None listed
Conditions
Interventions
Intervention1: PCV-13 (TT/DT)- 13-valent Pneumococcal Polysaccharide
Conjugate Vaccine (TT/DT) (1,3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) developed by Beijing Minhai Biotechnology Co., Ltd
Diphtheria CRM197 Protein)] of Pfizer Inc.: For Cohort 1 & 2: All subjects will receive a single dose (0.5 mL) of comparator vaccine
intramuscularly into the deltoid muscle of the nondominant arm.
Fo
Sponsors
Novo Medi Sciences Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: For Cohort 1 & 2 1. Healthy subjects aged 6 – 65 years (both inclusive) on the day of enrolment & subjects/ parents/ LARs are willing to participate and give written informed consent prior to the study entry. 2. Children & adolescents who have history of primary immunization with Pneumococcal vaccine or Adult who are pneumococcal vaccine naïve. 3. Subjects with good health as determined by: a) Medical history. b) Physical examination. c) Clinical judgment of the investigator 4. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. 5. Negative urine pregnancy test for all female subjects who are of childbearing potential. For Cohort 3 1. Healthy subjects aged 6 - 8 weeks (both inclusive) on the day of enrolment & parents/LARs are willing to participate and give written informed consent prior to the study entry. 2. Subjects with good health as determined by: a) Medical history b) Physical examination c) Clinical judgment of the investigator 3. Subject’s parents/LARs must be able to comprehend and comply with study requirements and procedures, and willing to complete subject diary and to return with the subject for all scheduled follow up visits. 4. Subjects must have been born full-term, at randomization. 5. Weight of the infant at enrolment visit = 3.2 kg. 6. Subjects who have not received any Pneumococcal vaccine prior to enrolment. 7. Subjects with an up-to-date minimal vaccination status (includes, BCG vaccine, first dose of OPV, IPV and first dose of vaccine against Hep B, DPT and Hib that could be administered as pentavalent vaccine) at the time of enrolment as per UIP schedule (per local/regional protocols)
Exclusion criteria
Exclusion criteria: Exclusion Criteria for the first dose (for all cohorts): 1. The subjects/parents or LARs are unwilling or unable to give written informed consent to participate in the study. 2. Subjects 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. Subjects who/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. Bleeding disorder, contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding screening. 7. History of infections with HIV, HBV, or HCV in the infant or mother. 8. Presence of evolving or changing neurological disorder. 9. Subjects with history of seizures. 10. Axillary temperature =40.0°C in past 3 days. 11. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days 12. Planned or elective surgery during the course of the study. 13. Subjects 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. 14. Subjects who have received any blood products, cytotoxic agents or radiotherapy. 15. Vaccination with any licensed or investigational pneumococcal vaccine within the last year 16. Subjects with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component. This includes such reactions in older siblings and also includes all components of the UIP vaccines. 17. Subjects 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 / Third Dose (For cohort 3 only) 1. Generalized allergic reaction in past 3 days 2. Seizures 3. Encephalopathy 4. Axillary temperature =40.0°C in past 3 days 5. Inconsolable persisting crying (more than 3 hours in past 3 days) 6. Generalized cyanosis within past 3 days 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 |
|---|---|
| Cohort 1 & 2 Serotype-specific IgG GMCs alone & in comparison to PREVENAR 13® 4 weeks after single dose. GMFRs in serotype-specific IgG alone & in comparison to PREVENAR 13® from before vaccination to 4 weeks after single dose. Percentage of subjects achieving serotype-specific pneumococcal IgG concentrations = 0.35 µg/mL alone & in comparison to PREVENAR 13® from before vaccination to 4 weeks after single dose. Timepoint: Cohort 1 & 2 4 weeks after single dose. Cohort 3: 4 weeks after the 3rd dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity Endpoints For Infants (Cohort 3) OPA responses: alone and in comparison, to Prevenar 13® Percentage of subjects with OPA titer = 1:8 measured 4 weeks post 3rd dose of study vaccine. OPA geometric mean titer (GMT) measured 4 weeks post 3rd dose of study vaccine. Safety Endpoints For Infants (Cohort 3) Incidences of solicited local and systemic events collected at 30 minutes and through Day 0 to Day 7 after each vaccination. Incidences of unsolicited AEs through 28 days post primary series. Incidences of SAEs during the entire study period. For children, adolescents & adults (Cohort 1 & 2) Incidences of solicited local and systemic events collected at 30 minutes and through Day 0 to Day 7 after vaccination. Incidences of unsolicited AEs through 28 days post vaccination. Incidences of SAEs during the entire study period. Timepoint: 4 weeks post 3rd dose of study vaccine Safety throughout the study | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Clinical Research Network India
Outcome results
None listed