Indian Clinical Trials

An open-label trial was conducted in India to assess the safety and immunogenicity of PCV13 in adults  aged 50–65 years. This study was performed as a part of post-licensure commitment by the Drugs  Controller General of India, and the New Drug Advisory Committee.

Abbreviations: PCV13: 13-valent pneumococcal conjugate vaccine

Reference
Solanki BB, Juergens C, Chopada MB, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An  open-label trial. Hum Vaccin Immunother. 2017;13(9):2065–2071.

Please click on Summary of Prescribing Information link to view safety and adverse events information of Prevenar 13 ®. For the use only of registered medical practitioner, or a hospital or a laboratory.

This open-label, single-arm study was conducted at 12 sites across 6 states in India. The different states involved were Maharashtra (n=591), Karnataka (n=98), Uttar Pradesh (n=34), Gujarat (n=165), Tamil Nadu  (n=25), and Andhra Pradesh (n=87). Eligible population included participants with pre-existing stable disease, i.e. disease not requiring a  significant change in hospitalization or therapy, for worsening of the disease 12 weeks before receiving  PCV13. Exclusion criteria included individuals with a documented S. pneumoniae infection in the past 5  years, immunocompromised or with immunodeficiency, previous pneumococcal vaccination within the  last year, or previously treated with immunosuppressive therapy. Informed consent was obtained from all  participants in accordance with requirements of the Indian Ministry of Health and Welfare.

Participants  received a single-dose of PCV13 (0.5 mL). The endpoints of the study included the measurement of functional antibody opsonophagocytic activity  (OPA) titers induced by the 13 pneumococcal serotypes contained in PCV13 at 2 time points: one before  and other at 1 month after vaccination

Abbreviations: PCV13: 13-valent pneumococcal conjugate vaccine

Reference
Solanki BB, Juergens C, Chopada MB, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An  open-label trial. Hum Vaccin Immunother. 2017;13(9):2065–2071.

Please click on Summary of Prescribing Information link to view safety and adverse events information of Prevenar 13 ®. For the use only of registered medical practitioner, or a hospital or a laboratory.

A total of 1000 adults were enrolled in the study, 999 were vaccinated with PCV13, and 993 adults completed  the study. The median age of the study population at the time of vaccination was 57.4 years, and 58.6% of  the participants were men.

Among the participants, 400 were randomized to the immunogenicity subset, and 388 were included in the immunogenicity analysis population. None of the participants had immunization history with PPSV23 or  any other pneumococcal vaccine.

Analysis of the immune responses showed a significant increase in the OPA geometric mean titers (GMTs) for all 13 serotypes. This increase was observed from before to approximately 1 month after vaccination.  The lower limit of the 2-sided 95% CI for the geometric mean fold rise (GMFR) was >1 (Table 1).1

Serious adverse events or deaths were not reported. Moreover, no adverse event led to the withdrawal of the participant from the study.

Table 1: The Geometric mean fold rise of pneumococcal OPA GMTs prior to and one month after PCV13 vaccination  (Adapted from Solanki et al. Hum Vaccin Immunother. 2017;13(9):2065–2071)

Prevenar 13_Indian Clinical Trials_Results

Abbreviations: PCV13: 13-valent pneumococcal conjugate vaccine; PPSV23: 23-valent pneumococcal plain-polysaccharide vaccine.

Reference
1. Solanki BB, Juergens C, Chopada MB, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An  open-label trial. Hum Vaccin Immunother. 2017;13(9):2065–2071.

Please click on Summary of Prescribing Information link to view safety and adverse events information of Prevenar 13 ®. For the use only of registered medical practitioner, or a hospital or a laboratory.

There is lack of data on the effect of PCV13 immunization on clinical outcomes.

Abbreviations: PCV13: 13-valent pneumococcal conjugate vaccine

Reference
Solanki BB, Juergens C, Chopada MB, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An  open-label trial. Hum Vaccin Immunother. 2017;13(9):2065–2071.

Please click on Summary of Prescribing Information link to view safety and adverse events information of Prevenar 13 ®. For the use only of registered medical practitioner, or a hospital or a laboratory.

• PCV13 vaccination is well tolerated and immunogenic in Indian adults aged 50–65 years.

• PCV13 can potentially protect Indian adults against vaccine-type pneumococcal disease.

• Single dose of PCV13 has the potential to protect against vaccine-type pneumococcal disease in adults aged 50 to 65 years.

Abbreviations: PCV13: 13-valent pneumococcal conjugate vaccine

Reference
Solanki BB, Juergens C, Chopada MB, et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age in India: An  open-label trial. Hum Vaccin Immunother. 2017;13(9):2065–2071.

Please click on Summary of Prescribing Information link to view safety and adverse events information of Prevenar 13 ®. For the use only of registered medical practitioner, or a hospital or a laboratory.

PP-PNA-IND-0556, 12th Feb 2021