Clinical trial NCT02034877: 13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India
Official title: A Phase 4/3, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
Keywords: 13-valent pneunococcal conjugate vaccine
pneumococcal disease prevention; safety and immunogenicity study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-01-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.


Eligibility criteria: Inclusion Criteria:

Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.

Exclusion Criteria:

Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination
timeFrame: Within 1 month after 13vPnC vaccination
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination
timeFrame: Before 13vPnC vaccination
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination
timeFrame: 1 month after 13vPnC vaccination
measure: Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination
timeFrame: Before 13vPnC vaccination, 1 month after 13vPnC vaccination
measure: Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination
timeFrame: Before 13vPnC vaccination
measure: Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination
timeFrame: 1 month after 13vPnC vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: B. J. Medical College & Civil Hospital
state: Gujarat
city: Vadodara
country: India
facility: S.B.K.S Medical Institute & Research Centre
state: Gujarat
city: Bangalore
country: India
facility: M.S. Ramaiah Cliical Research Centre, M.S. Ramaiah Medical College & Hospitals
state: Karnataka
city: Bangalore
country: India
facility: M.S. Ramaiah Medical College and Hospitals
state: Karnataka
city: Hubli
country: India
facility: Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd.
state: Karnataka
city: Mysore
country: India
facility: Cheluvamba Hospital
state: Karnataka
city: Chinchwad Pune
country: India
facility: Niramaya Hospital
state: Maharashtra
city: Nashik
country: India
facility: Chopda Medicare and Research Centre Pvt. Ltd
state: Maharashtra
city: Nasik
country: India
facility: Supe Heart & Diabetes Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Medipoint Hospitals Pvt. Ltd.
state: Maharashtra
city: Pune
country: India
facility: Padmashree Dr. D. Y. Patil Medical College
state: Maharashtra
city: Vellore
country: India
facility: Christian Medical College
state: Tamilnadu
city: Varanasi
country: India
facility: Samvedna Hospital
state: Uttar Pradesh
city: Mumbai
country: India
facility: Bhatia Hospital
city: Nagpur
country: India
facility: Orange City Hospital and Research Institute
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Solanki BB, Juergens C, Chopada MB, Supe P, Sundaraiyer V, Le Dren-Narayanin N, Cutler MW, Gruber WC, Scott DA, Schmoele-Thoma B. 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 Sep 2;13(9):2065-2071. doi: 10.1080/21645515.2017.1331796.
citation: Agarkhedkar S, Juergens C, Balasundaram K, Agarkhedkar S, Sundaraiyer V, Le Dren-Narayanin N, Cutler MW, Gruber WC, Scott DA, Schmoele-Thoma B; B1851140 Study Team. Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Children 6-17 Years of Age in India: An Open-label Trial. Pediatr Infect Dis J. 2017 Nov;36(11):e283-e285. doi: 10.1097/INF.0000000000001695.