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NCT04071158

A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS

Completed Phase 2 Results posted Last updated 15 February 2021
What this trial tests

Phase 2 trial testing RSV Vaccine in Respiratory Tract Infection in 713 participants. Completed in 11 December 2019.

Timeline
1 October 2019
Primary endpoint
11 December 2019
11 December 2019

Quick facts

Lead sponsorPfizer
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment713
Start date1 October 2019
Primary completion11 December 2019
Estimated completion11 December 2019
Sites16 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 49, female only, with Respiratory Tract Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Achieving Anti-Tetanus Toxoid (TTd) Antibody Concentrations of Greater Than or Equal to (>=) 0.1 International Units Per Milliliter (IU/mL) at 1 Month After Vaccination Primary · 1 month after vaccination

Percentage of participants achieving Anti-TTd antibody concentrations of \>= 0.1 IU/mL at 1 month after vaccination were reported. The lower limit of quantitation (LLOQ) values for Anti-TTd was 0.05 IU/mL. Assay results below the LLOQ were set to 0.5\*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV

GroupValue95% CI
RSV Vaccine With Aluminum Hydroxide With Tdap10098.7 – 100.0
Placebo/Tdap10097.3 – 100.0
Percentage of Participants Achieving Anti-Diphtheria Toxoid (DTd) Antibody Concentrations of >= 0.1 IU/mL at 1 Month After Vaccination Primary · 1 month after vaccination

Percentage of participants achieving Anti-DTd antibody concentrations of \>= 0.1 IU/mL at 1 month after vaccination were reported. The LLOQ values for Anti- DTd= 0.037 IU/mL. Assay results below the LLOQ were set to 0.5\*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo an

GroupValue95% CI
RSV Vaccine With Aluminum Hydroxide With Tdap97.494.8 – 99.0
Placebo/Tdap99.395.9 – 100.0
Geometric Mean Concentration (GMC) and Geometric Mean Ratio (GMR) of Anti-Pertussis Antibodies 1 Month After Vaccination Primary · 1 month after vaccination

GMCs of anti-pertussis components: anti pertussis (anti-PT) toxin, anti filamentous hemagglutinin (FHA) and anti- pertactin (PRN) was measured and reported in descriptive section. LLOQ values for each component was: Anti-PT=0.9 endotoxin units per milliliter (EU/mL), Anti-FHA=2.9 EU/mL, and Anti-PRN=3.0 EU/mL. Assay results below LLOQ were set to 0.5\*LLOQ. Descriptive data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydrox

Anti-PT
GroupValue95% CI
RSV Vaccine With Aluminum Hydroxide With Tdap36.5933.10 – 40.46
Placebo/Tdap45.9037.43 – 56.29
Anti-FHA
GroupValue95% CI
RSV Vaccine With Aluminum Hydroxide With Tdap113.30104.13 – 123.28
Placebo/Tdap191.33164.46 – 222.59
Anti-PRN
GroupValue95% CI
RSV Vaccine With Aluminum Hydroxide With Tdap154.13135.98 – 174.70
Placebo/Tdap257.05211.55 – 312.34
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin Primary · 1 month after vaccination

Assay results below the LLOQ were set to 0.5\*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in stat

GroupValue95% CI
RSV Vaccine With Aluminum Hydroxide With Tdap22339.020362.3 – 24507.6
RSV Vaccine With Aluminum Hydroxide With Placebo22980.120371.3 – 25922.9
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin Primary · 1 month after vaccination

Assay results below the LLOQ were set to 0.5\*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in stat

GroupValue95% CI
RSV Vaccine With Aluminum Hydroxide With Tdap21509.719279.4 – 23997.9
RSV Vaccine With Aluminum Hydroxide With Placebo22486.019696.2 – 25671.0
Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination Primary · Within 7 days after vaccination

Local reactions included pain at injection site, redness and swelling 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.

