A clinical study to assess the safety, tolerability, reactogenicity & immunogenicity of pneumococcal polysaccharide conjugate vaccine in 18 to 45 years old healthy adults.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2022/03/041495
- Lead Sponsor
- Biological ELimited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Healthy male and non-pregnant female subjects between 18-45 years of age at the time of vaccination;
2. Subjects who provide voluntary written informed consent to participate in the study and are capable of comprehending and complying with study requirements and procedures, able and willing to complete subject diary and to return for all scheduled follow-up visits, and have expressed availability for the required study period, with access to a consistent means of telephone contact, either residential land line or mobile.
3. Free of obvious health problems [with no significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, mental or haematological functional abnormalities or illness that require medical therapy] as established by medical history and clinical assessment;
4. Adult male subjects willing to follow acceptable methods of contraception (e.g. condom, with or without spermicide) or practice abstinence and agreeing not to make their female partners pregnant from the time of vaccination until the end of the study. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration.
5. Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the dose of vaccination in the study
6. No clinically significant abnormal laboratory parameters at baseline as judged by the investigator.
7. Subjects willing to avoid consumption (ingestion) of chronic herbal medication during the course of the study.
1. Previous history of pneumococcal vaccination;
2. History of Invasive Pulmonary Disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or any culture-confirmed invasive disease caused by S. pneumoniae;
3. History of allergic or anaphylactic reaction to any vaccine or vaccine-related component or known hypersensitivity to any component of the study vaccine.
4. Any acute or serious infection needing systemic antibiotics or antiviral treatment in last 7 days;
5. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, or haematological functional abnormality or major congenital defects or illness that requires medical therapy, as determined by medical history or clinical assessment.
6. Epilepsy, a history of seizures or convulsions, or a family history of mental illness;
7. History of any coagulation or other blood disorder (e.g. thalassemia, thrombocytopenia, disorders of the lymphocytes, anaemias, etc.) or receipt of anti-coagulants in the past 3 weeks;
8. Subjects who have received any blood products, cytotoxic agents or radiotherapy within the last 3 months;
9. Any licensed or investigational drug or vaccine administered within the 90 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine;
10. Known or suspected immunosuppression or immunodeficiency;
11. Any laboratory abnormality that could increase the risk associated with study participation or interfere with the interpretation of study results;
12. Inability or unwillingness to abide by the requirements of the study;
13. Any participant who cannot be adequately followed for safety, tolerability, reactogenicity and immunogenicity according to the study plan;
14. Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study;
15. Suspicion or recent history (within the past year) of alcohol or drug abuse.
16. An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel.
17. Any medical or social condition that in the opinion/judgement of the investigator will interfere with the study objectives or pose a risk to the study subject or may prevent the subject from completing the study follow up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of subjects with solicited local and systemic adverse reactions <br/ ><br>2.Proportion of subjects with unsolicited local and systemic adverse events <br/ ><br>3.Any clinically significant abnormal haematology and biochemistry laboratory parameters. <br/ ><br>4.Serious adverse events (SAEs) and medically attended adverse events (MAAE) if anyTimepoint: 1. during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days <br/ ><br>2.during the total post vaccination follow up period till day 28. <br/ ><br>3.until day 28 post single dose vaccination. <br/ ><br>4. During the study period
- Secondary Outcome Measures
Name Time Method Geometric Mean Fold Rise (GMFR) in serotype specific anti-PnCPS IgG titresTimepoint: At Day 28 post vaccination.;Geometric mean titre (GMT) of serotype specific anti-PnCPS IgG antibodiesTimepoint: at day 28 post vaccination.;Proportion of subjects achieving =2-fold and =4-fold increase in serotype specific anti-PnCPS IgG antibody titreTimepoint: At day 28;Proportion of subjects achieving seroconversionTimepoint: At day 28 post vaccination