status
Date submitted
27/01/2022
Date registered
8/02/2022
Date last updated
7/04/2022

Titles & IDs
Public title
A Study of Safety, Reactogenicity and Immune Response of the Repeat Vaccination Against RSV When Given to Female Participants of 18-49 Years of Age During Their Subsequent Uncomplicated Pregnancy
Scientific title
A Phase IIIB, Open Label, Non-randomized, Controlled, Multi-country Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Repeat Vaccination With 120 µg Dose of RSV Maternal Vaccine During Subsequent Pregnancy in Healthy Maternal Participants 18-49 Years of Age
Secondary ID [1] 0 0
2021-004012-25
Secondary ID [2] 0 0
214753
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
Other interventions - RSV MAT

Experimental: Prior_RSV MAT Group - Maternal participants who received a single 120 µg dose of RSV MAT vaccine at Day 1 in RSV MAT-004 (NCT04126213), RSV MAT-009 (NCT04605159) or RSV MAT-012 (NCT04980391) parent studies, will receive a single dose of RSV MAT vaccine at Day 1 in the current study and are followed-up until the study end (Day 181 post-delivery).

Experimental: Prior_Placebo Group - Maternal participants who received a single dose of placebo at Day 1 in RSV MAT-004 (NCT04126213), RSV MAT-009 (NCT04605159) or RSV MAT-012 (NCT04980391) parent studies or who did not participate in the parent studies and did not receive any RSV vaccine in the past*, will receive a single dose of RSV MAT vaccine at Day 1 in the current study and are followed-up until the study end (Day 181 post-delivery). *The unvaccinated participants are enrolled if the study cannot enroll sufficient numbers of the maternal participants who received placebo in the parent studies.