Pain at injection site: mild
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo33.325.6 – 41.8
RSV Vaccine 120 mcg With Tdap34.026.3 – 42.5
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo46.137.7 – 54.7
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap46.938.5 – 55.4
Placebo/Tdap21.615.1 – 29.4
Pain at injection site: moderate
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo7.13.5 – 12.7
RSV Vaccine 120 mcg With Tdap9.95.5 – 16.1
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo19.913.6 – 27.4
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap15.49.9 – 22.4
Placebo/Tdap4.31.6 – 9.2
Pain at injection site: severe
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo00.0 – 2.6
RSV Vaccine 120 mcg With Tdap0.70.0 – 3.9
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo0.70.0 – 3.9
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap00.0 – 2.5
Placebo/Tdap00.0 – 2.6
Redness: mild
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo6.43.0 – 11.8
RSV Vaccine 120 mcg With Tdap3.51.2 – 8.1
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo4.31.6 – 9.0
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap2.80.8 – 7.0
Placebo/Tdap0.70.0 – 3.9
Redness: moderate
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo0.70.0 – 3.9
RSV Vaccine 120 mcg With Tdap0.70.0 – 3.9
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo0.70.0 – 3.9
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap2.80.8 – 7.0
Placebo/Tdap00.0 – 2.6
Redness: severe
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo00.0 – 2.6
RSV Vaccine 120 mcg With Tdap00.0 – 2.6
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo00.0 – 2.6
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap00.0 – 2.5
Placebo/Tdap00.0 – 2.6
Swelling: mild
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo4.31.6 – 9.0
RSV Vaccine 120 mcg With Tdap4.31.6 – 9.0
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo2.10.4 – 6.1
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap3.51.1 – 8.0
Placebo/Tdap0.70.0 – 3.9
Swelling: moderate
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo2.80.8 – 7.1
RSV Vaccine 120 mcg With Tdap1.40.2 – 5.0
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo2.10.4 – 6.1
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap3.51.1 – 8.0
Placebo/Tdap0.70.0 – 3.9
Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination Primary · Within 7 days after vaccination

Systemic reactions included fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C 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

Fever: >=38.0 degree C
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo7.84.0 – 13.5
RSV Vaccine 120 mcg With Tdap6.43.0 – 11.8
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo6.43.0 – 11.8
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap7.73.9 – 13.3
Placebo/Tdap5.02.0 – 10.1
Fever: mild
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo4.31.6 – 9.0
RSV Vaccine 120 mcg With Tdap3.51.2 – 8.1
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo5.72.5 – 10.9
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap2.80.8 – 7.0
Placebo/Tdap3.61.2 – 8.2
Fever: moderate
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo2.10.4 – 6.1
RSV Vaccine 120 mcg With Tdap1.40.2 – 5.0
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo0.70.0 – 3.9
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap3.51.1 – 8.0
Placebo/Tdap0.70.0 – 3.9
Fever: severe
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo1.40.2 – 5.0
RSV Vaccine 120 mcg With Tdap00.0 – 2.6
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo00.0 – 2.6
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap1.40.2 – 5.0
Placebo/Tdap00.0 – 2.6
Fever: Grade 4
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo00.0 – 2.6
RSV Vaccine 120 mcg With Tdap1.40.2 – 5.0
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo00.0 – 2.6
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap00.0 – 2.5
Placebo/Tdap0.70.0 – 3.9
Fatigue: mild
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo20.614.2 – 28.2
RSV Vaccine 120 mcg With Tdap24.117.3 – 32.0
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo21.314.8 – 29.0
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap23.116.4 – 30.9
Placebo/Tdap26.619.5 – 34.8
Fatigue: moderate
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo19.113.0 – 26.6
RSV Vaccine 120 mcg With Tdap22.015.5 – 29.7
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo22.716.1 – 30.5
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap22.415.8 – 30.1
Placebo/Tdap17.311.4 – 24.6
Fatigue: severe
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo2.80.8 – 7.1
RSV Vaccine 120 mcg With Tdap2.10.4 – 6.1
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo0.70.0 – 3.9
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap1.40.2 – 5.0
Placebo/Tdap00.0 – 2.6
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination Primary · Within 1 month after vaccination (up to 35 days)

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.

