Clinical trial NCT01193335: Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
Official title: A Phase 4, Open-label Trial Describing The Safety, Tolerability, And Immunogenicity Of The 13 Valent Pneumococcal Conjugate Vaccine In Preterm Compared To Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: 13-valent Pneumococcal Vaccine
Premature Birth
Immunization
Safety
Keywords: 13-valent pneumococcal conjugate vaccine
premature
immunization
safety.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 200
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
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
timeFrame: 1 month after the infant series
measure: Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series
timeFrame: Within 7 days after Dose 1 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series
timeFrame: Within 7 days after Dose 2 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series
timeFrame: Within 7 days after Dose 3 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose
timeFrame: Within 7 days after the toddler dose
measure: Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series
timeFrame: Within 7 days after Dose 1 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series
timeFrame: Within 7 days after Dose 2 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series
timeFrame: Within 7 days after Dose 3 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose
timeFrame: Within 7 days after the toddler dose
measure: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series
timeFrame: Dose 1 up to 1 month after Dose 3 (infant series)
measure: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series
timeFrame: 1 Month after Dose 3 of the infant series up to toddler dose
measure: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose
timeFrame: Toddler dose up to 1 Month after toddler dose
measure: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose
timeFrame: 1 month after toddler dose up to 1-year follow-up
measure: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose
timeFrame: 1-year follow-up after toddler dose to 2-year follow-up after toddler dose
Secondary outcomes:
measure: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
timeFrame: Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose
measure: 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
timeFrame: 1 Month After Infant Series
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
timeFrame: 1 month after the toddler dose
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
timeFrame: Before Toddler Dose (pre-vaccination)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
timeFrame: 1 Month After Toddler Dose
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
timeFrame: 1 Year After Toddler Dose
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
timeFrame: 2 Years After Toddler Dose
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
timeFrame: 1 Month After Infant Series
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
timeFrame: Before Toddler Dose (pre-vaccination)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
timeFrame: 1 Month After Toddler Dose
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
timeFrame: 1 Year After Toddler Dose
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
timeFrame: 2 Years After Toddler Dose
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series
timeFrame: 1 Month After Infant Series
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
timeFrame: Before the toddler dose (pre-vaccination)
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
timeFrame: 1 Month After Toddler Dose
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
timeFrame: 1 Year After Toddler Dose
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
timeFrame: 2 Years After Toddler Dose
measure: Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
timeFrame: 1 Month After Infant Series
measure: Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
timeFrame: Before Toddler Dose (pre-vaccination)
measure: Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
timeFrame: 1 Month After Toddler Dose
measure: Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
timeFrame: 1 Year After Toddler Dose
measure: Percentage of Participants With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
timeFrame: 2 Years After Toddler Dose
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: NZOZ "HIPOKRATES-II" Sp. z o.o.
city: Krakow
country: Poland
facility: Hanna Czajka Indywidualna Praktyka Specjalistyczna Lekarska
city: Lodz
country: Poland
facility: SP ZOZ Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego w Lodzi
city: Poznan
country: Poland
facility: Specjalistyczny ZOZ nad Matka i Dzieckiem
city: Trzebnica
country: Poland
facility: Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario de Santiago de Compostela
state: A Coruña
city: Vigo
country: Spain
facility: Complexo Hospitalario Xeral Cies
state: Pontevedra
city: Almeria
country: Spain
facility: Complejo Hospitalario DE Torrecardenas
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.