Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01193335
First received: August 31, 2010
Last updated: May 14, 2013
Last verified: May 2013
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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 ]
| Estimated 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
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Poland | |
| Hanna Czajka Indywidualna | Recruiting |
| Krakow, Poland, 31-302 | |
| SP ZOZ Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego | Recruiting |
| Lodz, Poland, 91-347 | |
| Specjalistyczny ZOZ nad Matka i Dzieckiem, Oddzial Obserwacyjno Zakazny A, Szpital Dzieciecy | Recruiting |
| Poznan, Poland, 61-734 | |
| Szpital im. Sw. Jadwigi Slaskiej, Oddzial Dzieciecy | Recruiting |
| Trzebnica, Poland, 55-100 | |
| Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu | Recruiting |
| Wroclaw, Poland, 50-345 | |
| Spain | |
| Hospital Universitario Santiago de Compostela | Recruiting |
| Santiago de Compostela, A Coru, Spain, 15706 | |
| Complejo Hospitalario de Navarra | Recruiting |
| Pamplona, Navarra, Spain, 31008 | |
| Complexo Hospitalario Xeral Cies | Recruiting |
| Vigo, Pontevedra, Spain, 36204 | |
| Complejo Hospitalario Torrecardenas | Recruiting |
| Almeria, Spain, 04009 | |
| Hospital Universitario de La Paz | Recruiting |
| Madrid, Spain, 28046 | |
| Hospital 12 de Octubre | Recruiting |
| Madrid, Spain, 28041 | |
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: | May 14, 2013 |
| 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 May 23, 2013