GroupValue95% CI
RSV Vaccine 120 mcg With Placebo5.72.5 – 10.9
RSV Vaccine 120 mcg With Tdap7.84.0 – 13.5
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo5.62.5 – 10.8
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap10.45.9 – 16.6
Placebo/Tdap9.25.0 – 15.3
Percentage of Participants With Medically Attended Adverse Events (MAE) and Serious Adverse Events (SAE) Primary · Within 1 month after vaccination (up to 35 days)

An medically attended adverse events (MAE) was defined as a non-serious AE that results in an evaluation at a medical facility. 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.

SAE
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo00.0 – 2.6
RSV Vaccine 120 mcg With Tdap00.0 – 2.6
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo0.70.0 – 3.9
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap00.0 – 2.5
Placebo/Tdap00.0 – 2.6
MAE
GroupValue95% CI
RSV Vaccine 120 mcg With Placebo1.40.2 – 5.0
RSV Vaccine 120 mcg With Tdap00.0 – 2.6
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo00.0 – 2.6
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap1.40.2 – 4.9
Placebo/Tdap2.10.4 – 6.1
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin Secondary · 1 month after vaccination

Assay results below the LLOQ were set to 0.5\*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in stat

GroupValue95% CI
RSV Vaccine With Aluminum Hydroxide With Tdap22339.020362.3 – 24507.6
RSV Vaccine With Aluminum Hydroxide With Placebo22980.120371.3 – 25922.9
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin Secondary · 1 month after vaccination

Assay results below the LLOQ were set to 0.5\*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in stat

GroupValue95% CI
RSV Vaccine With Aluminum Hydroxide With Tdap21509.719279.4 – 23997.9
RSV Vaccine With Aluminum Hydroxide With Placebo22486.019696.2 – 25671.0
Percentage of Participants Achieving Anti-TTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination Secondary · Before vaccination on Day 1

Percentage of participants achieving Anti-TTd antibody concentrations of \>= 0.1 IU/mL 1 month before vaccination were reported. The LLOQ values for Anti-TTd = 0.05 IU/mL. Assay results below the LLOQ were set to 0.5\*LLOQ. Data for this outcome measure was not planned to be collected and analyzed for RSV 120 mcg with placebo arm and RSV 240 mcg with aluminum hydroxide/placebo arm.

GroupValue95% CI
RSV Vaccine 120 mcg With Tdap97.893.6 – 99.5
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap96.491.7 – 98.8
Placebo/Tdap99.395.9 – 100.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RSV Vaccine 120 mcg With Placebo
Serious: 0/141 (0%)
Deaths: 0/141
RSV Vaccine 120 mcg With Tdap
Serious: 0/141 (0%)
Deaths: 0/141
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo
Serious: 1/142 (1%)
Deaths: 0/142
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap
Serious: 0/144 (0%)
Deaths: 0/144
Placebo/Tdap
Serious: 0/141 (0%)
Deaths: 0/141

Serious adverse events (1 terms)

ReactionSystemRSV Vaccine 120 mcg With P…RSV Vaccine 120 mcg With T…RSV Vaccine 240 mcg With A…RSV Vaccine 240 mcg With A…Placebo/Tdap
Abortion spontaneousPregnancy, puerperium and perinatal conditions—————
Other adverse events (56 terms — click to expand)

