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Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth

Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00710983
Enrollment
Unknown
Registered
2008-07-08
Start date
2008-07-31
Completion date
2015-01-31
Last updated
2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn, Healthy

Keywords

Mortality, Morbidity, Growth, Immunology

Brief summary

Our group has discovered that routine vaccinations in childhood may have non-specific and sex-differential effects on overall mortality. The effects are so large that they may have marked effects on overall mortality and seriously distort female-to-male mortality rates in high-mortality settings. We recently experienced periods during which oral polio vaccine (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were following all infants as a part of a vitamin A supplementation trial. Surprisingly, we discovered that not receiving OPV was associated with significantly lower mortality in boys, but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly dampened the immunological response to BCG given at birth in both sexes. Based on these observations, receiving OPV at birth may have two negative effects, first, it may increase male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth is given for logistic reasons, to boost polio immunity. There have been no polio cases in Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and growth and 2) immunological response to BCG.

Interventions

Sponsors

Bandim Health Project
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No

Inclusion criteria

Normal birth weight, no overt illness or gross malformations -

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Mortality by sex

Secondary

MeasureTime frame
Morbidity, growth, immunology

Countries

Guinea-Bissau

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026