CTRI/2025/03/083102
Active, not recruiting
Phase 4
A single blind, randomized, active-controlled, phase-IV study to evaluate immunogenicity and safety of Biological E’s 14-valent pneumococcal polysaccharide conjugate vaccine (PNEUBEVAX-14), administered to healthy children aged ≥5 years to 18 years and healthy adults aged ≥18 years and above.
Overview
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Biological E.Limited
- Enrollment
- 1,200
- Locations
- 15
- Primary Endpoint
- The proportion of subjects with anti PnCPS IgG concentration 0.35 microgram per ml against each of the vaccine serotype
Overview
Brief Summary
This is a prospective, single blind, randomized, active-controlled, phase-IV study to evaluate immunogenicity and safety of Pneubevax-14, administered as a single dose to children aged ≥5 years to <10 years (younger children), ≥10 years to <18 years (older children), and adults aged ≥18 years to <50 years and to elderly population (≥50 years and above).
Healthy children aged ≥5 to <10 years who are not previously vaccinated or those with incomplete infant series with Pneumococcal vaccines are eligible.
Healthy children aged from ≥10 to <18 years (older children) and adults aged ≥18 years and above are eligible if they had never received a dose of pneumococcal vaccine.
The total sample size to be enrolled would be 1200 healthy eligible subjects.
The study will be conducted in compliance with GSR 227(E), ICH and Indian good clinical practice guidelines in force at the time of study conduct.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Healthy subjects of either gender between 5 years to 18 years old children and 18 years and above aged adults at the time of vaccination.
- •2.Subject or Subject’s Parent(s) or LAR who after the nature of the study has been explained to them, have given written informed consent or assent (oral assent applicable to subjects 7 to 12 years of age and written assent applicable to subjects 12 to 18 years of age) according to local regulatory requirements prior to performance of any study specific procedure.
- •3.Subject or Subject’s Parent(s) or LAR’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures 4.Individuals in good health as determined by medical history, physical examination and laboratory investigations (only in adults), based on clinical judgment of the investigator.
- •5.Adult participant seronegative for human immunodeficiency virus, hepatitis B, and hepatitis C at screening.
- •6.Negative urine pregnancy test for female subjects of childbearing potential at screening and has practiced adequate contraception for 1 month prior to study intervention administration and has agreed to continue adequate contraception during the treatment period and for 1 month after completion of the study intervention administration.
- •7.Female participants of non-childbearing potential.
Exclusion Criteria
- •1.Evidence of previous Streptococcus pneumoniae infection.
- •2.Child in care 3.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 4.History of allergic or anaphylactic reaction to any vaccine or vaccine-related component or known hypersensitivity to any component of the study vaccine.
- •5.Acute disease and or fever at the time of vaccination.
- •6.Fever is defined as the endogenous elevation of at least one measured body temperature of 38°C (100.4°F).
- •7.Any acute or serious infection needing systemic antibiotics or antiviral treatment in last 7 days; 8.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.
- •9.Epilepsy, a history of seizures or convulsions, or a family history of mental illness; 10.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; 11.Subjects who have received any blood products, cytotoxic agents or radiotherapy within the last 3 months; 12.Any licensed or investigational 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; 13.Known or suspected immunosuppression or immunodeficiency; 14.Inability or unwillingness to abide by the requirements of the study; 15.Any participant who cannot be adequately followed for immunogenicity, safety and tolerability assessments according to the study plan; 16.Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study; 17.Suspicion or recent history (within the past year) of alcohol or drug abuse.
- •18.An employee (or first-degree relative of employee) of the Sponsor, the CRO, or any investigator or site personnel.
- •19.Any medical or social condition that in the opinion or 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.
Outcomes
Primary Outcomes
The proportion of subjects with anti PnCPS IgG concentration 0.35 microgram per ml against each of the vaccine serotype
Time Frame: At 28 days post vaccination.
Secondary Outcomes
- Proportion of subjects with solicited local and systemic adverse reactions or events post vaccination, in Pneubevax-14 and Prevenar-13 vaccinated subjects(During first 30 minutes observation period and for subsequent 7 consecutive day)
- Proportion of subjects with unsolicited adverse events (AEs) during the subsequent follow up period(28 days post vaccination.)
- Proportion of subjects with serious adverse events (SAEs) and medically attended AEs(For the total study period.)
- GMFR in anti-PnCPS IgG antibody concentrations against each of the vaccine serotype(From pre-vaccination levels.)
- Proportion of subjects with 2 and 4-fold rise in serotype specific anti-PnCPS IgG antibody concentration(From their baseline.)
- Geometric mean concentrations of anti-PnCPS IgG antibodies against each of the vaccine serotype(From pre-vaccination levels.)
Investigators
Dr Subhash Thuluva
Biological E.Limited
Study Sites (15)
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