Infants’ immunizations, their timing and the risk of allergic diseases (INITIAL) – an observational prospective cohort study

Infants’ immunizations, their timing and the risk of allergic diseases (INITIAL) – an observational prospective cohort study - INITIAL

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029677

Enrollment

4500

Registered

2022-08-03

Start date

2023-09-11

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

J45.0 J30.1 L20 T78

Interventions

Group 1: Participanting families receive 10 questionnaires on allergy symptoms, vaccination advice and influencing factors during five years. Participants in this group decide not to vaccinate their c

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Parents of children four to five weeks of age (U3). - Signed informed consent regarding electronic transmission of medical information for research purposes. - Reading, writing and understanding the German language

Exclusion criteria

Exclusion criteria: - Families already participating in the study with a child. - Missing digital device with Internet access or a contact email address.

Design outcomes

Primary

Measure	Time frame
The following five primary endpoints are equal at five years of age (U9) and are assessed by physician-confirmed parental statements (repeating questionnaires) of lifetime prevalence: (a.) any atopy (asthma, hay fever, atopic dermatitis, food allergy). b.) asthma c.) hay fever d.) eczema = atopic dermatitis e.) food allergy	—

Secondary

Measure	Time frame
Secondary outcome measures are descriptive and exploratory. They include - Other atopy such as contact dermatitis, and other allergens, (e.g. house dust or animal hair). - Other measuring points at one year of age (U6) and three years of age (U7a). - Intensity of advice is analyzed individually and aggregated in the form of an a priori defined sum score weighted by the following aspects: - Self-informed whether book or internet (2), - information provided by the physician during the preventive care (2), - during the vaccination appointment (1) - or as a separate appointment (3) - and no consultation at all (0). - Information transfer desired and received is exploratory.	—

Measure

Time frame

Secondary outcome measures are descriptive and exploratory. They include - Other atopy such as contact dermatitis, and other allergens, (e.g. house dust or animal hair). - Other measuring points at one year of age (U6) and three years of age (U7a). - Intensity of advice is analyzed individually and aggregated in the form of an a priori defined sum score weighted by the following aspects: - Self-informed whether book or internet (2), - information provided by the physician during the preventive care (2), - during the vaccination appointment (1) - or as a separate appointment (3) - and no consultation at all (0). - Information transfer desired and received is exploratory.

—

Countries

Germany

Contacts

Public ContactJennifer Wrenger

Gerhard Kienle-Lehrstuhl, Fakultät für Gesundheit, Private Universität Witten/Herdecke gGmbH

jennifer.wrenger@uni-wh.de0049 2302 - 926 7730

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026