A phase I, double-blind, randomized study to evaluate the safety and immunogenicity of a new Meningococcal A Conjugate vaccine versus a Meningococcal Polysaccharide A+C reference vaccine and a Tetanus Toxoid control vaccine, given as single intramuscular injections in healthy adults from 18 to 35 years of age (India)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17662153

Enrollment

Registered

2005-07-22

Start date

2005-08-01

Completion date

Unknown

Last updated

2019-03-25

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

Conditions

Meningococcal disease Infections and Infestations Meningococcal disease

Interventions

Single intramuscular injection of one of the following: 1. Study vaccine group: Serum Institute of India Limited (SIIL) PsA-TT (Meningococcal A Polysaccharide conjugated to Tetanus Tox

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy adults between 18 and 35 years of age

Exclusion criteria

Exclusion criteria: Any condition that may affect the health of the subject or the interpretation of the results; pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events including solicited adverse events and laboratory abnormalities over 4 weeks post-vaccination	—

Secondary

Measure	Time frame
1. Descriptive assessment of the immune response 4 weeks post-vaccination in terms of serum bactericidal activity using baby rabbit complement (SBA/BRC) and anti-PsA IgG response 2. Descriptive assessment of the persistence of an immune response 24 and 48 weeks post-vaccination in terms of SBA/BRC and anti-PsA IgG response	—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026