Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03142139
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
Murdoch Childrens Research Institute
Information provided by (Responsible Party):
Bandim Health Project

Brief 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.


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

Layout table for study information
Study Type : Observational
Actual Enrollment : 1027559 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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:

  • "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".




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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"




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   24 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The study population is sampled from Danish Medical Birth Register, which contains information on all individuals who are born in Denmark.
Criteria

Inclusion Criteria:

  • Born in Denmark between between 1 January 1997 - 31 December 2012

Exclusion Criteria:

  • Do not receive 1st dose of DTaP-IPV-Hib before 1 year of age
  • Died before 24 months of age
  • Migrate before 24 months of age
  • Receive any vaccines other than DTaP-IPV-Hib, with or without PCV before 12 months of age
  • Develop Atopic Dermatitis prior to baseline
  • Have missing confounder information

Information from the National Library of Medicine

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


Sponsors and Collaborators
Bandim Health Project
Murdoch Childrens Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Signe Sørup, PhD CVIVA, Bandim Health Project

Publications:

Layout table for additonal information
Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT03142139     History of Changes
Other Study ID Numbers: DTaP-Delay
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bandim Health Project:
Observational study; DTaP-IPV-Hib; Atopic Dermatitis; AD; Heterologous immunity; Non-specific effects; Non-targeted effects; Immunization;

Additional relevant MeSH terms:
Layout table for MeSH terms
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs