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)
| ISRCTN | ISRCTN17662153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17662153 |
| Protocol serial number | PsA-TT-001 |
| Sponsor | Serum Institute of India Limited (SIIL) (Secondary Sponsor - Program for Appropriate Technology in Health [PATH], USA) |
| Funder | Program for Appropriate Technology in Health (PATH) (USA) - grant from the Bill and Melinda Gates Foundation |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 01/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marie-Pierre Preziosi
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 3744 |
|---|---|
| preziosim@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase I double-blind randomised trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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) |
| Study objectives | Exploratory study whose primary objective is to test reactogenicity and safety. The comparison between groups will be descriptive. |
| Ethics approval(s) | Ethics approval received 23/06/2005 |
| Health condition(s) or problem(s) studied | Meningococcal disease |
| Intervention | 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 Toxoid) 2. Reference vaccine group: Sanofi Pasteur Meningococcal Polysaccharide Vaccine A+C 3. Control vaccine group: Serum Institute of India Limited (SIIL) Tetanus Toxoid (Adsorbed) IP |
| Intervention type | Biological/Vaccine |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Incidence of adverse events including solicited adverse events and laboratory abnormalities over 4 weeks post-vaccination |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/07/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 72 |
| Key inclusion criteria | Healthy adults between 18 and 35 years of age |
| Key exclusion criteria | Any condition that may affect the health of the subject or the interpretation of the results; pregnancy or lactation |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/07/2006 |
Locations
Countries of recruitment
- India
- Switzerland
Study participating centre
World Health Organization
Geneva
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/11/2015 | Yes | No | |
| Results article | results | 15/11/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/03/2019: Internal review.
31/08/2016: Publication references added.
