Condition category
Infections and Infestations
Date applied
14/08/2007
Date assigned
14/08/2007
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

http://www.meningvax.org

Contact information

Type

Scientific

Primary contact

Dr Marie-Pierre Preziosi

ORCID ID

Contact details

Initiative for Vaccine Research
World Health Organization (WHO)
Department of Immunisation
Vaccines and Biologicals (IVB)
20 Avenue Appia
Geneva
CH-1211
Switzerland
+41 (0)22 791 3744
preziosim@who.int

Type

Scientific

Additional contact

Dr Anand Pandit

ORCID ID

Contact details

Department of Pediatrics
King Edward Memorial Hospital Research Centre
Sardar Moodliar Road
Rasta Peth
Pune
411011
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC219; PsA-TT-003a

Study information

Scientific title

A phase II/III, observer-blind, randomised, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy children 2 to 10 years of age

Acronym

Study hypothesis

Bacterial meningitis is a life-threatening medical emergency. Morbidity includes hearing loss, chronic seizures, and learning disability. The principal pathogens of bacterial meningitis are Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae type B. Neisseria meningitidis is particularly feared because it has the capability of causing large outbreaks of disease. Endemic meningococcal disease occurs worldwide and is mostly caused by meningococci of serogroups A, B, C, W135 and Y.

Hypothesis:
To compare the immunogenicity of a single dose of the PsA-TT vaccine with that of the Meningococcal A component of the PsACWY vaccine at 28 days after vaccination.

Ethics approval

King Edward Memorial Hospital Ethics Committee, Pune, India, 01/08/2007

Study design

Phase II/III observer-blind randomised active-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Condition

Bacterial meningitis

Intervention

1. One 0.5 ml dose out of a decadose vial of PsA-TT vaccine will be injected intramuscularly (IM) in the right deltoid
2. One 0.5 ml dose of PsACWY vaccine will be injected IM in the right deltoid

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

The percentage of subjects who show a seroconversion for anti-Meningococcal Polysaccharide A (MenPsA) antibodies, i.e., a four-fold increase in post-immunisation serum titre with respect to pre-immunisation serum titre, at 28 days after a single vaccine dose, as measured by a rabbit complement Serum Bactericidal Assay (rSBA).

Secondary outcome measures

Safety:
1. The percentage of subjects with local and systemic post-immunisation reactions during the first four days, adverse events and Serious Adverse Events (SAEs), as measured at 4 and 28 days after vaccination (reactogenicity and short-term safety)
2. The percentage of subjects with SAEs during the entire study duration, as measured at 182 days (6 months) and 364 days (1 year) (long-term safety)

Immunogenicity:
1. The percentage of subjects with anti-MenPsA titre greater than or equal to 1:8 (defined as seroprotection to MenA) at 28 days after a single vaccine dose, as measured by rSBA assay. The percentage of subjects with anti-MenPsA titer greater than or equal to 1:128 (defined as long-term seroprotection to MenA) will be also considered
2. Geometric Mean Titres (GMTs) for anti-MenPsA antibodies at 28 days after a single vaccine dose, as measured by rSBA assay
3. Evaluation of reverse cumulative distribution curves for MenPsA antibody titres at 28 days after a single vaccine dose, as measured by rSBA assay
4. The percentage of subjects who show a seroconversion for anti-MenPsA total Immunoglobulin G (IgG), i.e. a two-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration, at 28 days after a single vaccine dose, as measured by Enzyme-Linked Immunosorbent Assay (ELISA). The percentage of subjects with a four-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration will be also considered

Overall trial start date

20/08/2007

Overall trial end date

20/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 2 to 10 years of age (both included)
2. Written informed consent obtained from parents or legal guardian of the child
3. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
4. Parents or legal guardian capable and willing to bring their child or to receive home visits (for their child) for all follow-up visits
5. Residence in the study area
6. Fully vaccinated according to the local Expanded Program on Immunisation (EPI) schedule

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

340

Participant exclusion criteria

1. Previous vaccination against Neisseria meningitidis
2. Known exposure to Neisseria meningitidis during the three previous months
3. History of allergic disease or known hypersensitivity to any component of the two study vaccines and/or following administration of vaccines included in the local program of immunisation
4. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first 28 days after the study vaccination
5. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines
6. Administration of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines or planned administration during the study period
7. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to the administration of study vaccines (including systemic or inhaled corticosteroids, this means prednisone, or equivalent, greater than 0.5 mg/kg/day; topical steroids are allowed)
8. A family history of congenital or hereditary immunodeficiency
9. History of meningitis or seizures or any neurological disorder
10. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment)
11. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion
12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives
13. Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study
14. Non residence in the study area or intent to move out within one year

Recruitment start date

20/08/2007

Recruitment end date

20/11/2007

Locations

Countries of recruitment

India

Trial participating centre

Initiative for Vaccine Research
Geneva
CH-1211
Switzerland

Sponsor information

Organisation

Serum Institute of India Limited (SIIL)

Sponsor details

212/2
Hadapsar
Pune
411 028
India

Sponsor type

Industry

Website

http://www.seruminstitute.com/

Organisation

Program for Appropriate Technology in Health (PATH)

Sponsor details

1455 NW Leary Way
Seattle
WA 98107
United States of America

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation

Alternative name(s)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

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/26553684
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26553670

Publication citations

Additional files

Editorial Notes

31/08/2016: Publication references added.