GRACE: A Phase III Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04605159
• Collaborator: (none)
• Enrollment: 10,578
• Locations: 167
• Arms: 2
• Anticipated Duration (Months): 31.7
• Patients Per Site: 63.3
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant.

Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants will continue to be monitored as part of the study.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infections	Biological: RSV MAT; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 10578 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Following the decision to stop enrollment and vaccination, the study/site staff and maternal participants no longer stay blinded.
• Primary Purpose: Prevention
• Official Title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of a Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants up to 6 Months of Age
• Actual Study Start Date: Nov 20, 2020
• Anticipated Primary Completion Date: Jul 13, 2023
• Anticipated Study Completion Date: Jul 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RSV_MAT Group Maternal participants randomized to the RSV_MAT Group will receive a single dose of RSV MAT vaccine at day 1, via the intramuscular route; the preferred injection site will be the deltoid region of the non-dominant arm.	Biological: RSV MAT; One dose of RSV MAT vaccine reconstituted with NaCl solution administered intramuscularly in the non-dominant arm.
Placebo Comparator: Control Group Maternal participants randomized to the Control Group will receive a single dose of Placebo at day 1, via the intramuscular route; the preferred injection site will be the deltoid region of the non-dominant arm.	Drug: Placebo; One dose of lyophilized sucrose reconstituted with NaCl solution administered intramuscularly in the non-dominant arm.

Outcome Measures

Primary Outcome Measures

1. Number of infant participants with medically assessed, RSV-associated LRTIs, up to 6 months of age [From birth to Day 181 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of severe and/or any medically assessed, RSV-associated LRTIs.

2. Number of infant participants with at least one SAE, AE leading to study termination or Medically Attended AE (MAE), from birth up to 6 months after birth [From birth to Month 6 post birth]

   A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. A MAE is an unsolicited AE such as a symptom or illness which requires a hospitalisation, or emergency room visit, or visit to/by a health care provider.

3. Number of infant participants with at least one SAE, AE leading to study termination or MAE, from birth up to 12 months after birth [From birth to Month 12 post birth]

   A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. A MAE is an unsolicited AE such as a symptom or illness which requires a hospitalisation, or emergency room visit, or visit to/by a health care provider.

Secondary Outcome Measures

1. Number of infant participants with RSV-associated hospitalizations [From birth to Day 181 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of RSV associated hospitalizations.

2. Number of infant participants with all-cause LRTIs [From birth to Day 181 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of all-cause LRTIs.

3. Number of infant participants with all-cause LRTIs with hospitalization [From birth to Day 181 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of all-cause LRTIs with hospitalization.

4. Number of infant participants with medically assessed, RSV-associated severe LRTIs, up to 7 months of age [From birth to Day 211 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe LRTIs.

5. Number of infant participants with medically assessed, RSV-associated severe LRTIs, up to 8 months of age [From birth to Day 241 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe LRTIs.

6. Number of infant participants with medically assessed, RSV-associated severe LRTIs, up to 9 months of age [From birth to Day 271 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe LRTIs.

7. Number of infant participants with medically assessed, RSV-associated severe LRTIs, up to 10 months of age [From birth to Day 301 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe LRTIs.

8. Number of infant participants with medically assessed, RSV-associated severe LRTIs, up to 11 months of age [From birth to Day 331 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe LRTIs.

9. Number of infant participants with medically assessed, RSV-associated severe LRTIs, up to 12 months of age [From birth to Day 366 post birth]

   The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe LRTIs.

10. Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 7 months of age [From birth to Day 211 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.

11. Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 8 months of age [From birth to Day 241 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.

12. Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 9 months of age [From birth to Day 271 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.

13. Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 10 months of age [From birth to Day 301 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.

14. Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 11 months of age [From birth to Day 331 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.

15. Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 12 months of age [From birth to Day 366 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.

16. Number of infant participants with severe medically assessed, RSV-associated LRTIs for RSV subtype A and RSV subtype B separately, up to 6 months of age [From birth to Day 181 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of severe medically assessed, RSV-associated LRTIs for RSV subtype A and RSV subtype B separately.

