Vaccine related reactogenicity for primary immunization: a randomized controlled trial of 23(wider) vs. 25(narrower)...

Area of Science:

• Pediatrics
• Immunology
• Vaccination Technology

Background:

• Infant immunization is crucial for disease prevention.
• Vaccine administration involves needles, and needle characteristics can influence patient experience and local reactions.
• Understanding the impact of needle gauge on reactogenicity is important for optimizing vaccination procedures.

Purpose of the Study:

• To compare vaccine-related local and systemic reactogenicity in healthy infants during primary immunization using 23-gauge versus 25-gauge needles.
• To assess differences in reported symptoms such as swelling, tenderness, redness, and fever between the two needle groups.

Main Methods:

• A randomized controlled trial involving 155 healthy infants undergoing primary immunization.
• Participants were assigned to receive immunizations with either 23-gauge or 25-gauge needles.
• Parent-reported local and systemic reactions were recorded daily for three days post-immunization.

Main Results:

• Local reactions like swelling and tenderness were common but statistically similar between the 23-gauge and 25-gauge groups.
• Fever showed a trend towards being higher in the 23-gauge group on day 1, but overall fever and other local reactions were similar between groups over three days.
• Infants receiving immunizations with the 23-gauge needle experienced significantly shorter crying times compared to those receiving the 25-gauge needle.

Conclusions:

• Needle gauge (23 vs. 25) did not significantly alter local reactogenicity during infant primary immunization.
• While fever was marginally reduced with the 25-gauge needle, crying duration was significantly shorter with the 23-gauge needle.
• Larger studies are recommended to objectively evaluate reactogenicity outcomes related to needle gauge in infant vaccinations.