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

ISRCTN	ISRCTN46335400
DOI	https://doi.org/10.1186/ISRCTN46335400
Protocol serial number	RPC219; PsA-TT-003a
Sponsors	Serum Institute of India Limited (SIIL), Program for Appropriate Technology in Health (PATH), Serum Institute of India (India)
Funder	Bill and Melinda Gates Foundation

Submission date: 14/08/2007
Registration date: 14/08/2007
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

Initiative for Vaccine Research
World Health Organization (WHO)
Department of Immunisation, Vaccines and Biologicals (IVB)
20 Avenue Appia
Geneva
CH-1211
Switzerland

Phone	+41 (0)22 791 3744
Email	preziosim@who.int

Dr Anand Pandit
Scientific

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

Study information

Primary study design	Interventional
Study design	Phase II/III observer-blind randomised active-controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	King Edward Memorial Hospital Ethics Committee, Pune, India, 01/08/2007
Health condition(s) or problem(s) studied	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	Phase II/III
Drug / device / biological / vaccine name(s)	PsA-TT, PsACWY
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	20/11/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	10 Years
Sex	All
Target sample size at registration	340
Key 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
Key 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
Date of first enrolment	20/08/2007
Date of final enrolment	20/11/2007

Locations

Countries of recruitment

India
Switzerland

Study participating centre

Initiative for Vaccine Research

Geneva
CH-1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
Results article	results	15/11/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/03/2019: Internal review.
31/08/2016: Publication references added.