None listed
Conditions
Interventions
Intervention1: ACYW135 Meningococcal Plolysacchride Vaccine: ACYW135 Meningococcal Plolysacchride Vaccine,
Dose 0.5 ml,Administer by subcutaneous injection
Control Intervention1: Meno mune: ACYW135 Me
Sponsors
Prosper channel Lifescience India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy Indian subjects of about 2 to 55 years of age the subjects (or their guardians) are able to understand and sign the informed consent/assent (in case of child). 2.Healthy male or female by history, physical examination and clinical judgment of principal investigator and who complies with requirements of vaccination of this product. 3. Axillary temperature 4.Be able to comply with the requirements of the clinical trial protocol: - Have no history of same type of vaccination and vaccination with other products within last 1 week.
Exclusion criteria
Exclusion criteria: 1 Previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine 2 Receipt of blood product including immunoglobulin, or any other blood-derived products in the past 3 months 3 Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) 4 History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically 5 At high risk, in the opinion of the Investigator, for meningococcal disease during the trial 6 Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances 7 At high risk, in the opinion of the Investigator, for meningococcal disease during the trial 8 Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion 9 Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C) 10 Receipt of oral or injectable antibiotic therapy within 72 hours prior to the inclusion of study 11 Receipt of any vaccine in the 4 weeks preceding trial, except for Influenza vaccination, which may be received at least 2 weeks before study vaccines 12 Known thrombocytopenia, contraindicating intramuscular vaccination 13.Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination 14. pregnant or lactating womenn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in antibody titers of Neisseria meningitides sero-groups A/C/Y/W-135 from baseline in Test Group (Meningococcal Polysaccharide Vaccine ACYW135) compared to Reference Group [Menomune®]Timepoint: base line to 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety in comparison to reference Group [Menomune®]Timepoint: baseline to 28 days | — |
Countries
India
Contacts
Public ContactMr Rajeev Pathak
Prosper Channel Life sceince India Pvt Ltd
Outcome results
None listed