A Phase III double-blind study to assess safety andefficacy of an RSV Maternal unadjuvanted vaccine,in pregnant women and infants born to vaccinatedmothers

PHRR210215-003342

212171

2020-CT0584

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 LRTI in their infants up to 6 months of age

GSK is developing an investigational Respiratory Syncytial Virus (RSV) vaccine for
administration to pregnant women, with the aim of preventing medically assessed, RSV-associated
lower respiratory tract illnesses (LRTIs) in their infants by transfer of maternal
antibodies. The vaccine candidate is an engineered version of the RSV fusion (F) surface
glycoprotein, stabilized in the pre-fusion conformation.

Ongoing

Respiratory Syncytial Virus (RSV)-associated Lower Respiratory Tract Illness (LRTI)

From birth (Visit 1-NB) to 6 months (Visit 4-NB), occurrences
of medically assessed, RSV-associated severe (including
very severe) LRTIs according to the case definitions.

or

From birth (Visit 1-NB) to 6 months (Visit 4-NB), occurrences
of any medically assessed, RSV-associated LRTIs
according to the case definitions.

* From birth (Visit 1-NB) to 6 months (Visit 4-NB), occurrences
of RSV-associated hospitalizations according to the case
definitions

* From birth (Visit 1-NB) to 6 months (Visit 4-NB), occurrences
of all-cause LRTI

* From birth (Visit 1-NB) to 6 months (Visit 4-NB), occurrences
of all-cause LRTI with hospitalization

* From birth (Visit 1-NB) to 7 months, birth to 8 months, and
birth to 9 months (C2-NB), occurrences of medically
assessed, RSV-associated severe (including very severe)
LRTIs according to the case definitions

* From birth (Visit 1-NB) to 7 months, birth to 8 months, and
birth to 9 months (C2-NB), occurrences of any medically
assessed, RSV-associated LRTIs according to the case
definitions

Pending

• Argentina
• Australia
• Bangladesh
• Belgium
• Brazil
• Canada
• Colombia
• Finland
• France
• India
• Italy
• Mexico
• New Zealand
• Panama
• Philippines
• Russia
• South Africa
• South Korea
• Spain
• Taiwan
• Thailand
• United Kingdom
• United States

Clinical Trial

20201204090715

2021-02-01

0000-00-00

319

Unspecified

Unspecified

05 Apr 2021

Maternal participants must satisfy all the following criteria at study entry:
• Participants who, in the opinion of the investigator, can and will comply with the
requirements of the protocol (e.g. completion of diaries, return for follow-up visits).
• Participants 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 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.
• Age 18 to 49 years, inclusive, at the time of study intervention.
• Pre-pregnancy BMI (based on participant’s report) 18.5 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.
NOTES: If pregnancy resulted from assisted reproductive technologies, LMP date
may be replaced by IUI (intrauterine insemination) or ET (embryo-transfer) date).
If LMP (or IUI or ET) and U/S performed before 28weeks of gestation, do not
correlate, default to U/S gestational age assessment.
If the first U/S is only performed after 28 weeks of gestation (i.e. 3rd trimester) and
there is no other basis for estimating gestational age, or the only other basis is fundal
height, then the GA calculation is uncertain and the woman should be excluded.
The level of diagnostic certainty of the gestational age should be established by using
the Global Alignment of Immunisation safety Assessment in pregnancy (GAIA)
gestation age assessment tool (Section 10.8).
• No fetal genetic abnormalities (based on genetic testing, if performed).
• No significant congenital malformations (such as abnormal fetal morphology,
abnormal amniotic fluid levels, significant abnormalities in placenta or umbilical
cord), as assessed by fetal anomaly ultrasound scan (also known as a level 2
ultrasound or fetal morphology assessment) 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.
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 must satisfy all the following criteria at study entry:
• 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 with RTI surveillance and other protocolrequired
procedures that begin immediately after birth: If written consent cannot be
provided by the parent(s)/LAR(s) readily post-birth, verbal consent – if permitted per
local regulation -- may be sought from the parent(s) / LAR(s) instead. Verbal consent
should be documented in the source data by the investigator or delegate. The
parent(s) / LAR(s) will provide additional, written informed consent by (or before)
Visit 2-NB.

Interventional

GlaxoSmithKline (GSK) Respiratory Syncytial Virus (RSV) Maternal (RSVPreF3) Vaccine (GSK3888550A)

RSVPreF3 (CHO rDNA) VACCINE - LYOPHILIZED - 120 μg per dose of RSVPreF3 unadjuvanted vaccine

None

Randomized

Double Blind

To minimize the introduction of bias, this study will be double-blinded. Participants willnot have access to their randomization assignment, and investigators and their staff willbe blinded to the participant’s assigned study intervention throughout the course of thestudy.

Single

To assess the efficacy of a single dose of the
RSV Maternal vaccine administered to maternal
participants in preventing medically assessed1,
RSV-associated severe (including very severe)
LRTIs in their infant5 participants up to 6 months
of age

or

To assess the efficacy of a single dose of the
RSV Maternal vaccine administered to maternal
participants in preventing medically assessed1,
RSV-associated LRTIs of any severity in their
infant5 participants up to 6 months of age

Phase III