13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India

• ClinicalTrials.gov Identifier: NCT02034877
• Recruitment Status: Completed
• First Posted: January 14, 2014
• Results First Posted: July 1, 2016
• Last Update Posted: July 1, 2016
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 10, 2014
• First Posted Date: January 14, 2014
• Results First Submitted Date: May 23, 2016
• Results First Posted Date: July 1, 2016
• Last Update Posted Date: July 1, 2016
• Study Start Date: August 2014
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 23, 2016)

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination [ Time Frame: Within 1 month after 13vPnC vaccination ]
  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.
• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination [ Time Frame: Before 13vPnC vaccination ]
  Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination [ Time Frame: 1 month after 13vPnC vaccination ]
  Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
• Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination [ Time Frame: Before 13vPnC vaccination, 1 month after 13vPnC vaccination ]
  GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
• Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination [ Time Frame: Before 13vPnC vaccination ]
  Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
• Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination [ Time Frame: 1 month after 13vPnC vaccination ]
  Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

Original Primary Outcome Measures (submitted: January 10, 2014)

• The proportion of subjects reporting adverse events (AEs) and serious adverse events (SAEs) within approximately 1 month after 13vPnC administration. [ Time Frame: Baseline to 1 month post vaccination ]
  Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) within approximately 1 month after 13vPnC administration.
• Functional antibody titers as measured by serotype-specific opsonophagocytic activity (OPA) assays before and approximately 1 month after 13vPnC administration. [ Time Frame: Baseline to 1 month post vaccination ]
  To describe the immune responses to the 13 pneumococcal serotypes induced by 13vPnC

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC

Intervention

• Biological: 13-valent Pneumococcal conjugate vaccine
  1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1
• Procedure: Blood sample collection
  10 mL of blood will be collected just before and approximately 1 month after vaccination.

Study Arms

Experimental: 1

Interventions:

• Biological: 13-valent Pneumococcal conjugate vaccine
• Procedure: Blood sample collection

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 10, 2014): 1200
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT02034877
• Other Study ID Numbers: B1851140; 2014-001174-34 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2016