Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Secondary endpoint revised
    • Primary endpoints revised (2)
    v16
  2. Re-verified, no change to tracked fieldsv15
  3. Results first posted: Nov 15, 2010
    • Primary endpoints: 1 to 2
    • Secondary endpoints expanded, about 22 words
    v14
  4. Study completion date: Dec 2009 to Feb 2010v13
  5. Primary completion date changed from estimate of Dec 2008 to Oct 2009
    • Study completion date changed from estimate of Dec 2008 to Dec 2009
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 354 to confirmed 708
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Study sites: 11 to 12v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (11)
    v9
  4. Trial status: Active, Not Recruiting to Recruiting
    • Study sites revised (11)
    v8
  5. Re-verified, no change to tracked fieldsv7
  6. Primary completion date: Dec 2008
    • Study completion date: Sep 2007 to Dec 2008
    • Interventions: 13-valent Pneumococcal Conjugate Vaccine (Biological) to 13-valent Pneumococcal Conjugate Vaccine (Biological), 7 valent pneumococcal conjugate vaccine (Biological)
    • Study arms: 0 to 2
    v6
  7. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (11)
    v5
  8. Study sites: 3 to 11v4
  9. Enrollment target: 330 to 354v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.
Trial Details
NCT Number NCT00452790
Lead Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Conditions
(from sponsor)		 Pneumococcal Infections
Related terms Pneumococcal Infections
Enrollment 708 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov