Clinical trial NCT01964716: 13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
Official title: A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Vaccines
Keywords: Prevenar 13
13vPnC
Healthy Subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 500
Sex: ALL
Minimum age (years): 42
Maximum age (years): 70
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
timeFrame: 1 month after the infant series
measure: Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
timeFrame: Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
measure: Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
timeFrame: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
measure: Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
timeFrame: Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
measure: Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
timeFrame: Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
measure: Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
timeFrame: Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
measure: Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
timeFrame: Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
timeFrame: Dose 1 up to 28 to 42 days after dose 3
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
timeFrame: Informed consent up to Dose 1
Secondary outcomes:
measure: Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
timeFrame: 1 month after the infant series
measure: Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
timeFrame: 1 month after the infant series
Other outcomes:
Locations:
city: Fajara
country: Gambia
facility: Medical Research Council Unit, The Gambia
state: The Gambia, West Africa
city: Ksmd
country: Gambia
facility: Fajikunda Major Health Centre
state: The Gambia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Idoko OT, Mboizi RB, Okoye M, Laudat F, Ceesay B, Liang JZ, Le Dren-Narayanin N, Jansen KU, Gurtman A, Center KJ, Scott DA, Kampmann B, Roca A. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial. Vaccine. 2017 May 31;35(24):3256-3263. doi: 10.1016/j.vaccine.2017.04.049. Epub 2017 May 4.