Other interventions: RSV MAT
Single 120 µg dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of maternal participants with solicited administration site events during the 7-day follow-up period after vaccination in the current study
Timepoint [1] 0 0
During the 7-day follow-up period after vaccination in the current study (administered at Day 1)
Primary outcome [2] 0 0
Percentage of maternal participants with solicited systemic events during the 7-day follow-up period after vaccination in the current study
Timepoint [2] 0 0
During the 7-day follow-up period after vaccination in the current study (administered at Day 1)
Primary outcome [3] 0 0
Percentage of maternal participants with unsolicited adverse events (AEs) during the 30-day follow-up period after vaccination in the current study
Timepoint [3] 0 0
During the 30-day follow-up period after vaccination in the current study (administered at Day 1)
Primary outcome [4] 0 0
Percentage of maternal participants with serious adverse events (SAEs), AEs leading to study withdrawal and medically attended AEs (MAEs) from Day 1 up to 42 days post-delivery in the current study
Timepoint [4] 0 0
From Day 1 up to 42 days post-delivery in the current study
Primary outcome [5] 0 0
Percentage of maternal participants with pregnancy outcomes from Day 1 up to 42 days post-delivery in the current study
Timepoint [5] 0 0
From Day 1 up to 42 days post-delivery in the current study
Primary outcome [6] 0 0
Percentage of maternal participants with pregnancy-related adverse events of special interest (AESIs) from Day 1 up to 42 days post-delivery in the current study
Timepoint [6] 0 0
From Day 1 up to 42 days post-delivery in the current study
Primary outcome [7] 0 0
Percentage of infant participants with neonatal / infant AESIs from birth up to 42 days post-birth in the current study
Timepoint [7] 0 0
From birth up to 42 days post-birth in the current study
Primary outcome [8] 0 0
Percentage of infant participants with SAEs, (S)AEs leading to study withdrawal and MAEs from birth up to 42 days post-birth in the current study
Timepoint [8] 0 0
From birth up to 42 days post-birth in the current study
Primary outcome [9] 0 0
RSV MAT immunoglobulin G (IgG)-specific antibody geometric mean concentrations (GMCs) for maternal participants at Day 31 post-vaccination in the current study
Timepoint [9] 0 0
At Day 31 post-vaccination in the current study
Primary outcome [10] 0 0
RSV MAT IgG-specific antibody GMCs for maternal participants at delivery in the current study
Timepoint [10] 0 0
At delivery in the current study
Primary outcome [11] 0 0
RSV-A neutralizing antibody geometric mean titers (GMTs) for maternal participants at Day 31 post-vaccination in the current study
Timepoint [11] 0 0
At Day 31 post-vaccination in the current study
Primary outcome [12] 0 0
RSV-A neutralizing antibody GMTs for maternal participants at delivery in the current study
Timepoint [12] 0 0
At delivery in the current study
Primary outcome [13] 0 0
RSV-B neutralizing antibody GMTs for maternal participants at Day 31 post-vaccination in the current study
Timepoint [13] 0 0
At Day 31 post-vaccination in the current study
Primary outcome [14] 0 0
RSV-B neutralizing antibody GMTs for maternal participants at delivery in the current study
Timepoint [14] 0 0
At delivery in the current study
Secondary outcome [1] 0 0
Percentage of maternal participants with SAEs and AEs leading to study withdrawal from Day 1 up to Day 181 post-delivery in the current study
Timepoint [1] 0 0
From Day 1 up to Day 181 post-delivery in the current study
Secondary outcome [2] 0 0
Percentage of maternal participants in Prior_RSV MAT group with solicited administration site events during the 7-day follow-up period after administration of the first and repeat vaccination
Timepoint [2] 0 0
During the 7-day follow-up period after administration of the first vaccination (administered at Day 1 in NCT04126213, NCT04605159 or NCT04980391 studies) and the repeat vaccination (administered at Day 1 in the current study)
Secondary outcome [3] 0 0
Percentage of maternal participants in Prior_RSV MAT group with solicited systemic events during the 7-day follow-up period after administration of the first and repeat vaccination
Timepoint [3] 0 0
During the 7-day follow-up period after administration of the first vaccination (administered at Day 1 in NCT04126213, NCT04605159 or NCT04980391 studies) and repeat vaccination (administered at Day 1 in the current study)
Secondary outcome [4] 0 0
Percentage of maternal participants in Prior_RSV MAT group with unsolicited AEs during the 30-day follow-up period after administration of the first and repeat vaccination
Timepoint [4] 0 0
During the 30-day follow-up period after administration of the first vaccination (administered at Day 1 in NCT04126213, NCT04605159 or NCT04980391 studies) and repeat vaccination (administered at Day 1 in the current study)
Secondary outcome [5] 0 0
Percentage of maternal participants in Prior_RSV MAT group with SAEs and AEs leading to study withdrawal from Day 1 up to Day 181 post-delivery after administration of the first and repeat vaccination
Timepoint [5] 0 0
From Day 1 up to Day 181 post-delivery after administration of the first vaccination in NCT04126213, NCT04605159 or NCT04980391 studies and repeat vaccination in the current study
Secondary outcome [6] 0 0
Percentage of maternal participants in Prior_RSV MAT group with MAEs from Day 1 up to 42 days post-delivery after administration of the first and the repeat vaccination
Timepoint [6] 0 0
From Day 1 up to 42 days post-delivery after administration of the first vaccination in NCT04126213, NCT04605159 or NCT04980391 studies and repeat vaccination in the current study
Secondary outcome [7] 0 0
Percentage of maternal participants in Prior_RSV MAT group with pregnancy outcomes from Day 1 up to 42 days post-delivery after administration of the first and repeat vaccination
Timepoint [7] 0 0
From Day 1 up to 42 days post-delivery after administration of the first vaccination in NCT04126213, NCT04605159 or NCT04980391 studies and repeat vaccination in the current study
Secondary outcome [8] 0 0
Percentage of maternal participants in Prior_RSV MAT group with pregnancy-related AESIs from Day 1 up to 42 days post-delivery after administration of the first and repeat vaccination
Timepoint [8] 0 0
From Day 1 up to 42 days post-delivery after administration of the first vaccination in NCT04126213, NCT04605159 or NCT04980391 studies and repeat vaccination in the current study
Secondary outcome [9] 0 0
Percentage of infant participants with SAEs, (S)AEs leading to study withdrawal and MAEs from birth up to Day 366 post-birth in the current study
Timepoint [9] 0 0
From birth up to Day 366 post-birth in the current study
Secondary outcome [10] 0 0
RSV MAT IgG-specific antibody GMCs for maternal participants in Prior_RSV MAT group at Day 31 post-repeat and first vaccination
Timepoint [10] 0 0
At Day 31 post-repeat vaccination administered in the current study and first vaccination administered in NCT04126213, NCT04605159 or NCT04980391 studies
Secondary outcome [11] 0 0
RSV MAT IgG-specific antibody GMCs for maternal participants in Prior_RSV MAT group at delivery post-repeat and first vaccination
Timepoint [11] 0 0
At delivery post-repeat vaccination administered in the current study and first vaccination administered in NCT04126213, NCT04605159 or NCT04980391 studies
Secondary outcome [12] 0 0
RSV-A neutralizing antibody GMTs for maternal participants in Prior_RSV MAT group at Day 31 post-repeat and first vaccination
Timepoint [12] 0 0
At Day 31 post-repeat vaccination administered in the current study and first vaccination administered in NCT04126213, NCT04605159 or NCT04980391 studies
Secondary outcome [13] 0 0
RSV-A neutralizing antibody GMTs for maternal participants in Prior_RSV MAT group at delivery post-repeat and first vaccination
Timepoint [13] 0 0
At delivery post-repeat vaccination administered in the current study and first vaccination administered in NCT04126213, NCT04605159 or NCT04980391 studies
Secondary outcome [14] 0 0
RSV-B neutralizing antibody GMTs for maternal participants in Prior_RSV MAT group at Day 31 post-repeat and first vaccination
Timepoint [14] 0 0
At Day 31 post-repeat vaccination administered in the current study and first vaccination administered in NCT04126213, NCT04605159 or NCT04980391 studies
Secondary outcome [15] 0 0
RSV-B neutralizing antibody GMTs for maternal participants in Prior_RSV MAT group at delivery post-repeat and first vaccination
Timepoint [15] 0 0
At delivery post-repeat vaccination administered in the current study and first vaccination administered in NCT04126213, NCT04605159 or NCT04980391 studies
Secondary outcome [16] 0 0
Geometric mean ratio between cord blood and maternal RSV MAT IgG-specific antibody concentrations at delivery in the current study
Timepoint [16] 0 0
At delivery in the current study
Secondary outcome [17] 0 0
RSV MAT IgG-specific antibody GMCs for infant participants at delivery in the current study
Timepoint [17] 0 0
At delivery in the current study
Secondary outcome [18] 0 0
RSV-A neutralizing antibody GMTs for infant participants at delivery in the current study
Timepoint [18] 0 0
At delivery in the current study
Secondary outcome [19] 0 0
RSV-B neutralizing antibody GMTs for infant participants at delivery in the current study
Timepoint [19] 0 0
At delivery in the current study

