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13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01964716
First received: September 9, 2013
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.

It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.


Condition Intervention Phase
Pneumococcal Vaccines
Biological: 13-valent pneumococcal conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Open-label Trial to Evaluate the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Formulated in Multi-dose Vials Given With Routine Pediatric Vaccinations in Healthy Infants

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The percentage of subjects achieving a serotype-specific IgG antibody concentration ≥0.35 µg/mL for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group. [ Time Frame: Approximately 20 weeks of age ] [ Designated as safety issue: No ]
  • The serotype-specific IgG geometric mean concentration (GMC) for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group (MDV group or SDS group). [ Time Frame: Approximately 20 weeks of age ] [ Designated as safety issue: No ]
  • The number of subjects reporting local reactions and systemic events in the 5 days after each vaccination in the multidose-vial group and in the single-dose-syringe group. [ Time Frame: Approximately 8 weeks, 12 weeks and 16 weeks of age ] [ Designated as safety issue: Yes ]
  • The number of subjects reporting AEs in the multidose-vial group and in the single-dose-syringe group. [ Time Frame: Approximately 8 weeks, 12 weeks , 16 weeks and 20 weeks of age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of subjects in a subset achieving a serotype-specific OPA titer ≥ lower limit of quantitation (LLOQ) for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group. [ Time Frame: Approximately 20 weeks of age ] [ Designated as safety issue: No ]
  • The serotype-specific OPA geometric mean titer (GMT) for each of the pneumococcal serotypes 1 month after the infant series for each vaccine group. [ Time Frame: Approximately 20 weeks of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multidose Vial Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation. Each dose is 0.5 mL
Biological: 13-valent pneumococcal conjugate vaccine
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Active Comparator: Single-Dose Syringe Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation. Each dose is 0.5 mL
Biological: 13-valent pneumococcal conjugate vaccine
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.

  Eligibility

Ages Eligible for Study:   42 Days to 70 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 42 to 70 days at enrollment.
  • Determined by medical history, physical examination, and clinical judgment to be eligible for the study
  • Weight of 3.5 kg or greater at the time of enrollment

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with pneumococcal conjugate vaccine.
  • Receipt of blood products or gamma-globulin since birth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964716

Locations
Gambia
Medical Research Council Unit, The Gambia
Fajara, The Gambia, West Africa, Gambia, 000273
Fajikunda Major Health Centre
Ksmd, The Gambia, Gambia
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01964716     History of Changes
Other Study ID Numbers: B4671001
Study First Received: September 9, 2013
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Prevenar 13
13vPnC
Healthy Subjects

ClinicalTrials.gov processed this record on November 23, 2014