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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01193335
First received: August 31, 2010
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
13-valent Pneumococcal Vaccine
Premature Birth
Immunization
Safety
Biological: 13-valent pneumococcal conjugate vaccine
Phase 4

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 4, Open-label Trial Describing the Safety, Tolerability, and Immunogenicity of the 13 Valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The proportion of subjects achieving a serotype specific IgG concentration ≥ 0.35 μg/mL measured 1 month after the infant series for each of the pneumococcal serotypes for each group and group 1 sub-group. [ Time Frame: Visit 4 (5 months) ] [ Designated as safety issue: Yes ]
  • The proportion of subjects with local injection site reactions and systemic events reported on any day within the 7-day period after each vaccination with the pneumococcal conjugate vaccine will be estimated for each group. [ Time Frame: Baseline to 13 months visit. ] [ Designated as safety issue: Yes ]
  • The proportion of subjects reporting AEs and SAEs through the course of the study. [ Time Frame: Baseline to visit 8 (36 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of subjects achieving a serotype specific IgG concentration ≥ 0.35 μg/mL measured 1 month after the toddler dose for each of the pneumococcal serotypes for each group and group 1 sub-group. [ Time Frame: Visit 6 (13 months) ] [ Designated as safety issue: Yes ]
  • Fold rise in antibody concentration from the pretoddler dose to 1 month after the toddler dose for each subject. [ Time Frame: Visit 5 (12 months) to Visit 6 (13 months) ] [ Designated as safety issue: Yes ]
  • Persistence of antibody response induced by 13vPnC for each serotype and for each group (and subgroup), 1 month after the infant series, before toddler dose, 1 month after the toddler dose, 1 year after the toddler dose, and 2 years after the toddler. [ Time Frame: Baseline to visit 8 (36 months) ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1: Preterm infants
Infant born at < 37 weeks of gestation.
Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Active Comparator: Group 2: Term infants
Infants born at ≥ 37 weeks of gestation
Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.

  Eligibility

Ages Eligible for Study:   42 Days to 98 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193335

Locations
Poland
NZOZ "HIPOKRATES-II" Sp. z o.o.
Krakow, Poland
Hanna Czajka Indywidualna Praktyka Lekarska
Krakow, Poland, 31-302
Uniwersytet Medyczny w Lodzi - Szpital im dr Wladyslawa Bieganskiego
Lodz, Poland, 91-347
Specjalistyczny ZOZ nad Matka i Dzieckiem
Poznan, Poland, 61-825
Szpital im Sw Jadwigi Slaskiej Oddzial Dzieciecy
Trzebnica, Poland, 55-100
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, Poland, 50-345
Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Complexo Hospitalario Xeral Cies
Vigo, Pontevedra, Spain, 36204
Complejo Hospitalario Torrecardenas
Almeria, Spain, 04009
Hospital Universitario de La Paz
Madrid, Spain, 28046
Hospital 12 de Octubre
Madrid, Spain, 28041
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
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: NCT01193335     History of Changes
Other Study ID Numbers: B1851037, 6096A1-4001
Study First Received: August 31, 2010
Last Updated: January 14, 2014
Health Authority: Spain: Ethic Committee and Agency of Medecines, Poland : Ethic Committee and Ministry of health

Keywords provided by Pfizer:
13-valent pneumococcal conjugate vaccine
premature
immunization
safety.

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014