Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
31/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marie-Pierre Preziosi

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3744
preziosim@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PsA-TT-001

Study information

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)

Acronym

Study hypothesis

Exploratory study whose primary objective is to test reactogenicity and safety. The comparison between groups will be descriptive.

Ethics approval

Ethics approval received 23/06/2005

Study design

Phase I double-blind randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Drug names

Primary outcome measures

Incidence of adverse events including solicited adverse events and laboratory abnormalities over 4 weeks post-vaccination

Secondary outcome measures

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

Overall trial start date

01/08/2005

Overall trial end date

31/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adults between 18 and 35 years of age

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

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

Recruitment start date

01/08/2005

Recruitment end date

31/07/2006

Locations

Countries of recruitment

India

Trial participating centre

World Health Organization
Geneva
CH-1211
Switzerland

Sponsor information

Organisation

Serum Institute of India Limited (SIIL) (Secondary Sponsor - Program for Appropriate Technology in Health [PATH], USA)

Sponsor details

212/2
Hadapsar
Pune
411028
India
+91 (0)206 993 900 ext. 2384
contact@seruminstitute.com

Sponsor type

Industry

Website

http://www.seruminstitute.com/

Funders

Funder type

Charity

Funder name

Program for Appropriate Technology in Health (PATH) (USA) - grant from the Bill and Melinda Gates Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553690
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553670

Publication citations

Additional files

Editorial Notes

31/08/2016: Publication references added.