ReactionSystemRSV Vaccine 120 mcg With P…RSV Vaccine 120 mcg With T…RSV Vaccine 240 mcg With A…RSV Vaccine 240 mcg With A…Placebo/Tdap
Injection site painGeneral disorders—————
MyalgiaMusculoskeletal and connective tissue disorders—————
FatigueGeneral disorders—————
HeadacheNervous system disorders—————
NauseaGastrointestinal disorders—————
DiarrhoeaGastrointestinal disorders—————
ArthralgiaMusculoskeletal and connective tissue disorders—————
PyrexiaGeneral disorders—————
Injection site erythemaGeneral disorders—————
Injection site swellingGeneral disorders—————
VomitingGastrointestinal disorders—————
Upper respiratory tract infectionInfections and infestations—————
FatigueGeneral disorders—————
NasopharyngitisInfections and infestations—————
HeadacheNervous system disorders—————
MigraineNervous system disorders—————
Oropharyngeal painRespiratory, thoracic and mediastinal disorders—————
LymphadenopathyBlood and lymphatic system disorders—————
HypothyroidismEndocrine disorders—————
Abdominal pain upperGastrointestinal disorders—————
ConstipationGastrointestinal disorders—————
DiarrhoeaGastrointestinal disorders—————
HaemorrhoidsGastrointestinal disorders—————
NauseaGastrointestinal disorders—————
Tooth impactedGastrointestinal disorders—————
ToothacheGastrointestinal disorders—————
Axillary painGeneral disorders—————
Injection site painGeneral disorders—————
SwellingGeneral disorders—————
Cholecystitis acuteHepatobiliary disorders—————
Seasonal allergyImmune system disorders—————
Bacterial vaginosisInfections and infestations—————
Oral herpesInfections and infestations—————
Ear infectionInfections and infestations—————
Pharyngitis streptococcalInfections and infestations—————
Sinusitis bacterialInfections and infestations—————
SinusitisInfections and infestations—————
TonsillitisInfections and infestations—————
Tooth infectionInfections and infestations—————
Urinary tract infectionInfections and infestations—————

Most-reported serious reactions: Abortion spontaneous.

Data from ClinicalTrials.gov NCT04071158 adverse events section.

Sponsor's own description

This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. This study will evaluate non-inferiority of RSV vaccine when given with Tdap and vice-versa.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscape.
    Mazur NI, Terstappen J, Baral R, Bardají A, et al · · 2023 · cited 294× · PMID 35952703 · DOI 10.1016/s1473-3099(22)00291-2
  2. The Future of Respiratory Syncytial Virus Disease Prevention and Treatment.
    Domachowske JB, Anderson EJ, Goldstein M. · · 2021 · cited 90× · PMID 33656652 · DOI 10.1007/s40121-020-00383-6
  3. Respiratory Syncytial Virus Vaccines: A Review of the Candidates and the Approved Vaccines.
    Topalidou X, Kalergis AM, Papazisis G. · · 2023 · cited 84× · PMID 37887775 · DOI 10.3390/pathogens12101259
  4. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine.
    Walsh EE, Falsey AR, Scott DA, Gurtman A, et al · · 2022 · cited 80× · PMID 34932102 · DOI 10.1093/infdis/jiab612
  5. Prevention and Treatment Strategies for Respiratory Syncytial Virus (RSV).
    Gatt D, Martin I, AlFouzan R, Moraes TJ. · · 2023 · cited 70× · PMID 36839426 · DOI 10.3390/pathogens12020154
  6. Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines.
    Biagi C, Dondi A, Scarpini S, Rocca A, et al · · 2020 · cited 45× · PMID 33187337 · DOI 10.3390/vaccines8040672
  7. The impact of human vaccines on bacterial antimicrobial resistance. A review.
    Jansen KU, Gruber WC, Simon R, Wassil J, et al · · 2021 · cited 39× · PMID 34602924 · DOI 10.1007/s10311-021-01274-z
  8. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When Coadministered With a Tetanus, Diphtheria, and Acellular Pertussis Vaccine.
    Peterson JT, Zareba AM, Fitz-Patrick D, Essink BJ, et al · · 2022 · cited 33× · PMID 34637519 · DOI 10.1093/infdis/jiab505

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