None listed
Conditions
Interventions
Intervention1: NucoVac®-11
Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 11 Valent (1, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) of Panacea Biotec Ltd.: 2 doses of test vaccine will be administered with a gap of
Sponsors
Panacea Biotec Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy PCV-naïve toddler between 12-23 months of age (Both Inclusive) on the day of enrollment. PCV-naïve toddlers are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine. 2. Toddlers whose parents/LAR willing to audio visual consent process and give written informed consent prior to the study entry. 3. Toddlers with an up-to-date minimal vaccination status for their age at the time of enrollment (â??minimalâ??defined as single dose of BCG, 3 doses of Polio vaccine, DPT, Hepatitis B and single dose of Measles at the time of enrollment). 4. Toddlers with good health as determined by: 4.1 Medical history 4.2 Physical examination 4.3 Clinical judgment of the investigator 5. Toddlers judged to be able to attend all scheduled study visits and to comply with trial procedures.
Exclusion criteria
Exclusion criteria: 1. History of culture-proven invasive disease caused by S. pneumoniae. 2. Toddler who have received any pneumococcal vaccine prior to enrollment. 3. History of Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C in toddler. 4. Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drug within the 6 months prior to administration of the study vaccine. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day or equivalent. 5. Administration of immunoglobulins and/or any blood products during the period starting three months before the administration of study vaccine or planned administration during the study period. 6. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). 7. History of any neurological disorder, meningitis or seizures. 8. Axillary temperature >= 38.0°C in past 3 days. 9. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 30 days before the administration of study vaccine or planned use during the study period. 10. Planned or elective surgery during the course of the study. 11. Toddler with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component. 12. Toddler with any serious chronic disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives or compromise the safety of the subject. 13. The parents or LAR are unwilling or unable to give written informed consent to participate in the study 14. Toddlers whose families are planning to leave the area of the study site before the end of the study period. 15. Todllers who have participated in another trial or received an investigational agent within 30 days of enrolment. Exclusion criteria for the second dose 1. Hypersensitivity to vaccine within 48 hours of administration of previous vaccine dose 2. Seizures 3. Encephalopathy 4. Axillary temperature of > 40oC within 48 hours of previous vaccine dose 5. Inconsolable persisting crying (defined as > 3 hours within 48 hours of previous vaccination), 6. Generalized cyanosis within 48 hours of previous vaccine dose 7. Any serious reaction after previous dose which can compromise the safety of the subject if continued in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence, intensity and relationship to vaccination of solicited(local and systemic ) adverse reactions during the 30 minutes of post vaccination observation period and for 7 consecutive days (day 0 to 6) after each vaccination 2. Incidence, intensity and relationship to vaccination of unsolicited adverse reactions during the entire study period. 3. Incidence, intensity and relationship to vaccination of Serious Adverse Events (SAEs) during the entire study period. Timepoint: 1. During the 30 minutes of post vaccination observation period and for 7 consecutive days (day 0 to 6) after each vaccination 2. During the entire study period. 3. During the entire study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects with anti-pneumococcal polysaccharide conjugate (PnCPS) IgG antibody concentration 0.35 μg/ml (as measured by ELISA) against each of the vaccine serotypes at day 30 post 2nd dose of test vaccine. 2. Anti-PnCPS IgG ELISA geometric mean titre (GMT) against each of the vaccine serotypes with their two sided 95% Cls at day 30 post 2nd dose of test vaccine. Timepoint: Day 0 before vaccination and on day 90 in follow up visit. Results of the secondary outcome shall be come after 4 months of completion of the trial | — |
Countries
India
Contacts
Public ContactDr Lalitendu Mohanty
Panacea Biotec Ltd
Outcome results
None listed