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Does Timeliness of DTaP-IPV-Hib Vaccination Affect Development of Atopic Dermatitis Before 1 Year of Age?

NCT03142139 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1027559

Last updated 2017-05-09

No results posted yet for this study

Summary

It has been found that the non-live vaccine against Diphtheria, Tetanus, and Pertussis (DTP) in addition to its disease specific effects may have so called "non-specific effects" with the potential to affect sensitivity towards vaccine unrelated pathogens, resulting in excess mortality(Aaby, Kollmann, \& Benn, 2014).

A recent study from Australia found that delayed vaccination with the first dose of Diphtheria, Tetanus, and acellular Pertussis(DTaP)-containing vaccine is associated with reduced risk of atopic dermatitis (aOR: 0.57; 95% CI: 0.34-0.97, P = 0.04) and reduced use of medication against atopic dermatitis (aOR: 0.45; 95% CI: 0.24-0.83, P = 0.01)(Kiraly et al., 2016).

This register based observational study aims to extend the existing knowledge on non-specific effects of non-live vaccines by testing the above finding, that delayed vaccination with Diphtheria, Tetanus, acellular Pertussis - Inactivated Polio vaccine - Haemophilus influenzae type b (DTaP-IPV-Hib) is associated with lower risk of developing atopic dermatitis before 1 year of age in the Danish birth cohorts from 1997-2012.

Conditions

Interventions

BIOLOGICAL

RQ1a: Delayed vs. timely vaccination with the 1st dose of DTaP-IPV-Hib

Children will be categorized as "timely vaccinated" if they receive the 1st dose within the month of scheduled vaccination: * "timely vaccinated": received 1st dose of DTaP-IPV-Hib before 4 months of age * "delayed vaccinated": did not receive the first dose of DTaP-IPV-Hib before 4 months of age.

BIOLOGICAL

RQ1b: Delayed vs. timely vaccination with the 2nd dose of DTaP-IPV-Hib

Children will be categorized as "timely vaccinated" if they receive the 2nd dose within the month of scheduled vaccination: * "timely vaccinated": received 2nd dose of DTaP-IPV-Hib before 6 months of age * "delayed vaccinated": did not receive the 2nd dose of DTaP-IPV-Hib before 6 months of age.

BIOLOGICAL

RQ2: Vaccination with DTaP-IPV-Hib compared to being unvaccinated

• Vaccination status will be assessed as a time dependent exposure, whereby children will be categorized as "unvaccinated" until date of vaccination where they will shift exposure group to "vaccinated".

Sponsors & Collaborators

  • Murdoch Childrens Research Institute

    collaborator OTHER

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Signe Sørup, PhD · CVIVA, Bandim Health Project

Eligibility

Min Age
24 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-01-01
Primary Completion
2014-12-31
Completion
2014-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142139 on ClinicalTrials.gov