A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN

Phase 2

Completed

Conditions: Respiratory Tract Infection

Registration Number: NCT04032093

Lead Sponsor: Pfizer

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.

Detailed Description: This Phase 2b, multicenter, randomized, placebo-controlled study will evaluate the safety, tolerability, and immunogenicity of a respiratory syncytial virus stabilized prefusion F subunit vaccine (RSV vaccine) in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, as well as assess safety and characteristics of transplacentally transferred antibodies in their infants.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1153

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination	Within 1 month after vaccination	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Percentage of Infant Participants With Specific Birth Complications	At birth	Specific birth complications included clavicle fracture, torticollis, cephalhematoma, premature baby, acute respiratory failure, meconium aspiration syndrome, neonatal pneumothorax, neonatal respiratory depression, neonatal respiratory distress, neonatal respiratory distress syndrome, neonatal respiratory failure, pneumothorax, respiratory distress, transient tachypnea of the newborn and subgaleal hemorrhage. Percentage of participants with any specific birth complications were reported in this outcome measure.
Percentage of Infant Participants With Any AE Within 1 Month of Age	Within 1 month after birth	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay	Within 12 months after birth	AEs of special interest for infant participants included congenital anomalies and developmental delays. Congenital anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Severity was assessed based on the study investigator's judgement and graded as grade 1= mild (does not interfere with participant's usual function); grade 2= moderate (interferes to some extent with participant's usual function); grade 3= severe (interferes significantly with participant's usual function) and grade 4= life-threatening (life-threatening consequences; urgent intervention indicated). Percentage of infant participants with AEs of special interest of at least moderate severity were presented.
Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications	From day of vaccination (Day 1) up to 12 months post-delivery	MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Obstetric complications were determined as per the study clinician's judgement.
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination	Within 7 days after vaccination	Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination.
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination	Within 7 days after vaccination	Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was categorized as: grade 1: mild (\>=38.0 to 38.4 degrees \[deg\] Celsius \[C\]), grade 2: moderate (\>38.4 to 38.9 deg C), grade 3: severe (\>38.9 to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination.
Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age	Within 12 months after birth	MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants	At birth and at 1, 2, 4, 6 months after birth	GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student t distribution. GMRs of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants	Before vaccination, 2 weeks and 1 month after vaccination and at delivery	GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. Geometric mean ratios (GMRs) of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants	2 weeks and 1 month after vaccination, at delivery	GMFRs for RSV A and RSV B neutralizing antibody titers from before vaccination to each available time point after vaccination were calculated by exponentiating the mean logarithm of the fold rises. Corresponding 95% CI was based on the Student t distribution. Data for this outcome measure was planned to be analyzed for maternal participants only.

Trial Locations

Locations (148): Children's of Alabama
🇺🇸
Birmingham, Alabama, United States
UAB Women & Infants Center - UAB Medicine
🇺🇸
Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Cullman Clinical Research, Inc
🇺🇸
Cullman, Alabama, United States
Cullman Primary Care, PC
🇺🇸
Cullman, Alabama, United States
Cullman Regional
🇺🇸
Cullman, Alabama, United States
Arrowhead Hospital
🇺🇸
Glendale, Arizona, United States
Abrazo West Campus Hospital
🇺🇸
Goodyear, Arizona, United States
St. Joseph Hospital
🇺🇸
Phoenix, Arizona, United States
MedPharmics, LLC
🇺🇸
Gulfport, Mississippi, United States
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Children's of Alabama
🇺🇸Birmingham, Alabama, United States