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The booster study took place between June and October 2006.
The relatively low proportion of subjects evaluated for booster vaccination is due to only two countries out of three (Argentina and Nicaragua) participating in the booster study.
A total of 158 subjects who completed the three-dose primary vaccination course with PHiD-CV in study NCT00678301 were invited to participate in the present booster study.
Immunogenicity results one month post-primary were derived from the primary vaccination study NCT00678301 by re-calculation based on the ATP immunogenicity cohort of the booster study.
This open-label extension booster study followed a Phase III study of 1206 adults who had received two 3.75 μg doses of primary AS03A-adjuvanted or non-adjuvanted H5N1 split-virus vaccine (A/Vietnam/1194/2004; clade 1) (NCT00449670).
- The objectives of this booster study in Malian children were to assess the safety in terms of adverse events (AEs) with grade 3 intensity (primary objective), AEs of any intensity and the immunogenicity (secondary objectives) of a fourth consecutive (booster) dose of PHiD-CV.
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It is not clear why the delayed third dose is associated with a marked increase in HBs response but not CS response and will need to be investigated further in delayed booster studies.
Various booster vaccination studies with PHiD-CV conducted in Europe, Asia and Latin America have shown that a fourth consecutive (booster) dose was well tolerated and immunogenic in young children.
Additionally, the same laboratory tests - for which quality procedures are in place to ensure stability of the test results were used in the primary and booster vaccination studies.
PCV10 has been shown to be immunogenic in a number of primary and booster vaccination studies [ 71– 75], and also to reduce vaccine-type pneumococcal carriage [ 76].
To investigate the need for this 'preschool' booster we studied anti-HBsAg (anti-HBs) IgG titres in children immunised with the current (0, 1, 2, 12 month) UK infant schedule before and after a booster dose of HBV vaccine in mid-childhood.
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