17. Number of infant participants with any medically assessed, RSV-associated LRTIs for RSV subtype A and RSV subtype B separately, up to 6 months of age [From birth to Day 181 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs for RSV subtype A and RSV subtype B separately.

18. Number of infant participants with medically assessed, RSV-associated LRTIs, up to 4 months of age [From birth to Day 121 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of severe and any medically assessed, RSV-associated LRTIs.

19. Number of infant participants with medically assessed, RSV LRTIs [From birth to Day 181 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV LRTIs.

20. Number of infant participants with all-cause pneumonia [From birth to Day 181 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of all-cause pneumonia.

21. Time to first occurrence of severe and any medically assessed, RSV-associated LRTIs [From birth to Day 366 post birth]

    The vaccine arm will be compared to the placebo arm through the time to first occurrence of severe and any medically assessed, RSV-associated LRTIs.

22. Number of infant participants with RSV-associated hospitalizations [From birth to Day 366 post birth]

    The vaccine arm will be compared to the placebo arm through the occurrence of RSV associated hospitalizations.

23. Number of maternal participants with RSV-associated Medically Attended RTIs (RSV-MA-RTIs) [From Day 1 (vaccination) to Day 181 post delivery]

    The vaccine arm will be compared to the placebo arm through the occurrence of RSV-associated MA-RTIs.

24. Humoral immune response in terms of RSV MAT immunoglobulin G (IgG) antibody Geometric Mean Concentration (GMCs) in maternal participants, at specified timepoints [Day 1 (pre vaccination), Day 31 and at delivery]

    Serological assays for the determination of IgG antibodies against RSV MAT are performed by Enzyme-Linked Immunosorbent Assay (ELISA).

25. Humoral immune response in terms of RSV neutralizing antibody Geometric Mean Titers (GMTs) in maternal participants, at specified timepoints [At Day 1 (pre vaccination), Day 31 and at Delivery]

    Serological assays for the determination of antibodies against RSV-A and B are performed by neutralization assay.

26. Humoral immune response in terms of RSV MAT IgG antibody GMCs in infant participants, at specified timepoints [At birth, Day 43 post birth, Day 121 post birth and Day 181 post birth]

    Serological assays for the determination of IgG antibodies against RSV MAT are performed by ELISA.

27. Humoral immune response in terms of RSV neutralizing antibody GMTs in infant participants, at specified timepoints. [At birth, Day 43 post birth, Day 121 post birth and Day 181 post birth]

    Serological assays for the determination of antibodies against RSV-A and B are performed by neutralization assay.

28. Geometric mean ratio between cord blood and maternal RSV MAT IgG-specific antibody concentrations [At delivery or birth]

    Transfer of RSV-specific antibodies from maternal participants vaccinated with RSV Mat to their infants is calculated as the ratio between cord blood* and maternal RSV MAT IgG-specific antibody concentrations. * or an infant blood sample collected within 72 hours after birth (if no cord blood sample can be obtained)

29. Number of maternal participants with solicited adverse events (AEs) [From Day 1 to Day 7]

    Assessed solicited administration site events include pain, redness and swelling, at the injection site. Assessed solicited systemic events include fatigue, fever, nausea, vomiting, diarrhoea, abdominal pain and headache.

30. Number of maternal participants with unsolicited AEs [From Day 1 to Day 30]

    Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.

31. Number of maternal participants with at least one serious adverse event (SAE), AE leading to study termination or medically attended respiratory tract illness (MA-RTI) [From Day 1 (vaccination) to Month 6 post delivery]

    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. MA-RTI occurs when the maternal participant visits a healthcare professional (e.g., a General Practitioner) for any respiratory symptom, including (but not limited to) cough, sore throat, sputum production and difficulty breathing.

