CompletedPhase 4

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

India1,200 participantsStarted 2014-08

Plain-language 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.

Who can participate

Age range6 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination

Timeframe: Before 13vPnC vaccination

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 1 month after 13vPnC vaccination

Trial details

NCT IDNCT02034877

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07

Results submitted2016-05-23

View on ClinicalTrials.gov More Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC trials

Who can participate

Age range6 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination

Timeframe: Before 13vPnC vaccination

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 1 month after 13vPnC vaccination