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

NCT01964716 | Completed Phase 3 Results DMC

• 2 other identifiers: B46710012012-000482-21
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumococcal Vaccines

Keywords

Prevenar 13; 13vPnC; Healthy Subjects

Outcome Measures

Primary Outcomes (10)

• 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

  Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype.

  1 month after the infant series

• Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group

  Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype.

  1 month after the infant series

• Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group

  Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.

  Within 5 days after Dose 1(Day 2 to Day 6) of the infant series

• Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group

  Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.

  Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series

• Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group

  Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.

  Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series

• Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group

  Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.

  Within 5 days after Dose 1 (Day 2 to Day 6) of infant series

• Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group

  Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.

  Within 5 days after Dose 2 (Day 2 to Day 6) of infant series

• Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group

  Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.

  Within 5 days after Dose 3 (Day 2 to Day 6) of infant series

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series

  An AE was any untoward medical occurrence in a participants 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 are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state

  Dose 1 up to 28 to 42 days after dose 3

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1

  An AE was any untoward medical occurrence in a participants 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. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.

  Informed consent up to Dose 1

Secondary Outcomes (2)

• Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series

  1 month after the infant series

• Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series

  1 month after the infant series

Study Arms (2)

Multidose Vial Group

EXPERIMENTAL

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

Single-Dose Syringe Group

ACTIVE COMPARATOR

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

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

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.

Multidose Vial Group

Eligibility Criteria

• Age: 42 Days - 70 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Medical Research Council Unit, The Gambia

Fajara, The Gambia, West Africa, 000273, The Gambia

Location

Fajikunda Major Health Centre

Ksmd, The Gambia, The Gambia

Location

Related Publications (1)

• 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.

  PMID: 28479175 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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: October 17, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 13, 2015
• Results First Posted: March 13, 2015

Record last verified: 2015-02

Locations

TH (2)