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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04126213




Registration number
NCT04126213
Ethics application status
Date submitted
11/10/2019
Date registered
15/10/2019

Titles & IDs
Public title
Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants
Scientific title
A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers
Secondary ID [1] 0 0
2019-001991-12
Secondary ID [2] 0 0
209544
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
Treatment: Other - RSV MAT 60 µg
Treatment: Other - RSV MAT 120 µg
Treatment: Drugs - Placebo

Experimental: RSV MAT 60 Group-Mother - Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.

Experimental: RSV MAT 120 Group-Mother - Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.

Placebo comparator: Control Group-Mother - Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.

No intervention: RSV MAT 60 Group-Infant - This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.

No intervention: RSV MAT 120 Group-Infant - This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.

No intervention: Control Group-Infant - This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.


Treatment: Other: RSV MAT 60 µg
One single dose of RSV MAT 60 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Treatment: Other: RSV MAT 120 µg
One single dose of RSV MAT 120 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Treatment: Drugs: Placebo
One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Maternal Subjects With Any Solicited Administration Site Events
Timepoint [1] 0 0
During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)
Primary outcome [2] 0 0
Percentage of Maternal Subjects With Any Solicited Systemic Events
Timepoint [2] 0 0
During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)
Primary outcome [3] 0 0
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
Timepoint [3] 0 0
At Day 8
Primary outcome [4] 0 0
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Timepoint [4] 0 0
At Day 8
Primary outcome [5] 0 0
Percentage of Maternal Subjects With Any Unsolicited Adverse Events (AEs)
Timepoint [5] 0 0
During 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days)
Primary outcome [6] 0 0
Percentage of Maternal Subjects With Any Serious Adverse Events (SAEs)
Timepoint [6] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [7] 0 0
Percentage of Maternal Subjects With AEs Leading to Study Withdrawal
Timepoint [7] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [8] 0 0
Percentage of Maternal Subjects With Any Medically Attended AEs (MAE)
Timepoint [8] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [9] 0 0
Percentage of Maternal Subjects With Pregnancy Outcomes
Timepoint [9] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [10] 0 0
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Timepoint [10] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [11] 0 0
Percentage of Infant Subjects With Neonatal AESIs
Timepoint [11] 0 0
From birth to Day 43 post-birth
Primary outcome [12] 0 0
Percentage of Infant Subjects With Any SAEs
Timepoint [12] 0 0
From birth to Day 43 post-birth
Primary outcome [13] 0 0
Percentage of Infant Subjects With AEs Leading to Study Withdrawal
Timepoint [13] 0 0
From birth to Day 43 post-birth
Primary outcome [14] 0 0
Percentage of Infant Subjects With Any MAEs
Timepoint [14] 0 0
From birth to Day 43 post-birth
Primary outcome [15] 0 0
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations in Terms of Geometric Mean Concentrations (GMCs) in Maternal Subjects
Timepoint [15] 0 0
At Day 1 (before vaccination), Day 31 and at delivery
Primary outcome [16] 0 0
RSV-A Neutralizing Antibody Geometric Mean Titers (GMTs) in Maternal Subjects
Timepoint [16] 0 0
At Day 1 (before vaccination), Day 31 and at delivery
Primary outcome [17] 0 0
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects
Timepoint [17] 0 0
At delivery or within 3 days after birth
Primary outcome [18] 0 0
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects
Timepoint [18] 0 0
At delivery or within 3 days after birth
Primary outcome [19] 0 0
