Clinical trial to demonstrate the immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23) in healthy adults

A Randomized, Double-blinded, Multicenter Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Adults

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036860

Enrollment

268

Registered

2021-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: PPSV23: 23-valent Pneumococcal polysaccharide vaccine, PPSV23 (Yuxi Walvax Biotechnology Co. Ltd.) A single dose (0.5 mL) of PPSV23 vaccine will be administered to the subject on Day

Eligibility

Inclusion criteria

Inclusion criteria: Subjects aged between 18 to 65 years; Subjects willing to give written informed consent prior to the study entry; Subjects with good health as determined by: Medical history; Physical examination; Clinical judgment of the investigator. Subjects able to attend all scheduled visits and comply with all study procedures.

Exclusion criteria

Exclusion criteria: Subjects administered with any pneumococcal vaccine before vaccination; Subjects with history of pneumococcal infection; Women in pregnancy or lactation period in trial period; Subjects with allergic history or any SAE after vaccination,such as allergy, urticaria, dyspnoea, angioedema Subjects with known or suspected immune dysfunction, including persons with congenital immunodeficiency or persons with HIV positive; Subjects with functional or anatomic asplenia; Patients treated with chemotherapy in past 5 years or administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in 6 months preceding the vaccine trial; Subjects with receipt of blood or blood-derived products in 3 months preceding vaccination; Subjects participating in another clinical study investigating a vaccine or drug in 30 days preceding vaccination; Subjects with receipt of any live virus vaccine in 30 days preceding vaccination; Subjects with receipt of any subunit vaccine and inactivated vaccine in the 14 days before vaccination; Subjects with thrombocytopenia or bleeding disorder; Subjects with history of asthma, angioneurotic edema, diabetes mellitus or malignancy tumour; Subjects with history of thyroid gland excision or treatment for thyroid gland disease in last 12 months. Subjects with hypertension or whose blood pressure is still above 145/95mmHg even with drug treatment; Subjects with history of eclampsia, epilepsia or psychosis; Subjects with febrile illness (temperature Ã¢â?°Â¥ 38Ã?Â°C) in 3 days or any acute illness/infection in 7 days preceding vaccination; Subjects with anti-tuberculosis prophylaxis or therapy in progress; Those who cannot fulfil the protocol or cannot sign the informed consent form for any medical, psychological, social, occupational and other reasons, according to investigator judgment

Design outcomes

Primary

Measure	Time frame
Percentage of subjects exhibiting a Ã¢â?°Â¥ 2-fold increase in antipneumococcal IgG antibody level for all included 23 serotypes after vaccination in each group. Geometric mean fold increase (GMFI) and geometric mean concentration/titer (GMCs/GMTs) of IgG after vaccination in each group.Timepoint: Antibody response at Day 28 post-vaccination	—

Secondary

Measure	Time frame
Incidence of SAE during the entire study periodTimepoint: During the entire study period;Incidence of systemic and local adverse reactions in healthy subjects after vaccination (up to 30 minutes) and in 7 subsequent daysTimepoint: Day 0-7 post-vaccination;Incidence of unsolicited adverse eventsTimepoint: Day 28 post-vaccination	—

Countries

India

Contacts

Public ContactDr Nidhi Singh

Clinical Research Network India

nidhisingh@crnindia.org9695237796

Outcome results