Zaman 2008.
Methods | The study was a prospective, controlled, blinded, randomized trial. | |
Participants | Country: Bangladesh.
Number: 168 women in the intervention group and 172 women in the control group. Mean age: 24.9 years. Mean gestational age: data not available. |
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Interventions | 23‐valent pneumococcal polysaccharide vaccine vs influenza vaccine. | |
Outcomes | Incidence of neonatal influenza. Incidence of maternal influenza. Percentage of mothers with seroprotection. |
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Notes | The main purpose of the trial was to assess the effectiveness of influenza vaccine. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomization sequence was computer‐generated. |
Allocation concealment (selection bias) | Low risk | The randomization sequentially numbered opaque envelopes with data regarding assignments to study groups were provided to each clinic. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “double blind”. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “double blind”. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Of the mother–infant pairs, 316 were observed for the full 24‐week period. |
Selective reporting (reporting bias) | Low risk | All outcomes were predefined and reported. |
Other bias | Low risk | The trial appears to be free of industry sponsorship and the conflict of interest was declared. |
GM: geometric mean vs: versus