Eligibility
Key inclusion criteria
Maternal participants

- Only those pregnant participants who received a single 120 µg dose of RSV MAT vaccine
or placebo in the RSV MAT-004, RSV MAT-009 or RSV MAT-012 studies OR healthy pregnant
participants who had at least one prior live birth and have not received any RSV
vaccine in the past.

- 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 participants
prior to performance of any study-specific procedure. The informed consent given at
screening should (consistent with local regulations/guidelines) either:

- include consent for both the maternal participant's participation and
participation of the infant after the infant's birth, or

- include consent for the maternal participant's participation and expressed
willingness to consider permitting the infant to take part after the infant's
birth (if local regulations/guidelines require parent(s) to provide an additional
informed consent after the infant's birth).

- Both mother and father should consent if local regulations/guidelines require it.

- In good general maternal health as established by medical history and clinical
examination before entering into the study.

- Participants between and including 18 and 49 YOA, inclusive at the time of consent.

- Pre-pregnancy body mass index (based on participant's report) 17 to 39.9 kg/m^2,
inclusive.

- Singleton pregnancy (including instances where the singleton pregnancy derives from a
vanishing twin syndrome).

- Pregnant females at 24^0/7 to 36^0/7 weeks of gestation at the time of study
intervention administration (Visit 1), as established by:

- last menstrual period (LMP) date corroborated by first or second trimester
ultrasound examination (U/S) i.e. at or before 28 weeks of gestation.

- First or second trimester U/S only, if LMP is unknown/uncertain.

- Certain LMP, corroborated by a U/S performed after 28 weeks of gestation is also
acceptable.

NOTE: If pregnancy resulted from assisted reproductive technologies, LMP date may be
replaced by IUI (intrauterine insemination) or ET (embryo-transfer) date.

- No fetal genetic abnormalities (based on genetic testing, if performed).

- No significant congenital malformations conducted at or beyond 18 weeks of gestation.

- Participants who are willing to provide cord blood.

- Participants who do not plan to give their offspring for adoption or place the child
in care.

- Participants who plan to reside in the study area for at least one year after
delivery.

- Willing to have their infant followed-up after delivery for a period of 12 months.

Note that women whose pregnancies resulted from Assisted Reproductive Technologies may be
enrolled if they meet all inclusion criteria and none of the exclusion criteria.

Infant participants

- Live-born from the study pregnancy.