32. Number of maternal participants with at least one other medically attended AE [From Day 1 (vaccination) to Day 43 post delivery]

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

33. Number of maternal participants with each pregnancy outcome [From Day 1 to Day 43 post delivery]

    These pregnancy outcomes include live birth with no congenital anomalies, live birth with minor congenital anomaly(ies) only; live birth with at least one major congenital anomaly, fetal death/still birth (antepartum or intrapartum) with no congenital anomalies, fetal death/still birth (antepartum or intrapartum) with only minor congenital anomalies, fetal death/still birth (antepartum or intrapartum) with at least 1 major congenital anomaly; elective/therapeutic termination with no congenital anomalies; elective/therapeutic termination with only minor congenital anomalies, and elective/therapeutic termination with at least 1 major congenital anomaly.

34. Number of maternal participants with each pregnancy-related AE of special interest (AESI) [From Day 1 (vaccination) to Day 43 post delivery]

    These pregnancy-related AESIs include maternal death, hypertensive disorders of pregnancy, fetal growth restriction, pathways to preterm birth, gestational diabetes mellitus and chorioamnionitis. Worsening, post study vaccine administration, of pre-existing conditions already present at the time of enrolment. (e.g. controlled gestational hypertension or controlled gestational diabetes) are collected as (S)AEs and indicated as "worsening" or "aggravated". These are not to be considered as AESIs.

35. Number of infant participants with each neonatal AESI [From birth to Day 43 post birth]

    Neonatal AESIs include small for gestational age, low birth weight including very low and extremely low birth weight, congenital anomalies, neonatal death, preterm birth.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Maternal participants

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

• Participants who give written or witnessed/thumb printed informed consent after the study has been explained, and before any study specific procedures are performed, as per local regulations regulatory requirements.

• Age 18 to 49 years, inclusive, at the time of study intervention.

• Pre-pregnancy BMI 17.0 to 39.9 kg/m2, inclusive.

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

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

• At 24^{0/7 to 34}0/7 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) i.e. at or before 28 weeks of gestation.

• 1st or 2nd trimester U/S only, if LMP is unknown/uncertain

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

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

• No significant congenital malformations, as assessed by fetal anomaly ultrasound scan conducted at or beyond 18 weeks of gestation.

• Willing to provide cord blood.

• Who do not plan to give their child for adoption.

• Who plan to reside in the study area for at least one year after delivery.

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

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. OR, if permitted by local regulation, documented verbal consent for infant's participation obtained from the parent(s)/LAR(s) at birth, followed by written consent obtained by (or before) Visit 2-newborn.

Exclusion Criteria:

Maternal participants 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:

• Gestational hypertension unless blood pressure it is controlled and maintained in the normal range (<140mmHg and <90mmHg) through diet and/or antihypertensive medications

• Gestational diabetes 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 that can impair the maternal-fetal circulation

• Polyhydramnios

• Oligohydramnios

• Preterm labour or history of preterm labour in the current pregnancy

• Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery, including administration of systemic corticosteroids for fetal lung maturation

• Cholestasis

• Other pregnancy-related complications (per investigator's judgement)

• Significant structural abnormalities of the uterus or cervix

• History of 2 or more prior stillbirths or neonatal deaths/history of 2 or more preterm births at ≤34 weeks gestation/3 or more consecutive spontaneous abortions

• Known HIV infection (as per serological tests performed during the current pregnancy)

• Known or suspected HBV or HCV 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

• Known or suspected impairment of the immune system

• Current autoimmune disorder for which the participant has received immune-modifying therapy within 6 months before study vaccination, or plans administration through delivery

• Lymphoproliferative disorder or malignancy within 5 years before study vaccination

• Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions that might pose additional risk to the participant due to participation in the study

• Any conditions that may interfere with participant'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 an RSV vaccine in the current pregnancy

• Use of any investigational/non-registered product other than the study vaccine/product as described below, or planned use during the period :

• For a drug, vaccine or medical device: from 29 days before the dose of study vaccine

• For immunoglobulins: 3 months before the dose of study vaccine/product.

