Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07455305
Brief Summary:
This study was designed as a randomized controlled trial comparing simultaneous and sequential administration of intramuscular vaccines in infants.
Detailed Description:
The study was carried out in the pediatric outpatient vaccination clinic of a private hospital in Istanbul, Türkiye, between 1 September and 15 November 2021.
Infants were eligible if they were younger than 12 months, required two routine intramuscular vaccines during the same visit, and were accompanied by a parent or legal guardian able to provide informed consent.
Infants were excluded if they had received analgesics within six hours prior to vaccination, received vaccines other than hepatitis B, pentavalent combination vaccine (DTaP-IPV/Hib), or pneumococcal conjugate vaccine, or had known neurological, developmental, or motor impairments.
Infants were randomly assigned in a 1:1 ratio to either the simultaneous injection group or the sequential injection group using computer-generated randomization (www.randomizer.org). Allocation was completed prior to the vaccination procedure.
A total of 150 infants were assessed for eligibility; 40 did not meet inclusion criteria. The final sample included 110 infants (55 per group). No participants were lost to follow-up.
Study:
NCT07455305
Study Brief:
Protocol Section:
NCT07455305