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

Phase 4

Completed

• Conditions: Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
• Interventions: Biological: 13-valent Pneumococcal conjugate vaccine; Procedure: Blood sample collection

• Registration Number: NCT02034877
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-14
• Study Start: 2014-08
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-05
• Results First Submitted: 2016-05-23
• Results First Submitted QC: 2016-05-23
• Last Update Submitted: 2016-05-23
• Results First Posted: 2016-07-01
• Last Update Posted: 2016-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Blood sample collection	-
1	13-valent Pneumococcal conjugate vaccine	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination	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	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	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	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	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	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.

Trial Locations

Locations (16)

S.B.K.S Medical Institute & Research Centre; 🇮🇳 Vadodara, Gujarat, India

M.S. Ramaiah Medical College and Hospitals; 🇮🇳 Bangalore, Karnataka, India

Padmashree Dr. D. Y. Patil Medical College; 🇮🇳 Pune, Maharashtra, India

M.S. Ramaiah Cliical Research Centre, M.S. Ramaiah Medical College & Hospitals; 🇮🇳 Bangalore, Karnataka, India

B. J. Medical College & Civil Hospital; 🇮🇳 Ahmedabad, Gujarat, India

Bhatia Hospital; 🇮🇳 Mumbai, India

King George Hospital; 🇮🇳 Visakhapatnam, Andhra Pradesh, India

Cheluvamba Hospital; 🇮🇳 Mysore, Karnataka, India

Samvedna Hospital; 🇮🇳 Varanasi, Uttar Pradesh, India

Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd.; 🇮🇳 Hubli, Karnataka, India

Christian Medical College; 🇮🇳 Vellore, Tamilnadu, India

Medipoint Hospitals Pvt. Ltd.; 🇮🇳 Pune, Maharashtra, India

Chopda Medicare and Research Centre Pvt. Ltd; 🇮🇳 Nashik, Maharashtra, India

Orange City Hospital and Research Institute; 🇮🇳 Nagpur, India

Supe Heart & Diabetes Hospital and Research Centre; 🇮🇳 Nasik, Maharashtra, India

Niramaya Hospital; 🇮🇳 Chinchwad Pune, Maharashtra, India