The exception to this is investigational products administered in the setting of a pandemic which may be allowed following delivery

• Planned administration/administration of any vaccine from 29 days before the dose of study vaccine or planned administration through delivery, except:

• Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines, dTpa/Tdap vaccines that also contain other antigens, Hepatitis B vaccines, and COVID-19 vaccines all of which may be administered according to standard of care ≥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

• Administration of immune-modifying therapy within 6 months before the study vaccination, 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; Inhaled, intra-articular/intra-bursal and topical steroids are allowed

• Corticosteroids administered for fetal lung maturation

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, in which the participant 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 DSM-5 criteria

• A local condition that precludes injection of the study vaccine/product or precludes assessment of local reactogenicity

• Consanguinity of maternal participant and her partner (second degree cousins or closer)

• Any study personnel or their immediate dependants, family or household members

Infant participants

• Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product

• Any condition which would increase the risks of study participation to the infant

• Child in care.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35205
2	GSK Investigational Site	Dothan	Alabama	United States	36301
3	GSK Investigational Site	Mobile	Alabama	United States	36608
4	GSK Investigational Site	Phoenix	Arizona	United States	85015
5	GSK Investigational Site	Tucson	Arizona	United States	85712
6	GSK Investigational Site	Burbank	California	United States	91506
7	GSK Investigational Site	Los Angeles	California	United States	90057
8	GSK Investigational Site	Miami	Florida	United States	33174
9	GSK Investigational Site	Blackfoot	Idaho	United States	83221
10	GSK Investigational Site	Idaho Falls	Idaho	United States	83404
11	GSK Investigational Site	Nampa	Idaho	United States	83686
12	GSK Investigational Site	Nampa	Idaho	United States	83687
13	GSK Investigational Site	Covington	Louisiana	United States	70433
14	GSK Investigational Site	Lafayette	Louisiana	United States	70508
15	GSK Investigational Site	Slidell	Louisiana	United States	70458
16	GSK Investigational Site	Detroit	Michigan	United States	48201
17	GSK Investigational Site	Saginaw	Michigan	United States	48604
18	GSK Investigational Site	Missoula	Montana	United States	59804
19	GSK Investigational Site	Grand Island	Nebraska	United States	68803
20	GSK Investigational Site	Lincoln	Nebraska	United States	68516
21	GSK Investigational Site	Norfolk	Nebraska	United States	68701
22	GSK Investigational Site	Albuquerque	New Mexico	United States	87102
23	GSK Investigational Site	Endwell	New York	United States	13760
24	GSK Investigational Site	Hendersonville	North Carolina	United States	28792
25	GSK Investigational Site	Englewood	Ohio	United States	45322
26	GSK Investigational Site	Greenville	South Carolina	United States	29607
27	GSK Investigational Site	Arlington	Texas	United States	75050
28	GSK Investigational Site	Austin	Texas	United States	78705
29	GSK Investigational Site	Burleson	Texas	United States	76028
30	GSK Investigational Site	Dallas	Texas	United States	75231
31	GSK Investigational Site	Fort Worth	Texas	United States	76104
32	GSK Investigational Site	Georgetown	Texas	United States	78626
33	GSK Investigational Site	Houston	Texas	United States	77008
34	GSK Investigational Site	Houston	Texas	United States	77058
35	GSK Investigational Site	Keller	Texas	United States	76248
36	GSK Investigational Site	Lampasas	Texas	United States	76550
