Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age and in children 6 to 17 years of age in India
- Conditions
- Preventive Pneumococcal Infections
- Registration Number
- CTRI/2014/05/004608
- Lead Sponsor
- Pfizer Limited
- Brief Summary
This is a phase 4, open-label, single-arm, multicenter study to describe the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age and in children 6 to 17 years of age in India. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
In the adult cohort 50 to 65 years of age, 1400 subjects will receive a single dose of 13vPnC. In a subset of 400 subjects, 2 blood samples will be collected immediately before and approximately 1 month after vaccination for assessment of the immune responses. Safety will be assessed in all subjects throughout the study.
In the pediatric cohort 6 to 17 years of age, 200 subjects will receive a single dose of 13vPnC, 2 blood samples will be collected immediately before and approximately 1 month after vaccination for assessment of the immune response. Safety will be assessed in all subjects throughout the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 1200
- 1.Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject or the subject’s parent/legal guardian has been informed of all pertinentaspects of the study.
- If a subject or the subject’s parent/legal guardian is illiterate, he/she must make his/her mark (eg, thumbprint) on the ICD and it must be signed and dated by an impartial witness who was present throughout the entire informed consent process.
- If consent is provided by a subject’s parent/legal guardian, the subject’s assent may also be required depending on local requirements.
- 2.Male or female adults 50 to 65 years of age; or male or female children 6 to 17 years of age at the time of enrollment.
- 3.Healthy subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of 13vPnC, are eligible.
- 5.Subjects or subjects’ parent/legal guardians are expected to be available for the duration of the study.
- 6.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.
- 7.Negative urine pregnancy test for all female subjects who are of childbearing potential.
- Subjects or parents/legal guardians who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
- History of severe adverse reaction, including hypersensitivity such as anaphylaxis, associated with a vaccine or vaccine component.
- Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or 13vPnC administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Immunocompromised persons with known or suspected immunodeficiency or who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer, HIV infection, or autoimmune disease.
- Severe chronic disorder, including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder which, in the investigator’s opinion, precludes the subject from participating in the study.
- Documented Streptococcus pneumoniae infection within the past 5 years before 13vPnC administration.
- Receipt of any plasma products or immunoglobulins within 60 days preceding 13vPnC administration or anticipated receipt before study completion.
- Vaccination with any licensed or investigational pneumococcal vaccine within the last year.
- Participation in other studies within 28 days before the current study begins and/or during study participation.
- Participation in observational studies is permitted.
- Permanent residence in a nursing home, or other residential care facility.
- An ambulatory subject who is a resident of a retirement home or village is eligible for the study.
- Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception throughout the study.
- Inclusion and exclusion criteria for participant selection, including age and sex.
- Age and sex to be mentioned in specific boxes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of AEs collected by the investigator after clinical evaluation and in response to nonspecific questions on the subject’s health.Immunogencity objective: Functional antibody titers as measured by serotype-specific OPA assays before and approximately 1 month after 13vPnC administration. Timepoint:Baseline and 28-42days after vaccination
- Secondary Outcome Measures
Name Time Method N/A N/A
Trial Locations
- Locations (25)
B. J. Medical College & Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
Bharati Vidyapeeth Deemed University Medical College Bharati Hospital & Research Centre
🇮🇳Pune, MAHARASHTRA, India
Bhatia Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Cheluvamba Hospital
🇮🇳Mysore, KARNATAKA, India
Chopda Medicare & Research Centre Pvt. Ltd
🇮🇳Nashik, MAHARASHTRA, India
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Department of Medicine, AMC MET Medical College and Sheth L. G. General Hospital
🇮🇳Ahmadabad, GUJARAT, India
Eesha Multi Speciality Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Getwell Hospital and Research Institute
🇮🇳Nagpur, MAHARASHTRA, India
K. G. Hospital and Post Graduate Medical Institute
🇮🇳Coimbatore, TAMIL NADU, India
Scroll for more (15 remaining)B. J. Medical College & Civil Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Bhagirathi SolankiPrincipal investigator09904025799drbhagirath@yahoo.co.in