Does Timeliness of DTaP-IPV-Hib Vaccination Affect Development of Atopic Dermatitis Before 1 Year of Age?
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|ClinicalTrials.gov Identifier: NCT03142139|
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 9, 2017
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.
|Condition or disease||Intervention/treatment|
|Atopic Dermatitis||Biological: RQ1a: Delayed vs. timely vaccination with the 1st dose of DTaP-IPV-Hib Biological: RQ1b: Delayed vs. timely vaccination with the 2nd dose of DTaP-IPV-Hib Biological: RQ2: Vaccination with DTaP-IPV-Hib compared to being unvaccinated|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||1027559 participants|
|Official Title:||Timing of Vaccination With the Non-live DTaP-IPV-Hib Vaccine and Development of Atopic Dermatitis Before 1 Year of Age - a Danish Register Based Cohort Study|
|Actual Study Start Date :||January 1, 1997|
|Actual Primary Completion Date :||December 31, 2014|
|Actual Study Completion Date :||December 31, 2014|
Danish Birth Cohorts 1997-2012
RQ1a: Delayed vs. timely vaccination with the 1st dose of DTaP-IPV-Hib
RQ1b: Delayed vs. timely vaccination with the 2nd dose of DTaP-IPV-Hib among children who received a timely first dose of DTaP-IPV-Hib
RQ2: Vaccination with DTaP-IPV-Hib compared to being unvaccinated on development of Atopic Dermatitis.
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:
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:
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".
- Atopic dermatitis (AD) [ Time Frame: RQ1.a+ 1.b: Registered AD from baseline until 12 months of age. RQ2: AD is assessed from baseline (3 months of age) through follow-up (until 8 months of age) ]Atopic dermatitis (AD) is categorized according to an algorithm derived and developed from a recent Danish study on the incidence of atopic diseases in Denmark and Sweden (Henriksen et al., 2015). The algorithm uses register information to identify AD including ICD- diagnostic codes from the Danish National Patient Registry(DNPR)(Lynge, Sandegaard, & Rebolj, 2011) and Anatomical Therapeutic Chemical classification codes(ATC) from the Danish National Prescription Register(Kildemoes, Sorensen, & Hallas, 2011)
- Receipt of medication for atopic dermatitis (only for the primary investigation 1.a) [ Time Frame: Receipt of medication for atopic dermatitis from baseline until end of follow-up is assessed at 12 months of age. ]
This secondary outcome is defined as having a prescription of either ATC code:
D11AH "agents for dermatitis: tacrolimus, pimecrolimus" or D07 "corticosteroids for topical use"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142139
|Principal Investigator:||Signe Sørup, PhD||CVIVA, Bandim Health Project|