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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04032093
Ethics application status
Date submitted
22/07/2019
Date registered
25/07/2019
Date last updated
18/10/2022

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
Treatment: Other - RSV vaccine
Treatment: Other - 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)


Treatment: Other: RSV vaccine
RSV vaccine

Treatment: Other: Placebo
Normal saline solution for injection (0.9% sodium chloride injection)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Timepoint [1] 0 0
Within 7 days after vaccination
Primary outcome [2] 0 0
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Timepoint [2] 0 0
Within 7 days after vaccination
Primary outcome [3] 0 0
Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Timepoint [3] 0 0
Within 1 month after vaccination
Primary outcome [4] 0 0
Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications
Timepoint [4] 0 0
From day of vaccination (Day 1) up to 12 months post-delivery
Primary outcome [5] 0 0
Percentage of Infant Participants With Specific Birth Complications
Timepoint [5] 0 0
At birth
Primary outcome [6] 0 0
Percentage of Infant Participants With Any AE Within 1 Month of Age
Timepoint [6] 0 0
Within 1 month after birth
Primary outcome [7] 0 0
Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age
Timepoint [7] 0 0
Within 12 months after birth
Primary outcome [8] 0 0
Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay
Timepoint [8] 0 0
Within 12 months after birth
Secondary outcome [1] 0 0
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
Timepoint [1] 0 0
Before vaccination, 2 weeks and 1 month after vaccination and at delivery
Secondary outcome [2] 0 0
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
Timepoint [2] 0 0
2 weeks and 1 month after vaccination, at delivery
Secondary outcome [3] 0 0
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
Timepoint [3] 0 0
At birth and at 1, 2, 4, 6 months after birth

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2021
Sample size
Target
Accrual to date
Final
1153
Recruitment in Australia
Recruitment state(s)
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
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
West Virginia
Country [24] 0 0
Argentina
State/province [24] 0 0
Tucuman
Country [25] 0 0
Chile
State/province [25] 0 0
Region Metropolitana
Country [26] 0 0
Chile
State/province [26] 0 0
Región DE LOS Lagos
Country [27] 0 0
Chile
State/province [27] 0 0
Región Metropolitana
Country [28] 0 0
Chile
State/province [28] 0 0
RM
Country [29] 0 0
New Zealand
State/province [29] 0 0
Christchurch
Country [30] 0 0
South Africa
State/province [30] 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/study/NCT04032093
Trial related presentations / publications
Simoes EAF, Center KJ, Tita ATN, Swanson KA, Radley D, Houghton J, McGrory SB, Gomme E, Anderson M, Roberts JP, Scott DA, Jansen KU, Gruber WC, Dormitzer PR, Gurtman AC. Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy. N Engl J Med. 2022 Apr 28;386(17):1615-1626. doi: 10.1056/NEJMoa2106062.
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
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/study/NCT04032093