None listed
Conditions
Interventions
Intervention1: NUCOVAC -11 [Pneumococcal Polysaccharide conjugate vaccine (Adsorbed), 11 valent.]: Vaccination will be done on Day 0 , Day 28, Day 56 i.e. at 6 8 weeks, 10 12 weeks, and 14 16 weeks of
Sponsors
PANACEA BIOTEC LIMITED
Clinical Research Network India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Infants between 6 to 8 weeks of age Both Inclusive on the day of enrollment whose parents or LAR willing to participate and give written informed consent prior to the study entry 2. Infants with good health as determined by Medical history Physical examination Clinical judgment of the investigator 3. Infants judged to be able to attend all scheduled study visits and to comply with trial procedures 4. Weight of the Infant at enrolment visit greater than or equal to 3.2 kg 5. Infants with an up to date minimal vaccination status at the time of enrollment as per UIP schedule as per local or regional protocols Inclusion Criteria for Booster Immunization Phase 1. Infants with good health as determined by Medical history Physical examination Clinical judgment of the investigator 2. Infants who have completed primary immunization series of the study vaccine in the present study
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Primary Immunization Phase: 1. The parents or LAR are unwilling or unable to give written informed consent to participate in the study 2. Infants who have participated in another trial of an investigational agent within 30 days prior to enrolment 3. Planned participation in another clinical trial during the present trial period 4. Infants whose families are planning to leave the area of the study site before the end of the study period 5. History of culture-proven invasive disease caused by S pneumoniae 6. Infants who have received any Pneumococcal vaccine prior to enrollment 7. Bleeding disorder, contraindicating IM vaccination or receipt of anticoagulants in the 3 weeks preceding inclusion 8. History of Human Immunodeficiency Virus HIV, hepatitis B or hepatitis C in infant or mother 9. Presence of evolving or changing neurological disorder 10. Infants with history of seizures 11. Axillary temperature greater than or equal to 38 degree C in past 3 days 12. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days 13. Planned or elective surgery during the course of the study 14. Infants with a known or suspected impairment of the immune function or those receiving immunosuppressive therapy or having received immunosuppressive therapy within 1 month prior to study entry including systemic corticosteroids or those who have received a parenteral immunoglobulin preparation 15. Infants who have received any blood products, cytotoxic agents or radiotherapy 16. Infants with history of anaphylaxis or any serious vaccine reaction or allergy to any vaccine component 17. Infants 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 Exclusion criteria for the second or third dose 1. Generalized allergic reaction within 48 hours of administration of previous vaccine dose 2. Seizures 3. Encephalopathy 4. Axillary temperature of greater than 40 degree Celsius within 48 hours of previous vaccine dose 5. Inconsolable persisting crying defined as greater than 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 Exclusion Criteria for Booster immunization Phase 1. Infants who have participated in another trial after primary immunization 2. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days 3. History of culture-proven invasive disease caused by S pneumonia after primary immunization 4. Infants who have already received pneumococcal vaccine booster dose other than Investigational vaccine from other resources from different doctor or hospital 5. Bleeding disorder contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding booster dose 6. History of Human Immunodeficiency Virus HIV hepatitis B or hepatitis C in infant after primary immunization 7. Presence of evolving or changing neurological disorder after primary immunization 8. Axi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the immune response in terms of serotype-specific IgG concentrations induced by 11 common serotypes of NUCOVAC -11 vaccine alone and in comparison, to 13-valent PREVENAR 13 , 1 month after three dose series. Timepoint: Day 0 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the immune response in terms of serotype-specific IgG concentrations induced by 11 common serotypes of NUCOVAC -11 vaccine alone and in comparison, to 13-valent PREVENAR 13 , 4 weeks after booster dose. 2. To evaluate serum functional antibody response in terms of serotype specific OPA titers in random subset of 25% vaccinated subjects of NUCOVAC -11 compared to an equal number of subjects vaccinated with PREVENAR 13 vaccine at 4 weeks after a three-dose primary series & four weeks after the booster dose. 3. To assess and compare the safety and reactogenicity of NUCOVAC -11 vaccine with PREVENAR 13 throughout the study.Timepoint: Day 0, Day 84 for primary series; and Pre-booster and 4 weeks after the booster dose. | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Panacea Biotec Limited
Outcome results
None listed