Effect of needle size on serum antibody responses and incidence of general reactions following routine immunisations in infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62032215

Enrollment

696

Registered

2004-01-23

Start date

2002-01-20

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Vaccination Infections and Infestations Vaccination

Interventions

1. 23 gauge 25 mm - wider gauge long needle 2. 25 gauge 16 mm - narrower gauge short needle 3. 25 gauge 25 mm - narrower gauge long needle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy infants attending routine immunisation clinics at eight general practices.

Exclusion criteria

Exclusion criteria: 1. Infants with severe chronic disease 2. Infants who may receive treatment likely to alter the immune response or infants with any conditions which could preclude evaluation of the response, e.g. congenital or acquired immunodeficiency 3. Infants who have already received Diphtheria-Tetanus-Pertussis (DPT)/Hib vaccines

Design outcomes

Primary

Measure	Time frame
1. Comparison of geometric mean titres of Diphtheria/Tetanus and Hib antibodies between needle size groups 2. Comparison of incidence of general and local reactions between needle size groups at three time points - following vaccination at two, three and four months	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 11, 2026