- If required per local regulations/guidelines, re-signed (confirmed) written or
witnessed/thumb printed informed consent for study participation of the infant
obtained from the infant's mother and/or father and/or LAR, before performing any
study-specific procedure. To comply other protocol required procedures that begin
immediately after birth: If written consent cannot be provided by the infant's
parent(s)/LAR(s) readily post-birth, verbal consent, if permitted per local
regulation, may be sought from the infant's parent(s)/LAR(s) instead. Verbal consent
should be documented in the source data by the investigator or delegate. The infant's
parent(s)/LAR(s) will provide additional, written informed consent by (or before)
Visit 2-NB.
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Maternal participants

Medical conditions

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the study intervention.

- Hypersensitivity to latex.

- Acute or chronic clinically significant abnormality or poorly controlled pre-existing
condition or any other clinical conditions.

- Subjects who have received 2 or more doses of any RSV vaccine in the past.

- Significant complications in the current pregnancy such as:

- Gestational hypertension at =20 weeks of gestation in the absence of proteinuria
in a woman with a previously normal blood pressure.

- Gestational diabetes which is not controlled by medication, diet and/or exercise

- Pre-eclampsia

- Eclampsia

- Intrauterine Growth Restriction/Fetal Growth Restriction

- Placenta previa

- Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any
abnormalities

- Polyhydramnios

- Oligohydramnios

- Preterm labor or history of preterm labor in the current pregnancy.

- Any intervention to prevent preterm delivery or medical treatment for suspected
preterm delivery

- Cholestasis

- Other pregnancy-related complications

- History of 2 or more prior stillbirths or neonatal deaths, or history of 2 or more
preterm births at = 34 weeks gestation, or 3 or more consecutive spontaneous
abortions.

- Significant structural abnormalities of the uterus or cervix.

- Known human immunodeficiency virus infection, as assessed by local standard of care
serologic tests.

- Known or suspected hepatitis B or C virus infection.

- Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus
B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex.

- Active infection with tuberculosis.

- Any confirmed or suspected immunosuppressive or immunodeficient condition.

- Current autoimmune disorder.

- Lymphoproliferative disorder or malignancy within 5 years before study vaccination.

- Any conditions that, in the investigator's judgement, may interfere with participant's
ability to comply with study procedures or receipt of prenatal care.

- Any condition which, in the investigator's opinion, would increase the risks of study
participation to the unborn infant.

Prior/Concomitant therapy

- Prior receipt of any RSV vaccine in the current pregnancy or prior receipt of 2 or
more doses of any RSV vaccine prior to study vaccination.

- Use of any investigational or non-registered product other than the study
vaccine/product, or planned use during the study period).

The exception to this are investigational products administered in the setting of a
pandemic.

- Planned administration/administration of any vaccine within 29 days before study
vaccine administration (Day -28 to Day 1) or planned administration through delivery,
except:

- Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines,
dTpa/Tdap vaccines that also contain other antigens and Hepatitis B vaccines,
which may be administered = 15 days before or after study vaccination.

- Note that if public health authorities organize an emergency mass
vaccination for an unforeseen public health threat (e.g.: a pandemic)
outside the routine immunisation program, then the intervals described above
can be reduced if necessary for that mass vaccination vaccine, provided the
vaccine is licensed and used according to its Product Information. In that
sense, COVID-19 vaccines may be allowed, when administered = 15 days before
or after study vaccination.

- Administration of immunoglobulins (except anti-Rh0D IG, which may be administered at
any time), blood products or plasma derivatives within 3 months before study
vaccination or planned administration through delivery (Visit 3).

- Administration of immune-modifying therapy within 6 months before the study
vaccination, or planned administration through delivery.

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.

- Subjects who were lost to follow-up or prematurely withdrawn before Day 43 in the RSV
MAT-004, RSV MAT-009 and RSV MAT-012 studies.

Other exclusions

- Alcoholism or substance use disorder within the past 24 months based on the presence
of 2 or more abuse criteria.

- A local condition that in the opinion of the Investigator precludes injection of the
study vaccine/product or precludes assessment of local (administration site)
reactogenicity.

- Consanguinity of maternal participant and her partner.

- Any study personnel or their immediate dependents, family, or household members.

Infant participants

- 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 vaccine/product.

- Any condition which, in the investigator's opinion, would increase the risks of study
participation to the infant.

- Child in care.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
11/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/10/2024
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Montana
Country [2] 0 0
United States of America
State/province [2] 0 0
Nebraska

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a
single intramuscular dose of the investigational respiratory syncytial virus (RSV) maternal
(RSV MAT) vaccine during subsequent uncomplicated pregnancy in maternal participants, 18 to
49 years of age (YOA), who have previously received the RSV MAT vaccine or placebo in the RSV
MAT-004 (NCT04126213), RSV MAT-009 (NCT04605159) and RSV MAT-012 (NCT04980391) primary
studies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05229068
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05229068