37	GSK Investigational Site	League City	Texas	United States	77573
38	GSK Investigational Site	McAllen	Texas	United States	78503
39	GSK Investigational Site	Mesquite	Texas	United States	75149
40	GSK Investigational Site	Plano	Texas	United States	75093
41	GSK Investigational Site	Weatherford	Texas	United States	76086
42	GSK Investigational Site	Huntington	West Virginia	United States	25701
43	GSK Investigational Site	Caba	Buenos Aires	Argentina	1425
44	GSK Investigational Site	San Miguel de Tucumán	Tucumán	Argentina	T4000IHE
45	GSK Investigational Site	Buenos Aires		Argentina	C1141ACG
46	GSK Investigational Site	Buenos Aires		Argentina	C1425EFD
47	GSK Investigational Site	Rio Cuarto		Argentina	5800
48	GSK Investigational Site	South Brisbane	Queensland	Australia	4101
49	GSK Investigational Site	Southport	Queensland	Australia	4215
50	GSK Investigational Site	Geelong	Victoria	Australia	3220
51	GSK Investigational Site	Melbourne	Victoria	Australia	3168
52	GSK Investigational Site	Parkville	Victoria	Australia	3052
53	GSK Investigational Site	Nedlands	Western Australia	Australia	6009
54	GSK Investigational Site	Dhaka		Bangladesh
55	GSK Investigational Site	Sylhet		Bangladesh	3100
56	GSK Investigational Site	Genk		Belgium	3600
57	GSK Investigational Site	Gent		Belgium	9000
58	GSK Investigational Site	Kortrijk		Belgium	8500
59	GSK Investigational Site	Leuven		Belgium	3000
60	GSK Investigational Site	Sint-Niklaas		Belgium	9100
61	GSK Investigational Site	Caxias do Sul	Rio Grande Do Sul	Brazil	95070-560
62	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul	Brazil	90035001
63	GSK Investigational Site	Santa Maria	Rio Grande Do Sul	Brazil	97105-900
64	GSK Investigational Site	Ribeirão Preto	São Paulo	Brazil	14048-900
65	GSK Investigational Site	Alto Da Posse, Nova Iguacu		Brazil	26030-380
66	GSK Investigational Site	São José do Rio Preto		Brazil	15090-000
67	GSK Investigational Site	Winnipeg	Manitoba	Canada	R3A 1R9
68	GSK Investigational Site	Halifax	Nova Scotia	Canada	B3K 6R8
69	GSK Investigational Site	Truro	Nova Scotia	Canada	B2N 1L2
70	GSK Investigational Site	Kingston	Ontario	Canada	K7L 2V7
71	GSK Investigational Site	Montreal	Ontario	Canada	H3T 1C5
72	GSK Investigational Site	Québec		Canada	G1V 4G2
73	GSK Investigational Site	Barranquilla		Colombia	760002
74	GSK Investigational Site	Bogota		Colombia	110111
75	GSK Investigational Site	Cali		Colombia	760042
76	GSK Investigational Site	Chía		Colombia	250001
77	GSK Investigational Site	Medellin		Colombia	50042
78	GSK Investigational Site	Santo Domingo Este		Dominican Republic
79	GSK Investigational Site	Helsinki		Finland	00290
80	GSK Investigational Site	Kokkola		Finland	67100
81	GSK Investigational Site	Oulu		Finland	90220
82	GSK Investigational Site	Tampere		Finland	33100
83	GSK Investigational Site	Turku		Finland	20520
84	GSK Investigational Site	Bordeaux		France	33000
85	GSK Investigational Site	Bron		France	69677
86	GSK Investigational Site	Clermont Ferrand		France	63100
87	GSK Investigational Site	Epagny Metz-Tessy		France	74370
88	GSK Investigational Site	Montpellier cedex 5		France	34295
89	GSK Investigational Site	Paris		France	75679
90	GSK Investigational Site	Saint-Priest en Jarez		France	42270
91	GSK Investigational Site	Comayagua		Honduras
92	GSK Investigational Site	San Pedro Sula		Honduras	21101
93	GSK Investigational Site	Kanpur		India	208002
94	GSK Investigational Site	Kolkata		India	700017
95	GSK Investigational Site	Mangalore		India	575001
96	GSK Investigational Site	Mysuru		India	570015
97	GSK Investigational Site	Nagpur		India	441108
98	GSK Investigational Site	Pune		India	411043
99	GSK Investigational Site	Pune		India	412216
100	GSK Investigational Site	Milano	Lombardia	Italy	20122
101	GSK Investigational Site	Milano	Lombardia	Italy	20142
102	GSK Investigational Site	Milano	Lombardia	Italy	20154
