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

Phase 3

Completed

• Registration Number: CTRI/2021/09/036860
• Lead Sponsor: GCChemie Pharmie Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-03-02
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 268

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

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 â�¥ 38�°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

Study & Design

• Study Type: Interventional
• Study Design: Not specified