A Phase III Study to check the Safety and efficacy of the PCV 13 Vaccine in Healthy Infants in India in prevention of Pneumococcal disease caused by Streptococcus pneumonia.
- Registration Number
- CTRI/2022/11/047443
- Lead Sponsor
- G C Chemie Pharmie Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Prospective subjects will only be eligible for randomization if all of the following inclusion criteria, and none of the exclusion criteria, are met at the time of screening:
Inclusion Criteria for Primary Immunization Phase:
1. Healthy PCV-naïve subjects between 6-8 weeks of age (both inclusive) on the day of enrolment, whose 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 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).
Inclusion Criteria for Booster Immunization Phase:
1. Subjects with good health as determined by:
a)Medical history.
b)Physical examination.
c)Clinical judgment of the investigator.
2. Subjects who have completed primary immunization series of the investigational vaccine in the present study.
Exclusion Criteria for the first dose:
1. The 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 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. Subjects who have received any Pneumococcal vaccine prior to
enrolment.
7. Bleeding disorder, contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding screening.
8. History of infections with Human Immunodeficiency Virus (HIV), hepatitis B virus, or hepatitis C virus in the infant or mother.
9. Presence of evolving or changing neurological disorder.
10. Subjects with history of seizures.
11. Axillary temperature = 40.0°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. 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.
15. Subjects who have received any blood products, cytotoxic agents or radiotherapy.
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
1. Generalized allergic reaction in past 3 days .
2. Seizures.
3. Encephalopathy.
4. Axillary temperature of > 40.0°C in past 3 days. .
5. Inconsolable persisting crying (defined as > 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.
Exclusion Criteria for Booster immunization Phase:
1. Subjects 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. Subjects who have already received pneumococcal vaccine booster dose (other than investigational vaccine) from other resources (from different doctor/hospital).
5. Bleeding disorder, contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding booster dose.
6. History of infections with Human Immunodeficiency Virus (HIV),hepatitis B virus, or hepatitis C virus in the infant after primary immunization.
7. Presence of evolving or changing neurological disorder after primary immu
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity <br/ ><br>IgG responses 4 weeks after the 3rd dose of PCV13-TT or PREVENAR 13® <br/ ><br>• Percentage of subjects achieving serotype-specific pneumococcal <br/ ><br>immunoglobulin G (IgG) concentrations = 0.35 µg/mL <br/ ><br>Timepoint: Immunogenicity <br/ ><br>IgG responses 4 weeks after the 3rd dose of PCV13-TT or PREVENAR 13® <br/ ><br>• Percentage of subjects achieving serotype-specific pneumococcal <br/ ><br>immunoglobulin G (IgG) concentrations = 0.35 µg/mL <br/ ><br>
- Secondary Outcome Measures
Name Time Method Immunogenicity and Immune persistence <br/ ><br>IgG responses 4 weeks after booster dose of PCV13-TT or PREVENAR 13® <br/ ><br>• Percentage of subjects achieving serotype-specific pneumococcal immunoglobulin G (IgG) concentrations = 0.35 µg/mL <br/ ><br>• Serotype-specific IgG GMCs. <br/ ><br>• Antibodies measured 28 days after primary series and before booster dose (approximately 12 months post primary series) to determine antibody persistence after primary immunization. <br/ ><br> <br/ ><br>OPA responses in 25% subjects (randomly selected) after the three-dose primary series & booster dose of PCV13-TT or PREVENAR 13® <br/ ><br>• Percentage of subjects with serotype-specific serum OPA titers = 1:8 (LLOQ) <br/ ><br>• Serotype-specific serum OPA GMTs along with their ratios. <br/ ><br> <br/ ><br>Timepoint: IgG responses 4 weeks after booster dose of PCV13-TT or PREVENAR 13®