Geometric Mean Ratio Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations
Timepoint [19] 0 0
At delivery (for maternal subjects) or within 3 days after birth (for infants)
Secondary outcome [1] 0 0
Percentage of Maternal Subjects With Any SAE From Day 1 to Day 181 Post Delivery
Timepoint [1] 0 0
From Day 1 to Day 181 post-delivery
Secondary outcome [2] 0 0
Percentage of Maternal Subjects With Any MAE From Day 1 to Day 181 Post Delivery
Timepoint [2] 0 0
From Day 1 to Day 181 post-delivery
Secondary outcome [3] 0 0
Percentage of Maternal Subjects With AE Leading to Study Withdrawal From Day 1 to Day 181 Post Delivery
Timepoint [3] 0 0
From Day 1 to Day 181 post-delivery
Secondary outcome [4] 0 0
Percentage of Infant Subjects With Any SAE From Birth to Day 181 Post-birth
Timepoint [4] 0 0
From birth to Day 181 post-birth
Secondary outcome [5] 0 0
Percentage of Infant Subjects With AE Leading to Study Withdrawal From Birth to Day 181 Post-birth
Timepoint [5] 0 0
From birth to Day 181 post-birth
Secondary outcome [6] 0 0
Percentage of Infant Subjects With Any MAE From Birth to Day 181 Post-birth
Timepoint [6] 0 0
From birth to Day 181 post-birth
Secondary outcome [7] 0 0
Percentage of Infant Subjects With Any SAE From Birth to Month 12 Post-birth
Timepoint [7] 0 0
From birth to Month 12 post-birth
Secondary outcome [8] 0 0
Percentage of Infant Subjects With Any AE Leading to Study Withdrawal From Birth to Month 12 Post-birth
Timepoint [8] 0 0
From birth to Month 12 post-birth
Secondary outcome [9] 0 0
Percentage of Infant Subjects With Any MAE From Birth to Month 12 Post-birth
Timepoint [9] 0 0
From birth to Month 12 post-birth
Secondary outcome [10] 0 0
Percentage of Maternal Subjects With RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI)
Timepoint [10] 0 0
From delivery to Day 181 post-delivery
Secondary outcome [11] 0 0
Percentage of Infant Subjects With RSV-associated Lower Respiratory Tract Illness (LRTI)
Timepoint [11] 0 0
From birth to Day 181 post-birth
Secondary outcome [12] 0 0
Percentage of Infant Subjects With RSV-associated Severe LRTI
Timepoint [12] 0 0
From birth to Day 181 post-birth
Secondary outcome [13] 0 0
Percentage of Infant Subjects With RSV-associated Very Severe LRTI
Timepoint [13] 0 0
From birth to Day 181 post-birth
Secondary outcome [14] 0 0
Percentage of Infant Subjects With RSV-associated Hospitalisation
Timepoint [14] 0 0
From birth to Day 181 post-birth
Secondary outcome [15] 0 0
RSV MAT IgG Antibody GMCs in Maternal Subjects, at Day 43 Post-delivery
Timepoint [15] 0 0
At Day 43 post-delivery
Secondary outcome [16] 0 0
RSV-A Neutralizing Antibody GMTs in Maternal Subjects, at Day 43 Post-delivery
Timepoint [16] 0 0
At Day 43 post-delivery
Secondary outcome [17] 0 0
RSV-B Neutralizing Antibody GMTs in Maternal Subjects
Timepoint [17] 0 0
At Day 1 (before vaccination), Day 31, at delivery and Day 43 post-delivery
Secondary outcome [18] 0 0
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 43 After Birth
Timepoint [18] 0 0
At Day 43 after birth
Secondary outcome [19] 0 0
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 121 After Birth
Timepoint [19] 0 0
At Day 121 after birth
Secondary outcome [20] 0 0
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 181 After Birth
Timepoint [20] 0 0
At Day 181 after birth
Secondary outcome [21] 0 0
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Timepoint [21] 0 0
At Day 43 after birth
Secondary outcome [22] 0 0
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Timepoint [22] 0 0
At Day 121 after birth
Secondary outcome [23] 0 0
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Timepoint [23] 0 0
At Day 181 after birth
Secondary outcome [24] 0 0
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Birth
Timepoint [24] 0 0
At delivery or within 3 days after birth
Secondary outcome [25] 0 0
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Timepoint [25] 0 0
At Day 43 after birth
Secondary outcome [26] 0 0
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Timepoint [26] 0 0
At Day 121 after birth
Secondary outcome [27] 0 0
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Timepoint [27] 0 0
At Day 181 after birth

