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

NCT02034877 | Completed Phase 4 Results

• 2 other identifiers: B18511402014-001174-34
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 16

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.

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

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) 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.

  Within 1 month after 13vPnC vaccination

• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 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.

  Before 13vPnC vaccination

• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 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.

  1 month after 13vPnC vaccination

• Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 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.

  Before 13vPnC vaccination, 1 month after 13vPnC vaccination

• Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 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.

  Before 13vPnC vaccination

• Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 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.

  1 month after 13vPnC vaccination

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

13-valent Pneumococcal conjugate vaccine BIOLOGICAL

1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1

1

Blood sample collection PROCEDURE

10 mL of blood will be collected just before and approximately 1 month after vaccination.

1

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (16)

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

B. J. Medical College & Civil Hospital

Ahmedabad, Gujarat, 380016, India

Location

S.B.K.S Medical Institute & Research Centre

Vadodara, Gujarat, 391760, India

Location

M.S. Ramaiah Cliical Research Centre, M.S. Ramaiah Medical College & Hospitals

Bangalore, Karnataka, 560054, India

Location

M.S. Ramaiah Medical College and Hospitals

Bangalore, Karnataka, 560054, India

Location

Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd.

Hubli, Karnataka, 580021, India

Location

Cheluvamba Hospital

Mysore, Karnataka, 570001, India

Location

Niramaya Hospital

Chinchwad Pune, Maharashtra, 411019, India

Location

Supe Heart & Diabetes Hospital and Research Centre

Nashik, Maharashtra, 422002, India

Location

Chopda Medicare and Research Centre Pvt. Ltd

Nashik, Maharashtra, 422005, India

Location

Medipoint Hospitals Pvt. Ltd.

Pune, Maharashtra, 411007, India

Location

Padmashree Dr. D. Y. Patil Medical College

Pune, Maharashtra, 411018, India

Location

Christian Medical College

Vellore, Tamil Nadu, 632 004, India

Location

Samvedna Hospital

Varanasi, Uttar Pradesh, 221005, India

Location

Bhatia Hospital

Mumbai, 400007, India

Location

Orange City Hospital and Research Institute

Nagpur, 440015, India

Location

Related Publications (2)

• 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.

  PMID: 28881165 DERIVED

• 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.

  PMID: 28719496 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: PREVENTION
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 1, 2016
• Results First Posted: July 1, 2016

Record last verified: 2016-05

Locations

IN (16)