103	GSK Investigational Site	Milano	Lombardia	Italy	20162
104	GSK Investigational Site	Novara	Piemonte	Italy	28100
105	GSK Investigational Site	Bari	Puglia	Italy	70124
106	GSK Investigational Site	Messina	Sicilia	Italy	98124
107	GSK Investigational Site	Palermo	Sicilia	Italy	90127
108	GSK Investigational Site	Prato	Toscana	Italy	59100
109	GSK Investigational Site	Verona		Italy	37126
110	GSK Investigational Site	Daegu-si		Korea, Republic of	42601
111	GSK Investigational Site	Seoul		Korea, Republic of	08308
112	GSK Investigational Site	Seoul		Korea, Republic of	3080
113	GSK Investigational Site	Morelia	Michoacán	Mexico	58260
114	GSK Investigational Site	Monterrey	Nuevo León	Mexico	64460
115	GSK Investigational Site	Monterrey	Nuevo León	Mexico	64570
116	GSK Investigational Site	San Juan del Río	Querétaro	Mexico	76800
117	GSK Investigational Site	Chihuahua		Mexico	31000
118	GSK Investigational Site	Oaxaca		Mexico	68000
119	GSK Investigational Site	San Luis Potosí		Mexico	78200
120	GSK Investigational Site	Auckland		New Zealand	1010
121	GSK Investigational Site	Auckland		New Zealand	1701
122	GSK Investigational Site	Newtown		New Zealand	6021
123	GSK Investigational Site	Panama City		Panama	32401
124	GSK Investigational Site	Panama		Panama	0801
125	GSK Investigational Site	Panama		Panama	1001
126	GSK Investigational Site	Panama		Panama	7096
127	GSK Investigational Site	Dasmariñas, Cavite		Philippines	4114
128	GSK Investigational Site	Manila		Philippines	1000
129	GSK Investigational Site	Manila		Philippines	1008
130	GSK Investigational Site	Coronationville	Gauteng	South Africa	2112
131	GSK Investigational Site	Johannesburg		South Africa	2117
132	GSK Investigational Site	Mamelodi East		South Africa	122
133	GSK Investigational Site	Soshanguve		South Africa	0152
134	GSK Investigational Site	Malaga	Andalucia	Spain	29004
135	GSK Investigational Site	Santiago De Compostela	Galicia	Spain	15706
136	GSK Investigational Site	Collado Villalba	Madrid	Spain	28400
137	GSK Investigational Site	Aravaca		Spain	28023
138	GSK Investigational Site	Barcelona		Spain	08028
139	GSK Investigational Site	Barcelona		Spain	08035
140	GSK Investigational Site	Barcelona		Spain	08950
141	GSK Investigational Site	Basurto/Bilbao		Spain	48013
142	GSK Investigational Site	Boadilla del Monte		Spain	28660
143	GSK Investigational Site	Burgos		Spain	09006
144	GSK Investigational Site	Gandía (Valencia)		Spain	46702
145	GSK Investigational Site	Getafe/Madrid		Spain	28905
146	GSK Investigational Site	Madrid		Spain	28007
147	GSK Investigational Site	Madrid		Spain	28041
148	GSK Investigational Site	Madrid		Spain	28046
149	GSK Investigational Site	Majadahonda (Madrid)		Spain	28222
150	GSK Investigational Site	Malaga		Spain	29010
151	GSK Investigational Site	Marbella		Spain	29603
152	GSK Investigational Site	Sevilla		Spain	41013
153	GSK Investigational Site	Sevilla		Spain	41014
154	GSK Investigational Site	Torrejón Ardoz		Spain	28850
155	GSK Investigational Site	Valencia		Spain	46017
156	GSK Investigational Site	Valladolid		Spain	47012
157	GSK Investigational Site	Changhua		Taiwan	500
158	GSK Investigational Site	Kaohsiung City		Taiwan	833
159	GSK Investigational Site	Taichung		Taiwan	40447
160	GSK Investigational Site	Taipei City		Taiwan	10449
161	GSK Investigational Site	Taipei		Taiwan	0105
162	GSK Investigational Site	Taipei		Taiwan	10041
163	GSK Investigational Site	Taoyuan		Taiwan	333
164	GSK Investigational Site	Bangkok		Thailand	10330
165	GSK Investigational Site	Muang		Thailand	50200
166	GSK Investigational Site	Edinburgh		United Kingdom	EH16 4SA
167	GSK Investigational Site	Nottingham		United Kingdom	NG7 2UH

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04605159
• Other Study ID Numbers: 212171; 2020-001355-40
• First Posted: Oct 27, 2020
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Jul 28, 2022