Eligibility
Key inclusion criteria
Maternal subjects

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Subjects who give written or witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements, and before any study specific procedures are performed. The informed consent given at screening should (consistent with local regulations / guidelines) either:

* include consent for both the maternal subject's participation and participation of the infant after the infant's birth, or
* include consent for the maternal subject's participation and expressed willingness to consider permitting the infant to take part after the infant's birth.
* Both mother and father should consent if local regulations/guidelines require it.
* Age 18 to 40 years, inclusive, when informed consent is given.
* Pre-pregnancy BMI 18.5 to 34.9, inclusive
* Healthy as established by medical history and clinical examination before entering into the study.
* At 28^0/7 to 33^6/7 weeks of gestation at the time of study vaccination (Visit 1), as established by last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S).

* If LMP and U/S do not correlate, default to U/S gestational age assessment. The level of diagnostic certainty of the gestational age should be established by using the Global Alignment of Immunisation safety Assessment in pregnancy gestation age assessment tool
* Subject satisfying screening requirements
* Singleton pregnancy
* HIV negative, as assessed by local standard of care serologic tests conducted during the current pregnancy and before enrolment (Visit 1).
* No fetal genetic abnormalities.
* No significant congenital malformations, as assessed by level 2 ultrasound (also known as a fetal anomaly ultrasound scan or fetal morphology assessment) conducted after 18 weeks of gestation
* Willing to provide cord blood
* Willing to have the infant followed-up after delivery for a period of 12 months
* Does not plan after delivery to give the infant for adoption or place the infant in care 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 subjects

* Live-born from the study pregnancy.
* 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 legally authorized representative, as applicable by local law, before performing any study specific procedure.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Maternal subjects

Medical conditions

* History of allergic disease or reactions likely to be exacerbated by any component of the RSV vaccine
* Hypersensitivity to latex
* 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 diet and exercise
* Pre-eclampsia
* Eclampsia during current pregnancy
* Intrauterine growth restriction
* Placenta previa
* Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities that in the opinion of Investigator can impair the maternal-fetal circulation
* Polyhydramnios
* Oligohydramnios
* Cervical suture in place
* Preterm labour or history of preterm labour in the current pregnancy
* Ongoing medical intervention to prevent preterm delivery or medical treatment for suspected preterm delivery
* Cholestasis
* Other pregnancy-related complications that in the Investigator's judgement would preclude participation of the subjects in an investigational vaccine trial or might pose risk to the subject due to participation in the study
* Significant structural abnormalities of the uterus or cervix
* History of prior stillbirth or neonatal death
* History of preterm birth
* History of =2 spontaneous abortions
* Known or suspected HBV or HCV infection, based on medical history and clinical presentation
* Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex, based on medical history and clinical presentation
* Active infection with tuberculosis, based on medical history and clinical presentation
* Known or suspected impairment of the immune system or autoimmune disorder (based on medical history and physical examination; no laboratory testing required)
* Lymphoproliferative disorder or malignancy within 5 years before vaccination (excluding effectively treated non-melanoma skin cancer)
* Any clinically significant grade 1 hematological and/or biochemical laboratory abnormalities identified at screening, which are clinically significant for pregnant women in the second and third trimester
* Grade = 2 hematological and/or biochemical laboratory abnormalities identified at screening being clinically significant for pregnant women in the second and third trimester
* Acute or chronic clinically significant conditions, that might pose additional risk to the subject due to participation in the study
* Any conditions that, may interfere with subject's ability to comply with study procedures or receipt of prenatal care
* Any condition which, would increase the risks of study participation to the unborn infant

Prior/Concomitant therapy

* Prior receipt of a COVID-19 vaccine.
* Prior receipt of an RSV vaccine
* Use of any investigational or non-registered product other than the study vaccine(s)/product(s) during the period beginning 29 days before the dose of study vaccine/product or planned use during the study period
* Planned administration/administration of any vaccine within 29 days before study vaccine administration and through Day 43 post-delivery, except seasonal influenza vaccines and dTpa/Tdap or tetanus, which may be administered according to standard of care = 15 days before or after study vaccination
* Administration of immunoglobulins, blood products or plasma derivatives within 3 months before study vaccination or planned administration through Visit 5
* Administration of immune-modifying therapy within 6 months before the study vaccine/product dose, or planned administration through delivery. This includes but is not limited to:

* Azathioprine, mycophenolate mofetil, 6-mercaptopurine, cyclosporine, tacrolimus, monoclonal or polyclonal antibodies;
* Prednisone, = 5 mg/day or equivalent for = 14 days. Topical, steroids are allowed. Inhaled steroids are allowed if = 500µg/day of beclomethasone or fluticasone, or = 800µg/day of budesonide.

Prior/Concomitant clinical study experience

* Previous participation in a clinical trial of an RSV vaccine
* Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product

Other exclusions

* Alcoholism or substance use disorder within the past 24 months based on the presence of two or more abuse criteria
* A local condition that precludes injection of the study drug or precludes assessment of local reactogenicity
* Consanguinity of maternal subject and her partner (second degree cousins or closer)
* Any study personnel or their immediate dependants, family, or household members

Infant subjects

* Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
* 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
5/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/05/2021
Sample size
Target
Accrual to date
Final
534
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Nova Scotia
Country [12] 0 0
Canada
State/province [12] 0 0
Québec
Country [13] 0 0
Finland
State/province [13] 0 0
Helsinki
Country [14] 0 0
France
State/province [14] 0 0
Clermont Ferrand
Country [15] 0 0
France
State/province [15] 0 0
Saint Etienne Cedex 02
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland
Country [17] 0 0
New Zealand
State/province [17] 0 0
Wellington
Country [18] 0 0
Panama
State/province [18] 0 0
Panama City
Country [19] 0 0
Panama
State/province [19] 0 0
Panama
Country [20] 0 0
South Africa
State/province [20] 0 0
Gauteng
Country [21] 0 0
Spain
State/province [21] 0 0
Andalucia
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Burgos
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Majadahonda (Madrid)
Country [26] 0 0
Spain
State/province [26] 0 0
Marbella

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04126213