Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.

NCT01193335 | Completed Phase 4 Results DMC

• 3 other identifiers: B18510376096A1-40012009-017332-41
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 12

Brief Summary

The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.

Conditions

13-valent Pneumococcal Vaccine; Premature Birth; Immunization; Safety

Keywords

13-valent pneumococcal conjugate vaccine; premature; immunization; safety.

Outcome Measures

Primary Outcomes (15)

• Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After Infant Series

  Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on the observed proportion of participants. Here 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.

  1 month after the infant series

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

  Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

  1 month after the infant series

• Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series

  Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

  Within 7 days after Dose 1 of the infant series

• Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series

  Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

  Within 7 days after Dose 2 of the infant series

• Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series

  Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

  Within 7 days after Dose 3 of the infant series

• Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose

  Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes 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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

  Within 7 days after the toddler dose

• Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series

  Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.

  Within 7 days after Dose 1 of the infant series

• Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series

  Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.

  Within 7 days after Dose 2 of the infant series

• Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series

  Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.

  Within 7 days after Dose 3 of the infant series

• Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose

  Systemic events (fever \>=38 degrees Celsius \[C\], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Participants may be represented in more than 1 category.

  Within 7 days after the toddler dose

• Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series

  An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Dose 1 up to 1 month after Dose 3 (infant series)

• Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series

  An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  1 Month after Dose 3 of the infant series up to toddler dose

• Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose

  An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Toddler dose up to 1 Month after toddler dose

• Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose

  An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  1 month after toddler dose up to 1-year follow-up

• Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose

  An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  1-year follow-up after toddler dose to 2-year follow-up after toddler dose

Secondary Outcomes (23)

• Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose

  Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose

• Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C

  1 Month After Infant Series

• Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose

  1 month after the toddler dose

• Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C

  1 month after the toddler dose

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose

  Before Toddler Dose (pre-vaccination)

Study Arms (2)

Group 1: Preterm infants

ACTIVE COMPARATOR

Infant born at \< 37 weeks of gestation.

Biological: 13-valent pneumococcal conjugate vaccine

Group 2: Term infants

ACTIVE COMPARATOR

Infants born at ≥ 37 weeks of gestation

Biological: 13-valent pneumococcal conjugate vaccine

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.

Group 1: Preterm infants

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.

You may not qualify if:

• Previous vaccination with pneumococcal vaccine,Haemophilus influenzae type B (Hib) conjugate vaccine, meningococcal type C conjugate vaccine, or diphtheria, tetanus, pertussis, or poliovirus vaccines.
• Previous anaphylactic reaction or allergy to any vaccine
• Contraindication to vaccination
• Known or suspected immune deficiency or immune suppression
• Major known congenital malformation or serious chronic disorder
• Significant neurological disorder
• Participation to another study

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

NZOZ "HIPOKRATES-II" Sp. z o.o.

Krakow, 31-223, Poland

Location

Hanna Czajka Indywidualna Praktyka Specjalistyczna Lekarska

Krakow, 31-302, Poland

Location

SP ZOZ Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego w Lodzi

Lodz, 91-347, Poland

Location

Specjalistyczny ZOZ nad Matka i Dzieckiem

Poznan, 61-825, Poland

Location

Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny

Trzebnica, 55-100, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

Wroclaw, 50-345, Poland

Location

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Complejo Hospitalario DE Torrecardenas

Almería, Almeria, 04009, Spain

Location

Complexo Hospitalario Xeral Cies

Vigo, Pontevedra, 36204, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario de La Paz

Madrid, 28046, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

Location

Related Publications (2)

• Martinon-Torres F, Wysocki J, Center KJ, Czajka H, Majda-Stanislawska E, Omenaca F, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Blazquez-Gamero D, Moreno-Galarraga L, Giardina PC, Sun G, Gruber WC, Scott DA, Gurtman A. Circulating Antibody 1 and 2 Years After Vaccination With the 13-Valent Pneumococcal Conjugate Vaccine in Preterm Compared With Term Infants. Pediatr Infect Dis J. 2017 Mar;36(3):326-332. doi: 10.1097/INF.0000000000001428.

  PMID: 27902652 DERIVED

• Martinon-Torres F, Czajka H, Center KJ, Wysocki J, Majda-Stanislawska E, Omenaca F, Bernaola Iturbe E, Blazquez Gamero D, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Giardina PC, Patterson S, Gruber WC, Scott DA, Gurtman A. 13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants. Pediatrics. 2015 Apr;135(4):e876-86. doi: 10.1542/peds.2014-2941. Epub 2015 Mar 16.

  PMID: 25780077 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 1, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 11, 2017
• Results First Posted: February 4, 2015

Record last verified: 2016-09

Locations

ES (6); PL (6)