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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04032093




Registration number
NCT04032093
Ethics application status
Date submitted
22/07/2019
Date registered
25/07/2019
Date last updated
10/08/2020

Titles & IDs
Public title
A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
Scientific title
A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS
Secondary ID [1] 0 0
C3671003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infection 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 vaccine
Other interventions - Placebo

Experimental: RSV dose with aluminum hydroxide - RSV vaccine with aluminum hydroxide

Experimental: RSV dose without aluminum hydroxide - RSV vaccine without aluminum hydroxide

Experimental: Higher RSV dose with aluminum hydroxide - Higher dose level RSV vaccine with aluminum hydroxide

Experimental: Higher RSV dose without aluminum hydroxide - Higher dose level RSV vaccine without aluminum hydroxide

Placebo Comparator: Placebo dose - Normal saline solution for injection (0.9% sodium chloride injection)


Other interventions: RSV vaccine
RSV vaccine

Other interventions: Placebo
Normal saline solution for injection (0.9% sodium chloride injection)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7 - Describe local reactions and systemic events after 1 dose of investigational product
Timepoint [1] 0 0
From day of vaccination until 7 days after vaccination
Primary outcome [2] 0 0
Percentage of participants reporting Adverse Events (AE) within 1 month after vaccination - Describe adverse events (AE) after vaccination
Timepoint [2] 0 0
Within 1 month after vaccination
Primary outcome [3] 0 0
Percentage of participants reporting obstetric complications, medically attended adverse events (MAE) and serious adverse events (SAE) throughout the study - Describe obstetric complications, MAE and SAE throughout the study
Timepoint [3] 0 0
Up to 12 months after vaccination
Primary outcome [4] 0 0
The percentage of infant participants with specific birth outcomes - Describe specific birth outcomes for infant participants
Timepoint [4] 0 0
Birth
Primary outcome [5] 0 0
The percentage of infant participants with AE from birth to 1 month of age - Describe AE for infant participants from birth to 1 month of age
Timepoint [5] 0 0
Up to 1 month of age
Primary outcome [6] 0 0
The percentage of infant participants with SAE, AE of special interest (congenital anomalies, developmental delay), and MAE through 12 months of age - Describe SAE, AE of special interest (congenital anomalies, developmental delay), and MAE for infant participants through 12 months of age
Timepoint [6] 0 0
Through 12 months of age
Secondary outcome [1] 0 0
Immune responses measured by RSV neutralizing antibody titers in maternal participants - Immune responses measured by RSV neutralizing antibody titers at specified timepoints in maternal participants
Timepoint [1] 0 0
Baseline (pre-vaccination) and 2 weeks and 1 month after vaccination and at delivery
Secondary outcome [2] 0 0
Geometric mean ratio (GMR) for RSV neutralizing antibody titers in maternal participants - GMR estimated by the ratio of the geometric mean titers (GMT) for RSV neutralizing antibody titers of the RSV vaccine group and the placebo group in maternal participants
Timepoint [2] 0 0
Baseline (pre-vaccination) and 2 weeks and 1 month after vaccination and at delivery
Secondary outcome [3] 0 0
Functional antibody levels estimated by the GMT for RSV neutralizing antibody titers in infant participants - Charateristics of transplacentally transferred antibody measured by RSV neutralizing antibody titers at specified timepoints in infant participants
Timepoint [3] 0 0
Birth and two time points between 1 and 6 months of age
Secondary outcome [4] 0 0
GMR for RSV neutralizing antibody titers in infant participants - GMR estimated by the ratio of the geometric mean titers (GMT) for RSV neutralizing antibody titers of the RSV vaccine group and the placebo group in infant participants
Timepoint [4] 0 0
Birth and two time points between 1 and 6 months of age

Eligibility
Key inclusion criteria
Inclusion Criteria - Maternal participants:

- Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of
planned vaccination, with an uncomplicated pregnancy, who are at no known increased
risk for complications, and whose fetus has no significant abnormalities observed on
ultrasound.

- Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.

- Receiving prenatal standard of care.

- Had an ultrasound performed at >=18 weeks of pregnancy.

- Had a negative urinalysis for protein and glucose at the screening visit. Trace
protein in the urine is acceptable if the blood pressure is also normal.

- Determined by medical history, physical examination, screening laboratory assessment,
and clinical judgment to be appropriate for inclusion in the study.

- Documented negative human immunodeficiency virus antibody, hepatitis B virus surface
antigen, hepatitis C virus antibody, and syphilis tests at the screening visit.

- Body mass index of </=40 kg/m2 at the time of the screening visit.

- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent document and in this
protocol.

- Expected to be available for the duration of the study and willing to give informed
consent for her infant to participate in the study.

Inclusion Criteria - Infant Participants:

- Evidence of a signed and dated ICD signed by the parent(s).

- Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures.
Minimum age
18 Years
Maximum age
49 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria - Maternal Participants:

- Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.

- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction to any component of the investigational product or any related vaccine.

- History of latex allergy.

- History of any severe allergic reaction.

- Participants with known or suspected immunodeficiency.

- Current pregnancy resulting from in vitro fertilization or other assisted reproductive
technology.

- A prior history of or known current pregnancy complications or abnormalities that will
increase the risk associated with the participant's participation in and completion of
the study.

- Major illness of the mother or conditions of the fetus that, in the investigator's
judgment, will substantially increase the risk associated with the participant's
participation in, and completion of, the study or could preclude the evaluation of the
participant's response.

- Participant with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention including but not limited to systemic or cutaneous
lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré
syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura,
glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis),
psoriasis, and insulin-dependent diabetes mellitus (type 1).

- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.

- Participation in other studies involving investigational drug(s) within 28 days prior
to study entry and/or during study participation.

- Participants who receive treatment with immunosuppressive therapy including cytotoxic
agents or systemic corticosteroids (such as for cancer or an autoimmune disease), or
planned receipt of such treatment or agents during study participation. If systemic
corticosteroids have been administered short term (<14 days) for treatment of an acute
illness, participants should not be enrolled into the study until corticosteroid
therapy has been discontinued for at least 30 days before investigational product
administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or
eyes) corticosteroids are permitted.

- Current alcohol abuse or illicit drug use.

- Receipt of blood or plasma products or immunoglobulin, from 60 days before
investigational product administration, or planned receipt through delivery, with 1
exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.

- Previous vaccination with any licensed or investigational RSV vaccine or planned
receipt during study participation.

- Laboratory test results at the screening visit outside the normal reference value for
pregnant women according to their trimester in pregnancy.

- Participants who are breastfeeding at the time of the screening visit.

Exclusion Criteria - Infant Participants:

• Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Telethon Kids Institute, Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
West Virginia
Country [26] 0 0
Argentina
State/province [26] 0 0
Tucuman
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autonoma de Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordoba
Country [29] 0 0
Argentina
State/province [29] 0 0
Salta
Country [30] 0 0
Chile
State/province [30] 0 0
Region Metropolitana
Country [31] 0 0
Chile
State/province [31] 0 0
Región DE LOS Lagos
Country [32] 0 0
Chile
State/province [32] 0 0
Región Metropolitana
Country [33] 0 0
New Zealand
State/province [33] 0 0
Christchurch
Country [34] 0 0
New Zealand
State/province [34] 0 0
Wellington
Country [35] 0 0
South Africa
State/province [35] 0 0
Gauteng

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

Ethics approval
Ethics application status

Summary
Brief summary
This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV
vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine,
formulated with or without aluminum hydroxide, or placebo, and investigate safety and
characteristics of antibodies in their infants.
Trial website
https://clinicaltrials.gov/show/NCT04032093
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04032093