Abstract
Background:WHO recommends vitaminAsupplementation(VAS) at vaccinationcontacts after sixmonths
of age. The effect of this recommendation on mortality has not been evaluated.
Methods: We tested the effect of VAS at vaccination contacts on mortality in a randomised trial in GuineaBissau.
In a subgroup within this trial we studied adverse reactions to VAS and whether VAS modified
known adverse reactions to live and inactivated vaccines and general morbidity during the first month
after supplementation overall and by sex. Children aged 6–17 months were randomised to VAS or placebo
at the day of vaccination (day 0). We interviewed the caretaker, assessed the fontanel and measured
temperature and local reaction at the injection site at home visits on day 1, 2, 3, 7, 14, 21, and 31.
We defined systemic adverse reactions to inactivated and live vaccines as fever on day 1 and 2 and on
4–14 respectively. Clinical symptoms associated with increased intracranial pressure (ICP) on day 1 were
considered possible adverse reactions to VAS.
Results: In 1673 children VAS had no overall effect on clinical symptoms associated with increased ICP
(Relative Risk(RR) = 1.07 (95%CI: 0.85–1.35)). However, VAS was associated with such clinical symptoms
in boys RR = 1.38 (1.00–1.91)) but not in girls (p = 0.03 for interaction between VAS and sex). VAS had no
effect on fever after inactivated vaccines. VAS had no overall effect on fever after live vaccines (RR = 0.86
(0.53–1.39)), but tended to reduce the prevalence of fever in boys (RR = 0.58 (0.30–1.14)), but not in girls
(RR = 1.37 (0.66–2.84)) (p = 0.09 for interaction between VAS and sex). VAS was associated with increased
local reactions to measles vaccine in both sexes (RR = 3.65 (1.20–11.12)).
Conclusion: Adverse reactions were rare, mild and transient and may notin their own right cause concern.
However, VAS caused sex-differential adverse reactions and may have sex-differential effects on adverse
reactions to vaccines.
of age. The effect of this recommendation on mortality has not been evaluated.
Methods: We tested the effect of VAS at vaccination contacts on mortality in a randomised trial in GuineaBissau.
In a subgroup within this trial we studied adverse reactions to VAS and whether VAS modified
known adverse reactions to live and inactivated vaccines and general morbidity during the first month
after supplementation overall and by sex. Children aged 6–17 months were randomised to VAS or placebo
at the day of vaccination (day 0). We interviewed the caretaker, assessed the fontanel and measured
temperature and local reaction at the injection site at home visits on day 1, 2, 3, 7, 14, 21, and 31.
We defined systemic adverse reactions to inactivated and live vaccines as fever on day 1 and 2 and on
4–14 respectively. Clinical symptoms associated with increased intracranial pressure (ICP) on day 1 were
considered possible adverse reactions to VAS.
Results: In 1673 children VAS had no overall effect on clinical symptoms associated with increased ICP
(Relative Risk(RR) = 1.07 (95%CI: 0.85–1.35)). However, VAS was associated with such clinical symptoms
in boys RR = 1.38 (1.00–1.91)) but not in girls (p = 0.03 for interaction between VAS and sex). VAS had no
effect on fever after inactivated vaccines. VAS had no overall effect on fever after live vaccines (RR = 0.86
(0.53–1.39)), but tended to reduce the prevalence of fever in boys (RR = 0.58 (0.30–1.14)), but not in girls
(RR = 1.37 (0.66–2.84)) (p = 0.09 for interaction between VAS and sex). VAS was associated with increased
local reactions to measles vaccine in both sexes (RR = 3.65 (1.20–11.12)).
Conclusion: Adverse reactions were rare, mild and transient and may notin their own right cause concern.
However, VAS caused sex-differential adverse reactions and may have sex-differential effects on adverse
reactions to vaccines.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | The Vaccine Quarterly |
| Vol/bind | 31 |
| Udgave nummer | 31 |
| Sider (fra-til) | 3191-3198 |
| ISSN | 1935-5653 |
| DOI | |
| Status | Udgivet - 2013 |