Table 1.
Characteristics of the included studies
| Author, year | Study design and settings | Study participants | Vaccine (sponsor) | Placebo | Dose | Gestational weeks at injection (mean±SD of vaccine injection) | No. of study participants | Effect measures | |
|---|---|---|---|---|---|---|---|---|---|
| mother | infants | ||||||||
| Munoz et al. [16] (2003) | Placebo-controlled RCT (double-blinded); USA | Uncomplicated singleton pregnant women (third trimester) | Al(OH)3-adjuvanted purified F protein (Wyeth Lederle) | Sterile isotonic saline | Single dose (50 μg) | 30–34 weeks of gestation (mean±SD is unavailable) | 35 (20 vaccinated vs. 15 controls) | 35 (20 trials vs. 15 controls) | Safety |
| Munoz et al. [17] (2019) | Placebo-controlled RCT (observer-blinded); USA | Uncomplicated singleton pregnant women (third trimester) | Purified F protein nanoparticle (NovaVax) | Sterile isotonic saline | Single dose (120 μg) | 33–35 weeks of gestation (mean±SD is unavailable) | 50 (28 vaccinated vs. 22 controls) | 50 (28 trials vs. 22 controls) | Safety, immunogenicity, and efficacy |
| Madhi et al. [18] (2020) | Placebo-controlled RCT (observer-blinded); multicountry | Uncomplicated singleton pregnant women (third trimester) | Al(OH)3-adjuvanted purified F protein nanoparticle (NovaVax) | Buffer without aluminum | Single dose (120 μg) | 28–36 weeks of gestation (32±2.6) | 3,045 vaccinated versus 1,581 controls | 3,008 trials versus 1,561 controls | Safety, immunogenicity, and efficacy |
| Simoes et al. [19] (2022) | Placebo-controlled RCT (observer-blinded); USA, Chile, Argentina, South Africa | Uncomplicated singleton pregnant women (third trimester) | Al(OH)3-adjuvanted OR unadjuvanted bivalent purified pre-F protein (Pfizer) | Not mentioned | Single dose (120 μg or 240 μg) | 24–36 weeks of gestation (31.1±3.1) | 327 vaccinated versus 79 controls | 325 trials versus 78 controls | Safety, immunogenicity, and efficacy |
| Bebia et al. [20] (2023) | Placebo-controlled RCT (observer-blinded); multicountry | Uncomplicated singleton pregnant women (third trimester) | Unadjuvanted purified pre-F protein (GlaxoSmithKleine) | Saline solution | Single dose (60 μg or 120 μg) | 28–33 weeks of gestation (mean±SD is unavailable) | 145 vaccinated versus 68 controls | 140 trials versus 66 controls | Safety, immunogenicity, and efficacy |
| Kampmann et al. [21] (2023) | Placebo-controlled RCT (observer-blinded); multicountry | Uncomplicated singleton pregnant women (third trimester) | Unadjuvanted bivalent purified pre-F protein (Pfizer) | Not mentioned | Single dose (120 μg) | 24–36 weeks of gestation (30.8±3.5) | 3,695 vaccinated versus 3,697 controls | 3,570 trials versus 3,558 controls | Safety and efficacy |
RCT, randomized control trials.